A Phase 3, Prospective, Multicenter, Open-label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (ADYNOVATE) Administered for Prophylaxis and Treatment of Bleeding in Chinese Previously Treated Patients With Severe Hemophilia A (FVIII <1%)

The main aim of the study is to determine how well Adynovate works to decrease bleeding in previously treated Chinese men and boys with severe hemophilia A when given prophylactically.
Participants will be treated with Adynovate twice a week for 26 weeks or until participants have received 50 days of treatment with Adynovate (whichever takes longer). Participants will need to visit their study clinic several times during their participation.

Start Date27 Mar 2023

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

CTR20223385

/ CompletedPhase 3

一项在既往接受过治疗的中国重度血友病A（FVIII<1%）患者中评价注射用重组人凝血因子VIII（ADYNOVATE）预防和治疗出血的有效性、安全性和药代动力学的前瞻性、多中心、开放性III期研究

[Translation] A prospective, multicenter, open-label Phase III study to evaluate the efficacy, safety, and pharmacokinetics of recombinant human coagulation factor VIII for injection (ADYNOVATE) in the prevention and treatment of bleeding in previously treated Chinese patients with severe hemophilia A (FVIII <1%)

主要目的：根据总ABR评估ADYNOVATE用于预防性治疗中国重度A型血友病受试者的有效性。次要目的：基于出血部位的ABR和病因，评估ADYNOVATE用于预防性治疗的有效性评估ADYNOVATE用于治疗研究期间非手术突破性出血事件的总体止血有效性评估ADYNOVATE用于围手术期出血管理（如果在研究期间进行小手术）的有效性通过评估AE、严重AE（SAE）以及具有临床意义的生命体征和临床实验室参数结果来评价ADYNOVATE的安全性根据产生FVIII抑制性抗体和ADYNOVATE结合抗体的发生率评价ADYNOVATE的安全性和免疫原性评价ADYNOVATE在中国受试者中的PK

[Translation]

Primary Objectives: To evaluate the effectiveness of ADYNOVATE for prophylactic treatment of Chinese subjects with severe hemophilia A based on total ABR. Secondary Objectives: To evaluate the effectiveness of ADYNOVATE for prophylactic treatment based on ABR and etiology of bleeding site To evaluate the overall hemostatic effectiveness of ADYNOVATE for the treatment of non-surgical breakthrough bleeding events during the study period To evaluate the effectiveness of ADYNOVATE for perioperative bleeding management (if minor surgery is performed during the study period) To evaluate the safety of ADYNOVATE by evaluating AEs, serious AEs (SAEs), and clinically significant results of vital signs and clinical laboratory parameters To evaluate the safety and immunogenicity of ADYNOVATE based on the incidence of FVIII inhibitory antibodies and ADYNOVATE binding antibodies To evaluate the PK of ADYNOVATE in Chinese subjects

Start Date27 Mar 2023

Sponsor / Collaborator

Baxalta Manufacturing SARL

[+2]

NCT05042440

/ CompletedPhase 1

A Phase 1, Single-Site, Open-Label Study to Assess Pharmacokinetics of Efanesoctocog Alfa (BIVV001), Standard Half-Life and Extended Half-Life FVIII After Each Single Intravenous Injection in a Fixed Sequence, in Previously Treated Adults With Severe Hemophilia A

Primary objective
• To assess the half-life of BIVV001, Standard Half-Life (SHL) rFVIII and Extended Half-Life (EHL) rFVIII after a single intravenous (IV) injection
Secondary objectives
To characterize additional pharmacokinetic (PK) parameters of BIVV001, SHL rFVIII and EHL rFVIII after a single IV injection
To evaluate the safety and tolerability of a single IV injection of BIVV001

Start Date11 Aug 2021

Sponsor / Collaborator

Sanofi SA

100 Clinical Results associated with Rurioctocog alfa pegol

100 Translational Medicine associated with Rurioctocog alfa pegol

100 Patents (Medical) associated with Rurioctocog alfa pegol

Literatures (Medical) associated with Rurioctocog alfa pegol

01 Dec 2024·Blood Research

Real-world insights into the management of hemophilia A in Italy: treatment patterns and healthcare resource utilization

Article

Author: Perrone, Valentina ; Cappuccilli, Maria ; Leogrande, Melania ; Esposti, Luca Degli

AbstractPurposeThis real-world analysis described the Hemophilia A (HA) population in Italy, evaluating drug utilization and consumption of factor VIII (FVIII) products of patients under prophylaxis and on-demand therapy.MethodsFrom Jan-2017 to Jun-2022, male patients with HA were identified through prescriptions of FVIII products [extended half-life FVIII, standard half-life recombinant FVIII, and plasma-derived FVIII (EHL FVIII, SHL rFVIII, and pdFVIII, respectively)], or emicizumab or FVIII plus von Willebrand factor or HA-related hospitalization using administrative flows of Italian healthcare entities. Patients on treatment with FVIII products during 2021–2022 were stratified by treatment regimen (prophylaxis/on-demand). The mean annual consumption expressed in International Units (IU) of EHL FVIII and SHL FVIII in patients treated during 2021–2022 having at least 12-month follow-up were assessed.ResultsAmong included HA patients, 145 (39.5%) received EHL FVIII and 222 (60.5%) SHL FVIII. Of 165 patients on prophylaxis, 105 (64%) received an EHL FVIII and 60 (36%) an SHL FVIII. The mean annual consumption of FVIII was 336,700 IU (median 319,000 IU) for EHL FVIII and 440,267 IU (median 360,500 IU) for SHL FVIII. Specifically, for patients on EHL FVIII, the most common drugs were efmoroctocog alfa (N = 51) and damoctocog alfa pegol (N = 50), followed by turoctocog alfa pegol (N = 25) and rurioctocog alfa pegol (N = 19). Of 702 HA patients initially treated with FVIII products, 74 (10.5%) switched to emicizumab during follow-up.ConclusionThese findings revealed an extensive use of EHL FVIII products, suggesting growing efforts from clinicians to optimize prophylactic strategies and achieve better bleeding protection.

01 Dec 2024·Blood Research

Evaluation of FVIII pharmacokinetic profiles in Korean hemophilia A patients assessed with myPKFiT: a retrospective chart review

Article

Author: Park, Sang Kyu ; Choi, Eun Jin ; Jung, Aeran ; Hwang, Taiju ; Yoo, Ki-Young ; Park, Young-Shil

AbstractPurposeThis study aimed to investigate the pharmacokinetics (PK) of factor VIII (FVIII) in Korean patients, as limited information is available on the PK of FVIII in this population.MethodsWe collected the FVIII PK results from patients with moderate-to-severe hemophilia A using myPKFiT. PK variations were assessed according to age, blood type, inhibitor history, von Willebrand factor antigen (vWF:Ag) level, and body mass index. Additionally, the correlation between the PK profile and prophylaxis regimen was specifically analyzed for each product in severe cases.ResultsThe PK data of 48 and 81 patients treated with octocog alfa and rurioctocog alfa pegol, respectively, were obtained. The median half-lives of octocog alfa and rurioctocog alfa pegol were 9.9 (range: 6.3–15.2) h and 15.3 (range: 10.4–23.9) h, respectively. The PK profiles for each product did not differ according to age group; however, blood type-O patients had shorter half-lives and time to 1% compared to non-blood type-O patients. In regression analysis, the PK of octocog alfa showed a statistically significant difference according to age, whereas the PK of rurioctocog alfa pegol correlated with vWF:Ag. Only the frequency of rurioctocog alfa pegol use showed a statistically significant difference in relation to time to 1%, although the coefficient of determination was small.ConclusionThis study confirmed significant interpatient variation in the PK of FVIII among Korean patients with hemophilia A. To achieve optimized prophylaxis, personalizing the regimen based on the PK profile of each individual patient is essential.

01 Sep 2024·Drugs in R&D

Damoctocog Alfa Pegol, a PEGylated B-domain Deleted Recombinant Extended Half-life Factor VIII for the Treatment of Hemophilia A: A Product Review

Review

Author: Poulsen, Lone H ; Shah, Anita ; Solms, Alexander ; Ducore, Jonathan ; Simpson, Mindy ; Meijer, Karina ; Lalezari, Shadan ; Kenet, Gili ; Holme, Pål André ; Di Minno, Giovanni ; Reding, Mark T ; Mancuso, Maria Elisa

Damoctocog alfa pegol (BAY 94-9027, Jivi^®), is a site-specifically PEGylated, extended half-life recombinant factor VIII (FVIII) that is approved in several European and non-European countries for on-demand treatment and prophylaxis of bleeding in previously treated patients aged ≥ 12 years with hemophilia A. Reliable measurements can be obtained using most one-stage and chromogenic FVIII assays over a wide concentration range. The efficacy, safety and pharmacokinetics (PK) of damoctocog alfa pegol have been studied extensively in the PROTECT VIII clinical trials, and its long-term safety and effectiveness profile is continuing to build through observational and interventional real-world studies. The PK of damoctocog alfa pegol was shown to be improved as compared with that of sucrose-formulated rFVIII (rFVIII-FS, Kogenate^®), and was also demonstrated to be non-inferior to and, for some variables, more favorable than rFVIII-Fc fusion protein, efmoroctocog alfa (Elocta^®; NCT03364998), rurioctocog alfa pegol (BAX 855, Adynovate^®/Adynovi^®; NCT04015492), and antihemophilic factor (recombinant) plasma/albumin-free method (rAHF-PFM, Advate^®; NCT02483208). Damoctocog alfa pegol was generally well tolerated and none of the patients in any of the clinical trials, including the PROTECT VIII clinical program, HEM-POWR, or ongoing single-center studies, developed FVIII inhibitors. Efficacy for perioperative hemostasis has been demonstrated. Low bleeding rates were achieved across the studies, with twice weekly, every 5-day and every 7-day prophylaxis offering patients ≥ 12 years and their clinicians the chance to tailor treatment to individual needs and lifestyles, while maintaining long-term protection from bleeds and their consequences.

News (Medical) associated with Rurioctocog alfa pegol

31 Oct 2023

·www.prnewswire.com

Octapharma AG: Indirect comparison data indicate that personalised prophylaxis with Nuwiq® may lead to fewer patients with haemophilia A having bleeds than with other recombinant factor VIII products

The well-established matching-adjusted indirect comparison (MAIC) methodology was used to compare the efficacy of personalised prophylaxis with Nuwiq® against other recombinant FVIII products Personalised prophylaxis with Nuwiq® can lead to higher rates of patients with zero bleeds compared with other recombinant FVIII products, albeit with higher weekly doses The data were published recently in the European Journal of Haematology LACHEN, Switzerland, Oct. 31, 2023 /PRNewswire/ -- Data from a matching-adjusted indirect comparison (MAIC) of Nuwiq® (simoctocog alfa) versus extended half-life recombinant factor VIII (rFVIII) concentrates in haemophilia A patients undergoing personalised prophylaxis were published in the European Journal of Haematology1. Preliminary data from the MAIC were presented by Dr Craig Kessler, Lombardi Comprehensive Cancer Center and Georgetown University Medical Center, at the 65th ASH Annual Meeting & Exposition in December 20222. Continue Reading Octapharma AG: Indirect comparison data indicate that personalised prophylaxis with Nuwiq® may lead to fewer patients with haemophilia A having bleeds than with other recombinant factor VIII products The analysis used MAIC – a well-established statistical approach – to compare the efficacy of pharmacokinetic (PK)-guided, personalised prophylaxis with Nuwiq® (simoctocog alfa) versus Eloctate® (efmoroctocog alfa), Jivi® (damoctocog alfa pegol), and Adynovate® (rurioctocog alfa pegol). The analysis used data from prospective clinical trials of personalised prophylaxis in adults with severe haemophilia A. Dr Kessler commented, "This MAIC exercise provides important comparative data on the efficacy and consumption of various recombinant FVIII products in adults with haemophilia A on personalised prophylaxis. The results can be considered by clinicians and patients when treatment decisions are being made." MAICs are a way of comparing the efficacy of different medical interventions or products in the absence of head-to-head randomised trials3. By matching patient populations based on clinically relevant baseline characteristics, it reduces inherent differences between the studies and can provide comparative evidence of relative treatment effects. Individual patient data from patients treated with Nuwiq® in the NuPreviq study were compared with aggregated data from 117 patients treated with Eloctate® in the personalised prophylaxis arm of the A-LONG study, 110 patients treated with Jivi® in the PROTECT VIII study, and patients treated with Adynovate® in the PROPEL study (which had two arms targeting different FVIII trough levels: 1–3% (57 patients) and 8–12% (58 patients)). A significantly higher percentage of patients with zero bleeds was reported with Nuwiq® compared with Eloctate® (75% vs 45%), Jivi® (77% vs 38%) or Adynovate® (target trough level 1–3%; 78% vs 42%). The efficacy of Nuwiq® was similar to that of Adynovate® in the 8–12% arm (77% vs 62%). The mean annualised bleeding rate was significantly lower with Nuwiq® than with Jivi® (1.5 vs 4.9). Consistent with the approved dosing, the mean FVIII weekly dose was significantly higher for Nuwiq® than Eloctate®, Jivi® or Adynovate® 1–3%, but lower than for Adynovate® 8–12%. Further details of the study can be found in the European Journal of Haematology publication. In addition, a short video summarising the results is available in the online version of the article. About Octapharma Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centres across Europe and the US. Octapharma has 40 years of experience in patient care. About Nuwiq® Nuwiq® (simoctocog alfa) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in a human cell line without chemical modification or fusion with any other protein4. It is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for von Willebrand factor4. Nuwiq® treatment has been assessed in nine4-6 completed clinical trials which included 201 previously treated patients (190 individuals)4 and 108 previously untreated patients5 with severe haemophilia A. Nuwiq® is available in 250 IU, 500 IU, 1,000 IU, 1,500 IU, 2,000 IU, 2,500 IU, 3,000 IU and 4,000 IU presentations7. Nuwiq® is approved for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency) across all age groups7. References Kessler CM et al. Eur J Haematol 2023; 111:757–67. Kessler CM and Tiede A. Blood 2022; 140(Suppl. 1): 2755–6. Signorovitch JE et al. Value Health 2012; 15:940–7. Lissitchkov T et al. Ther Adv Hematol 2019; 10:2040620719858471. Liesner RJ et al. Thromb Haemost 2021; 121:1400–8. Octapharma AG, data on file. Nuwiq® Summary of Product Characteristics. Logo - Video - SOURCE Octapharma AG

Clinical ResultDrug ApprovalClinical Study

18 Oct 2022

·www.biospace.com

ADARx Pharmaceuticals Further Expands Leadership Team, Appointing Feriandas Greblikas, M.D. as VP of Clinical Development

SAN DIEGO--(BUSINESS WIRE)-- ADARx Pharmaceuticals, Inc., a biotechnology company developing RNA-targeting therapeutics, today announced the further expansion of their leadership team and clinical development capabilities through the appointment of Feriandas Greblikas, M.D. as Vice President of Clinical Development. “We are very excited to have Feriandas join the ADARx team,” said Dr. Zhen Li, President and Chief Executive officer of ADARx. “With his wealth of experience in drug development and clinical execution, he will make significant contributions to ADARx’s strategy, and operational effectiveness as we continue to advance programs to the clinic.” Dr. Greblikas joins ADARx as ADX-324 for the treatment of hereditary angioedema is set to start phase I clinical trials later this year and two additional drug candidates are expected to enter clinical trials next year. Dr. Greblikas is an established physician-scientist with more than 10 years of extensive experience in drug development, medical oversight, clinical trial planning and execution. Prior to joining ADARx, Dr. Greblikas served as a Senior Medical Director at Travere Therapeutics, in which he contributed to the development of pegtibatinase and fosmetpantothenate programs. Prior positions include Medical Director at BioMarin, Baxter and Biogen, and significant contributions to approved drugs Palynziq®, Adynovate® and Eloctate®. Dr. Greblikas received his M.D. in pediatrics from the Vilnius University. Dr. Greblikas also holds an Economics diploma from the International Business School of Vilnius University. “I am delighted to join the passionate team at ADARx and be part of a shared commitment of bringing safe and effective treatments to patients with unmet needs,” said Dr. Greblikas. “The ADARx pipeline presents diverse options for first-in-class and best-in-class drugs to realize this commitment.” About ADARx ADARx Pharmaceuticals, Inc., located in San Diego, is a biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx is developing a proprietary RNA targeting platform, including oligonucleotides for inhibition, degradation, and editing, together with novel oligonucleotide delivery technologies. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated and central nervous system diseases. ADARx lead programs are entering clinical stage.

First in ClassOligonucleotide

05 Feb 2013

·www.biospace.com

Nektar Therapeutics (CA) Announces Initiation of Investigator-Initiated Trial Evaluating Etirinotecan Pegol (NKTR-102) as a Third-Line Treatment in Patients With Metastatic and Recurrent Non-Small Cell Lung Cancer (NSCLC)

SAN FRANCISCO, Feb. 5, 2013 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) announced today the start of a Phase 2 investigator-initiated study of etirinotecan pegol in patients with metastatic and recurrent NSCLC. The study is being conducted at the Abramson Cancer Center of the University of Pennsylvania under the direction of Charu Aggarwal, M.D., M.P.H., Assistant Professor of Oncology and Corey Langer, M.D., Professor of Oncology. "Patients with metastatic or recurrent non-small cell lung cancer currently have no standard treatment options after failure of second-line treatment," said Dr. Aggarwal. "In Phase 1 studies, etirinotecan pegol demonstrated encouraging anti-tumor activity in a broad range of solid tumors including non-small cell lung cancer. We are highly interested in evaluating etirinotecan pegol as a potential treatment option for this patient population." The primary endpoint of the Phase 2 study is overall response rate (ORR). Secondary endpoints include progression free survival (PFS), overall survival (OS), median duration of response (DoR) and the safety pro etirinotecan pegol in patients with NSCLC after failure of second-line therapy. The open label, single-arm trial is expected to enroll approximately 37 patients who will receive etirinotecan pegol once every three weeks as monotherapy. "We are very pleased that Dr. Aggarwal and Dr. Langer have identified and proposed this study of single-agent etirinotecan pegol in patients with this difficult to treat cancer," said Robert Medve, M.D., Senior Vice President and Chief Medical Officer of Nektar Therapeutics. "We are pleased that there has been so much interest in etirinotecan pegol from the oncology community. The results of these studies will provide us with a greater understanding of the potential of etirinotecan pegol to benefit patients in need of new treatment options." About NSCLC Lung cancer is the leading cause of cancer-related mortality in the US with NSCLC accounting for approximately 85% of all lung cancer diagnoses [1]. Most NSCLC patients present with loco-regionally advanced or metastatic disease. Platinum-based chemotherapy is the mainstay of treatment for NSCLC in the first-line setting for metastatic disease. Even after response to first-line therapy, patients eventually develop progressive disease and require additional treatment. Currently, pemetrexed, docetaxel, and erlotinib are the only FDA approved agents in the second line setting. Erlotinib is the only agent approved for use in the third-line setting, however, progression-free survival and overall survival remain suboptimal and there are no cytotoxics formally approved to treat patients in the third-line setting. Consequently, there is a need for new therapies that are safe and effective, which may improve overall survival and quality of life. About Etirinotecan Pegol Etirinotecan pegol is a unique, targeted topoisomerase I inhibitor designed for prolonged tumor cell exposure. Etirinotecan pegol is believed to penetrate the vasculature of the tumor environment more readily than normal vasculature, increasing the concentration of active drug within tumor tissue to enhance anti-tumor activity. The BEACON study is a Phase 3 clinical study currently evaluating etirinotecan pegol for the treatment of locally recurrent or metastatic breast cancer. In addition to metastatic breast cancer, etirinotecan pegol is also being evaluated for the treatment of ovarian, colorectal and glioma cancers. About Nektar Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which is being evaluated in Phase 3 clinical studies as a once- daily, oral tablet for the treatment of opioid-induced constipation. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic candidate for chronic pain conditions, is in Phase 2 development in osteoarthritis patients with chronic knee pain. NKTR-192, a novel mu-opioid analgesic in development to treat acute pain is in Phase 1 clinical development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3 clinical study (the BEACON study) for the treatment of metastatic breast cancer and is also in Phase 2 studies for the treatment of ovarian and colorectal cancers. Nektar's technology has enabled eight approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including Affymax's OMONTYS® for anemia, UCB's Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia. Additional development-stage products that leverage Nektar's proprietary technology platform include Baxter's BAX 855, a long-acting PEGylated rFVIII program, which is in Phase 3 clinical development. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at . Nektar Investor Inquiries: Jennifer Ruddock/Nektar Therapeutics(415) 482-5585 Susan Noonan/SA Noonan Communications, LLC(212) 966-3650 Nektar Media Inquiries: Amanda Connolly/MSL (404) 870-6865 Mike Huckman /MSL (646) 500-7631 1. Siegel, R., D. Naishadham, and A. Jemal, Cancer statistics, 2012. CA Cancer J Clin, 2012. 62(1): p. 10-29. SOURCE Nektar Therapeutics

Collaborate

100 Deals associated with Rurioctocog alfa pegol

External Link

KEGG	Wiki	ATC	Drug Bank
-	Rurioctocog alfa pegol	B02BD02	DB16007

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Coagulation Protein Disorders	JP	Takeda Pharmaceutical Co., Ltd.	05 Dec 2017
Hemophilia A	US	Takeda Pharmaceuticals U.S.A., Inc.	13 Nov 2015

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hemophilia A	Discovery	CN	Takeda (China) International Trading Co. Ltd.	25 Jun 2021
Hemophilia A	Discovery	CN	Baxalta, Inc.	25 Jun 2021
Hemorrhage	Discovery	SE	Baxalta Innovations GmbH	15 Oct 2013
Hemorrhage	Discovery	CZ	Baxalta Innovations GmbH	15 Oct 2013
Hemorrhage	Discovery	KR	Baxalta, Inc.	15 Oct 2013
Hemorrhage	Discovery	MY	Baxalta, Inc.	15 Oct 2013
Hemorrhage	Discovery	RO	Baxalta, Inc.	15 Oct 2013
Hemorrhage	Discovery	AT	Baxalta Innovations GmbH	15 Oct 2013
Hemorrhage	Discovery	RO	Baxalta Innovations GmbH	15 Oct 2013
Hemorrhage	Discovery	IL	Baxalta, Inc.	15 Oct 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05042440 (Phase 1 sequential pharmacokinetic study, EHA2024) Manual	Phase 1	Hemophilia A FVIII	13	Octocog alfa	(wsgdtiskua) = yccdfxvmjt yoxshphgtu (xrlhwthteq ) View more	Positive	14 May 2024
				Rurioctocog alfa pegol	(wsgdtiskua) = pxwnsgrqbk yoxshphgtu (xrlhwthteq ) View more
NCT02615691 (Pubmed)	Phase 3	Hemophilia A	80	Rurioctocog alfa pegol prophylaxis	sklwbqjhvb(jlmtptsnsr) = Thirteen patients experienced 14 treatment-related adverse events, including 10 cases of FVIII inhibitor development cghxuzbjbk (jtivoauxct )	-	03 Oct 2023
NCT04015492 (Pubmed \| Ann Hematol)	Phase 1	Hemophilia A	18	damoctocog alfa pegol	kvpuwckmbe(dexcffeper) = pencysxich rykgkksbhu (idopwbcwop )	-	01 Nov 2020
				rurioctocog alfa pegol	kvpuwckmbe(dexcffeper) = wmtmlrmtfa rykgkksbhu (idopwbcwop )
ISTH2020	Not Applicable	rurioctocog alfa pegol	-	Adynovi®	zlavhjcfbr(lssbqqxmuo) = fducsnzpek ihiiekkeyi (glepqqdbif )	-	12 Jul 2020
				100% Adynovi®	zlavhjcfbr(lssbqqxmuo) = pooqfvsdro ihiiekkeyi (glepqqdbif )
NCT01736475 (PROLONG-ATE, Pubmed) Manual	Phase 2/3	Hemophilia A	10	rurioctocog alfa pegol	(fbnvkpmyem) = vzvgjonulx hmlzgcedor (jlywxzhhxy )	Positive	01 Sep 2019
NCT02585960 (PROPEL, CTgov)	Phase 3	Hemophilia A	135	BAX 855 (BAX 855-Low Level)	hmazsaxdzk(wfqvxtzsht) = kqqcxgtdwq jlbtjacinf (uzcekfpxlu, nxhvifgytg - kkqbcvvgiq) View more	-	26 Aug 2019
				BAX 855 (BAX 855-High Level)	hmazsaxdzk(wfqvxtzsht) = erxrggiged jlbtjacinf (uzcekfpxlu, toxqarrncu - gdblidvhwb) View more
ISTH2019	Not Applicable	Hemophilia A	12	Rurioctocog alfa pegol	dpfzjocsyw(zdvcwoyjlx) = mxqxsouncc oewualgqjo (hbgkcudvmm )	-	10 Jun 2019
NCT01945593 (CONTINUATION, ISTH2019)	Phase 3	Hemophilia A	216	Rurioctocog alfa pegol	syuezglrrp(ahwyrnechm) = a non-serious mild AE that resolved ~3-4 weeks after study end qbhlrwfavk (gamfmoftcn )	-	10 Jun 2019
NCT01945593 (CONTINUATION, CTgov)	Phase 3	Hemorrhage \| Hemophilia A	218	BAX 855 (BAX 855: Age < 2 Years)	tsurckjzdv(aobyyjdrtk) = cksmlrmfkc onzhujvlpv (utfcgxmeqc, qndihmyjgm - fivectaldp) View more	-	01 May 2019
				BAX 855 (BAX 855: Age >= 2 to <12 Years)	tsurckjzdv(aobyyjdrtk) = srzloojcrq onzhujvlpv (utfcgxmeqc, nsdmebnjjn - zzufyjbgsw) View more
NCT01913405 (Pubmed \| Haemophilia) Manual	Phase 3	Hemophilia A	15	pegylated full-length recombinant factor VIII	bhcjmckigo(yiaoubaocn) = mosrvmrrei pemmsbqtjp (ylkwzlefli ) View more	Positive	01 Jul 2016

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis