Hepatitis B immune globulin
- Generic Name
- Hepatitis B immune globulin
- Brand Names
- Hepagam B, Hyperhep B, Nabi-HB, Zutectra
- Drug Type
- Biotech
- Unique Ingredient Identifier
- XII270YC6M
- Background
Long-term hepatitis B immune globulin (HBIG) has been shown to reduce hepatitis B virus (HBV) reinfection in patients transplanted for hepatitis B. Infection with hepatitis B may lead to hepatocellular carcinoma, a type of liver cancer. Therefore, the hepatitis-B vaccines are cancer-preventing vaccines. According to the Centers for Disease Control and Prevention (CDC), the hepatitis B vaccine was the first anti-cancer vaccine.
HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen. It is extracted from the Cohn fraction II. During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed. The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus.
- Indication
Investigated for use/treatment in hepatitis (viral, B), liver transplant surgery, and pediatric indications.
- Associated Conditions
- Reactivation of hepatitis B virus infection
- Associated Therapies
- Post-exposure prophylaxis of hepatitis B
A Clinical Trial of Zutectra in Patients Who Recently Received a Liver Transplant
- First Posted Date
- 2013-05-17
- Last Posted Date
- 2015-03-25
- Lead Sponsor
- Biotest
- Target Recruit Count
- 49
- Registration Number
- NCT01856413
- Locations
- 🇮🇹
Azienda Ospedaliera Ospedale Niguarda Ca Granda-Chirurgia, Milano, Italy
🇮🇹Liver and Multivisceral Transplant Center, University of Modena and Reggio Emilia, Modena, Italy
🇫🇷Hôpital Paul Brousse, Villejuif, France
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
- First Posted Date
- 2012-01-20
- Last Posted Date
- 2015-06-01
- Lead Sponsor
- SK Chemicals Co., Ltd.
- Target Recruit Count
- 87
- Registration Number
- NCT01513850
- Locations
- 🇰🇷
SKChemicals, Seongnam, Gyunggi-do, Korea, Republic of
Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients
- Conditions
- Hepatitis BLiver Transplantation
- Interventions
- First Posted Date
- 2010-05-26
- Last Posted Date
- 2016-02-25
- Lead Sponsor
- Instituto Grifols, S.A.
- Target Recruit Count
- 15
- Registration Number
- NCT01131065
- Locations
- 🇮🇹
Az. Ospedaliera Universitaria di Padova, Padova, Italy
🇮🇹A.O.U. Policlinico Università di Modena e Reggio Emilia, Modena, Italy
🇮🇹Az. Ospedaliera S.Giovanni Battista di Torino, Torino, Italy
Drug Development Updates
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