Delving into the Latest Updates on Human hepatitis B immunoglobulin(Biotest Pharma GmbH) with Synapse

Overview

Basic Info

Drug Type

Immunoglobulin

Synonyms

Fovepta, HBVIg - Biotest AG, Hepatect

+ [6]

Target

L-HBsAg

Action

inhibitors, modulators

Mechanism

L-HBsAg inhibitors(L-HBsAg inhibitors), Immunomodulators

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis BHepatitis B, Chronic

Inactive Indication-

Originator Organization

Biotest Pharma GmbH

Active Organization

Biotest Pharma GmbH

Biotest AG

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

European Union (30 Nov 2009),

Hepatitis B

Regulation-

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This is an open-label, single arm (two cohorts), single-center, phase II pilot-study to provide preliminary evidence whether hepatitis B immunoglobulins (HBIG) are efficacious and can be safely used in patients with chronic Hepatitis B Virus (HBV) infection.
A total of 20 patients (male or female adults aged ≥ 18 years) will be enrolled in the study and receive hepatitis B immunoglobulins Hepatect®CP and Zutectra®.

Start Date15 Aug 2022

Sponsor / Collaborator

Hannover Medical School

[+1]

NCT01856413

/ CompletedPhase 3

An Open, Prospective, Single Arm Study Investigating Efficacy and Safety of Human Hepatitis B Immunoglobulin Zutectra in Liver Transplanted Patients - the ZEUS Study

Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure require longterm therapy to prevent HBV reinfection of the transplanted liver. The approved preventative treatment is a combination of antihepatitis B immunoglobulin (HBIg) and oral antiviral medication. In the first 6 months after liver transplantation, patients receive treatment with intravenous HBIg to maintain blood antihepatitis B (antiHBs)antibody concentrations above 100 IU/L, the level considered safe for preventing hepatitis B reinfection.
Zutectra is an HBIg preparation for subcutaneous injection that is approved in the EU for the 'prevention of HBV reinfection in HBV DNA negative patients ≥ 6 months after liver transplantation for hepatitis B induced liver failure'. The purpose of this study is to show that earlier subcutaneous HBIg treatment with Zutectra after liver transplantation can prevent hepatitis B reinfection.
Treatment with subcutaneous HBIg (Zutectra) at home is manageable for the majority of patients and is more convenient for patients compared to intravenous treatment that must take place in the hospital setting.
Fourty patients will take part in the study at approximately 19 centres in UK, France, Italy and Spain. Patients who are eligible for the study will receive treatment with Zutectra for 24 weeks.
During the study, the safety and effectiveness of Zutectra will be assessed by checking for symptoms of hepatitis B related infection, as well as monitoring blood levels of antiHBs antibodies and hepatitis B surface antigen (HBsAg).

Start Date01 Dec 2012

Sponsor / Collaborator

Biotest AG

[+1]

100 Clinical Results associated with Human hepatitis B immunoglobulin(Biotest Pharma GmbH)

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100 Translational Medicine associated with Human hepatitis B immunoglobulin(Biotest Pharma GmbH)

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100 Patents (Medical) associated with Human hepatitis B immunoglobulin(Biotest Pharma GmbH)

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8

Literatures (Medical) associated with Human hepatitis B immunoglobulin(Biotest Pharma GmbH)

01 Mar 2014·International ImmunopharmacologyQ2 · MEDICINE

T-cell inhibitory capacity of hyperimmunoglobulins is influenced by the production process

Q2 · MEDICINE

Article

Author: Mancham, Shanta ; Tjon, Angela S W ; Kwekkeboom, Jaap ; van Gent, Rogier ; Jaadar, Haziz

Intravenous immunoglobulin (IVIg) preparations are widely used for anti-inflammatory therapy of autoimmune and systemic inflammatory diseases. Hyperimmunoglobulins enriched in neutralizing antibodies against viruses can, in addition to their virus-neutralizing activity, also exert immunomodulatory activity. Previously, we observed that Cytotect®, an anti-CMV hyperimmunoglobulin, was less effective in suppressing human T-cell responses in vitro compared to Hepatect® CP, an anti-HBV hyperimmunoglobulin. We hypothesized that the poor immunomodulatory activity of Cytotect® results from treatment with β-propiolactone during the manufacturing process. The manufacturer of these hyperimmunoglobulins has now introduced a new anti-CMV hyperimmunoglobulin, called Cytotect® CP, in which β-propiolactone treatment is omitted. Here we show that Cytotect® CP inhibits PHA-driven T-cell proliferation and cytokine production with similar efficacy as Hepatect® CP, whereas the former Cytotect® does not. In addition, Cytotect® CP inhibits allogeneic T-cell responses better than Cytotect®. Our results advocate the use of hyperimmunoglobulins that have not been exposed to β-propiolactone in order to benefit from their immunomodulatory properties.

01 Jun 2012·Journal of Perinatal MedicineQ4 · MEDICINE

An open-label, randomized efficacy and safety trial of subcutaneous and intramuscular BT088 (Fovepta) human hepatitis B immunoglobulin in neonates of HBV-carrier mothers

Q4 · MEDICINE

Article

Author: Mendling, Werner ; Krivan, Gergely ; Buxmann, Horst ; Wolf, Daniele M. ; Wartenberg-Demand, Andrea ; Schloesser, Rolf L. ; Siklos, Pal ; Kamin, Wolfgang

AbstractObjective: The objective of the study was to assess the efficacy and safety of subcutaneously (SC) and intramuscularly (IM) administered BT088 (Fovepta) human hepatitis B immunoglobulin in neonates of hepatitis B surface antigen (HBs/HBsAg)-positive mothers in the prevention of hepatitis B infection.Methods: This was an open, prospective, multicenter trial, in which infants were randomized to receive a single SC or IM dose of BT088 (200 IU, 0.4 mL) within 12 h of birth simultaneously with active vaccination against hepatitis B. The primary efficacy variable was the response rate, defined as the proportion of infants whose anti-HBs concentration was negative at predose and ≥100 IU/L 48 to 72 h postdose.Results: The full analysis set included 31 neonates (17 SC and 14 IM). Response was experienced by 30 (96.8%) of 31 infants who received BT088 by either route of administration. The median postdose anti-HBs concentration was 261.2 IU/L. One neonate had a postdose anti-HBs level lower than 100 IU/L (81.0 IU/L). No infant experienced seroconversion during the 7- to 15-month follow-up. BT088 was well tolerated, with no allergic-like, or injection-site reactions observed.Conclusion: SC and IM administration of 200 IU (0.4 mL) BT088 resulted in protective serum anti-HBs titers within 72 h of administration in newborn infants and was well tolerated and effective.

01 May 2011·Transplant InternationalQ2 · MEDICINE

Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in liver transplantation: an open, prospective, single-arm phase III study

Q2 · MEDICINE

Article

Author: Christian Klein ; Susanne Beckebaum ; Ruth Neuhaus ; Vito Cicinnati ; Andreas Pascher ; Ali Yahyazadeh ; Andreas Paul

Hepatitis B re-infection prophylaxis is crucial for graft and recipient survival for transplanted patients and is administered routinely after liver transplantation for hepatitis B. Aim of the current study was the investigation of efficacy, safety and feasibility of home-treatment of a novel human hepatitis B immunoglobulin BT088 (Zutectra) after weekly subcutaneous application in liver-transplanted patients. A total of 23 patients (5 female, 18 male, median age 51 years) were enrolled and switched from monthly IV to weekly SC hepatitis B immunoglobulin administration. During a period of 18 weeks (optional 24 weeks) anti-HBs levels, signs of re-infection, adverse events and feasibility of self-administration were studied. After 8 weeks of training patients showing good compliance and stable antibody titres were allowed to start self-administration at home. All patients maintained a safety level of >100 U/l anti-HBs. No failure was noted, no re-infection occurred. A total of 10 treatment-emergent events were assessed as related to study drug application (injection-site haematoma, headache, abdominal pain, fatigue and haematuria). High numbers of self-administration (287 vs. 122 by staff) demonstrated general feasibility of SC administration. Weekly subcutaneous administration of BT088 (Zutectra - registered trade mark in the EU) is effective, safe and presents an easy-to-apply treatment option for combined hepatitis B virus re-infection prophylaxis in liver transplant patients (Eudra CT Number: 2005-003737-40).

100 Deals associated with Human hepatitis B immunoglobulin(Biotest Pharma GmbH)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis B	Liechtenstein	Biotest Pharma GmbH	30 Nov 2009
Hepatitis B	Norway	Biotest Pharma GmbH	30 Nov 2009
Hepatitis B	Iceland	Biotest Pharma GmbH	30 Nov 2009
Hepatitis B	European Union	Biotest Pharma GmbH	30 Nov 2009

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B, Chronic	Phase 2	Germany	Biotest AG	15 Aug 2022

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