Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation (Nabi-HB-SC)
This study has been withdrawn prior to enrollment.
(New sponsor's existing product under evaluation for this indication)
Information provided by:
Biotest Pharmaceuticals Corporation
First received: November 26, 2008
Last updated: June 29, 2010
Last verified: June 2010
A phase 3, multicenter, open label study to assess the safety and efficacy of Nabi-HB, administered subcutaneously in patients with Hepatitis B Virus Associated Liver Disease who underwent liver transplantation.
Chronic Hepatitis B Liver Disease
Orthostotic Liver Transplant
Biological: Hepatitis B immune globulin (Human)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 3, Multicenter, Open Label Study to Assess the Safety and Efficacy of Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Associated Liver Disease Who Underwent Liver Transplantation
Primary Outcome Measures:
- To evaluate the efficacy of Nabi-HB administered subcutaneously weekly for a total of 14 weeks in patients who previously underwent a liver transplant. Levels will provide evidence if effective anti-HB levels >150 IU/ML can be maintained. [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the safety of Nabi-HB administered subcutaneously weekly for a total of 14 weeks. [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2010 (Final data collection date for primary outcome measure)
Experimental: Arm One: Nabi-HB
All subjects will be administered Nabi HB Subcutaneously
Biological: Hepatitis B immune globulin (Human)
Hepatitis b Immune Globulin (Human)(Nabi-HB) 312 IU/L per dose administered subcutaneously.
Dosage will be according to each patients body weight, as follow:
< 75 kg: 500 IU weekly ( may be increase to 1,000 IU weekly if anti-HBs levels are <150 IU/ML > 75 Kg: 1,000 IU weekly
- Hepatitis B Immune Globulin (Human)
This is a phase 3 prospective, single arm open label study to be conducted t approximately 4 study sited located in th e USA. Approximately 25 HBV DNA negative patients who underwent liver transplant at least one year prior, due to chronic hepatitis B infection will bwe eligible for study participation. The study consist of a total of 16 study visit and the duration of participation will be 20 weeks for each patients. Patients will be converted from the intravenous standard HBIG to Nabi-HB subcutaneous administration according to the individual scheduled dosing interval.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male or female patients 18 years old or older as of visit one.
- If female is not trying to conserve, not lactating, and has a negative serum pregnancy test and use an acceptable method of contraception or be at least one year post-menopausal or surgically sterile.
- Able to provide written informed consent.
- First time liver transplant recipient.
- Primary, single organ recipient (deceased donor <65 years old).
- receive regular long-term HBIG prophylaxis with stabilized HBIG dosage and administration intervals.
- Have negative quantifiable HBV-DNA and HBsAg results prior to dosing at visit 2.
- Following the last IV administration of HBIG, have a baseline serum anti-HBs level of >150 IU/ML prior to dosing at visit 2.
- Positive HCV or HIV test results.
- Unexplained elevated liver function tests.
- Serum creatinine level >2.0 times the upper limit of normal.
- life expectancy <6 months.
- liver transplantation with ongoing acute rejection episode. Donor liver that was from a hepatitis Bor C positive donor. Underwent a liver transplant <12 months prior to visit 1.
- Know history of cancer, suspected cancer, or cancer therapy within 12 months.
- History of autoimmune disease.
- History/current evidence of coagulation disorder, severe cardiac disease, unhealed gastric or duodenal ulcer, or other significant disease.
- Evidence of any other unresolved infection and any unresolved opportunistic infection requiring treatment.
- Known immunoglobulin A deficiency.
- History of use of immunosupressive or immunomodulatory drug within 3 month prior to visit 1. (except low dose glucocorticoid therapy, <10 mg of prednisone or equivalent per day.)
- received and investigational drug 30 days prior to visit 1.
- use of plasma preparations or other immunoglobulins during the study.
- Know intolerance to proteins of human origin, immunoglobulin, or comparable products.
- Evidence of alcohol and/or drug abuse within 6 month of visit 2 or inability/unwillingness to abstain from alcohol for the duration of the study.
No Contacts or Locations Provided
No publications provided
||George L. Herrera, MD, Biotest Pharmaceuticals Corporation
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 26, 2008
||June 29, 2010
||United States: Food and Drug Administration
Keywords provided by Biotest Pharmaceuticals Corporation:
Chronic hepatitis B liver disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Hepatitis B, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
DNA Virus Infections
Physiological Effects of Drugs