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This study has been withdrawn prior to enrollment.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 (Responsible Party):
Biotest Pharmaceuticals Corporation
First received: November 26, 2008
Last updated: January 15, 2016
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.
Hepatitis B, Chronic
||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 ]
| 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
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
Other Name: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800787
Biotest Pharmaceuticals Corporation
||Shailesh Chavan, MD
||Biotest Pharmaceuticals Corporation
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 26, 2008
||January 15, 2016
||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 22, 2016
Hepatitis B, Chronic
DNA Virus Infections
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Physiological Effects of Drugs