A randomized, open, parallel controlled, single-center clinical trial for recombinant human erythropoietin injection (CHO cells) in the treatment of anemia caused by chemotherapy in non-bone marrow malignant tumors at different times

Start Date01 Aug 2019

Sponsor / Collaborator-

ChiCTR1800014265 / SuspendedPhase 4IIT

A Randomized, controlled, open multicenter clinical trial of Recombinant Human Erythropoietin Injection (CHO cells) comparing for single and two to three times weekly administration of renal anemia in maintenance hemodialysis

Start Date19 Jan 2018

Sponsor / Collaborator-

100 Clinical Results associated with Epoetin alfa biosimilar (LG Life Sciences)

100 Translational Medicine associated with Epoetin alfa biosimilar (LG Life Sciences)

100 Patents (Medical) associated with Epoetin alfa biosimilar (LG Life Sciences)

Literatures (Medical) associated with Epoetin alfa biosimilar (LG Life Sciences)

01 May 2009·Clinical TherapeuticsQ4 · MEDICINE

Pharmacokinetic, tolerability, and bioequivalence comparison of three different intravenous formulations of recombinant human erythropoietin in healthy Korean adult male volunteers: An open-label, randomized-sequence, three-treatment, three-way crossover study

Q4 · MEDICINE

Article

Author: Jong Lyul Ghim ; Jin Ah Jung ; Un Jib Kim ; Kyun Seop Bae ; Sang Heon Cho ; Sangmin Choe ; Hyeong Seok Lim

BACKGROUNDExisting formulations of recombinant human erythropoietin (rhEPO) in Korea contain human serum albumin. To avoid the potential risk of infection by human serum albumin, a new albumin-free rhEPO has been developed.OBJECTIVEThis study was conducted to characterize and compare the pharmacokinetic and safety profiles and the bioequivalence of a newly developed albumin-free rhEPO (Aropotin [TS Corporation, Seoul, South Korea]) with 2 existing rhEPO formulations (Espogen [LG Life Sciences, Seoul, South Korea]; Recormon [Roche, Basel, Switzerland]) with albumin in healthy Korean subjects.METHODSThis was an open-label, randomized-sequence, 3-treatment, 3-way crossover study in which healthy, nonobese (+/-20% of ideal weight), male volunteers between the ages of 19 and 50 years were assigned to 1 of 2 dose levels (50 IU/kg or 100 IU/kg) of 3 formulations. Blood was collected over 32 hours and plasma rhEPO concentrations were determined using a validated enzyme immunoassay. There was a 14-day washout between periods. The pharmacokinetic parameters of the 3 formulations were compared using the bioequivalence criteria of the US Food and Drug Administration, which requires that the 90% CIs of the geometric mean ratios for AUC(0-t), AUC(0-infinity), and C(max) fall within 0.80 to 1.25. Tolerability was evaluated by physical examination with measurements of vital signs, clinical laboratory tests, and electrocardiogram. Subjects were followed up for 2 weeks after the last administration of study drug.RESULTSTwelve Korean male volunteers were enrolled and completed the study. Six subjects (mean [SD] age, 22.0 [1.7] years; weight, 63.3 [6.2] kg; height, 172.3 [3.5] cm) received a single 50 IU/kg IV bolus dose of study drug and the remaining 6 subjects (mean [SD] age, 23.7 [1.5] years; weight, 66.3 [4.8] kg; height, 174 [4.7] cm) received 100 IU/kg. After a single 50 IU/kg dose, the geometric mean ratio (90% CI) for Aropotin/Espogen was 1.04 (0.91-1.19) IU/L/h for AUC(0-t) and 1.02 (0.89-1.17) IU/L for C(max). The geometric mean ratio (90% CI) for Aropotin/Recormon was 1.01 (0.88-1.15) IU/L/h for AUC(0-t) and 1.01 (0.89-1.16) IU/L for C(max). After a single 100-IU/kg dose, the geometric mean ratio (90% CI) for Aropotin/ Espogen was 0.98 (0.86-1.13) IU/L/h for AUC(0-t) and 0.99 (0.87-1.13) IU/L for C(max). The geometric mean ratio (90% CI) for Aropotin/Recormon was 0.99 (0.861.14) IU/L/h for AUC(0-t) and 0.96 (0.84-1.10) IU/L for C(max). The most frequent adverse events (AEs) were 3 occurrences of elevated serum creatine phosphokinase and serum lactate dehydrogenase levels in the Recormon 100-IU/kg group (n = 3), 3 events of elevated serum lactate dehydrogenase levels in the Espogen 100-IU/kg group (n = 3), and 4 events of elevated serum total bilirubin levels in the Aropotin 100-IU/kg group (n = 3). All formulations were well tolerated with no serious AEs.CONCLUSIONThe new formulation of rhEPO met the regulatory criteria for bioequivalence in these healthy Korean adult male volunteers. All formulations were generally well tolerated.

01 Apr 2007·Journal of the Medical Association of Thailand = Chotmaihet thangphaet

12-week clinical effects of erythropoietin espogen in end stage renal patients undergoing hemodialysis.

Article

Author: Thitiarchakul, Supachai ; Tasanarong, Adis

BACKGROUNDAnemia is one of most common complications in end stage renal disease (ESRD) patients. Erythropoietin has been recommended for treatment of anemia in these patients.OBJECTIVESTo evaluate the clinical efficacy, safety and usefulness of newly imported erythropoietin, called Espogen, usage in ESRD undergoing hemodialysis.MATERIAL AND METHODAn open, non-comparative, prospective study of administered Espogen was conducted in 30 ESRD patients undergoing hemodialysis for a 12 week period. Eligible criteria included hemoglobin of less than 8 g%, hematocrit of less than 25% for at least three consecutive months with a serum ferritin of more than 100 ng%. Initial dose of drug was 150 units/kg/week subcutaneously, two or three times a week and dosage was adjusted to maintain the Hb at 10-12g%.RESULTSIn 28 patients, hemoglobin and hematocrit were increased significantly from 7.1 +/- 1.14 g/dl and 22.1 +/- 3.24% at baseline to 10.1 +/- 1.49 g/dl and 31.7 +/- 4.01% at the end of the study period respectively (p < 0.05). Mean weekly of Espogen dosage was 8390 +/- 2452.7 IU/week, which was 152.1 IU/kg/week. Some patients could reduce the dose at week 10. Reticulocyte increased significantly from 0.69 +/- 0.58% at baseline to highest value, 1.41 +/- 0.74 at 2 week and 1.30 +/- 0.66 at the end of the present study. Serum vitamin B12, serum folate, and red blood cell folate were not significantly changed. However serum ferritin decreased significantly from 840.6 +/- 948.95 to 582.7 +/- 990.70 ng/ml (p < 0.05). General condition including SF-36 score and tiredness were improved. There were no significant adverse events except mean arterial blood pressure of pre dialysis value which was statistically significant increased at the end of the present study (from 101.0 +/- 17.65 at week 0 and 110.4 +/- 16.8 mmHg at week 12, p = 0.0223).CONCLUSIONThis clinical study showed that Espogen has proven effective and safe for treatment of anemia in hemodialysis patients. No serious adverse events occurred during the study period.

100 Deals associated with Epoetin alfa biosimilar (LG Life Sciences)

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Indication	Country/Location	Organization	Date
Anemia	CN	LG Life Sciences Ltd.	31 May 2009

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2015	Not Applicable	Myelodysplastic Syndromes	107	ERYTHROPOIETIN (No support)	(cpgdnjlfyg) = olpyrlqtzs hescajubhy (pwtcuptcac ) View more	-	21 May 2015
				Epo support	(cpgdnjlfyg) = rmrqdmnrbw hescajubhy (pwtcuptcac ) View more
AUO-AP/33/02 (ASCO2015)	Phase 2	Metastatic castration-resistant prostate cancer	139	DOC + EMP + EPO	(otvzbbrvgm) = fwaeidpdac wdnuswvmeb (zimdyqazje ) View more	-	20 May 2015
				DOC + EMP	(otvzbbrvgm) = xjfwexcgrs wdnuswvmeb (zimdyqazje ) View more
EPO/AMI-1 (Pubmed \| Circ J)	Not Applicable	Acute myocardial infarction	-	EPO	(astiwbejvl) = elpfolgran cqfdmzrrqa (wjwjcsxidw )	Positive	01 Jul 2010
ASCO2008	Not Applicable	Anemia \| Myelodysplastic Syndromes	-	EPO Monotherapy	ohfetthqon(tfpfhhnqoa) = qtgjzjzauj kxqezeyrnv (vzucvbvskh, 49 - 57) View more	-	20 May 2008
				EPO+G/GM-CSF	ohfetthqon(tfpfhhnqoa) = zppmmsgpfv kxqezeyrnv (vzucvbvskh, 43 - 59) View more
ASCO2005	Not Applicable	Cardiomyopathies	-	EPO	holwdgmqrh(sbenjcgsfc) = wyjwdoglpk nkxhroomss (xxsckioosq ) View more	-	01 Jun 2005
Study N02C2 (ASCO2005)	Phase 3	Anemia \| Neoplasms	365	40,000U EPO SC every week	bfmofcrwpl(dmtwadijap) = There was a slight trend towards superior survival in the 120K arm uhmjroehcb (qzepxydzyf )	Positive	01 Jun 2005
				120,000U EPO SC every 3 weeks
ASCO2005	Phase 2	Metastatic Solid Tumor	34	EPO+Dexa	etvocrfiol(qusdrnezba) = rjcptbxvff xrthzuvobk (idhylfysia ) View more	-	01 Jun 2005
ASCO2004	Phase 2	Metastatic Renal Cell Carcinoma	25	Thalidomide	kbqifvfcam(rybbdqjsuj) = ujhgynxbiy yjkjvfstrv (rusuiigezf ) View more	-	15 Jul 2004
				Thalidomide + EPO	kbqifvfcam(rybbdqjsuj) = fhxrpgdaaw yjkjvfstrv (rusuiigezf ) View more

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