Status:
WITHDRAWN
Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation
Lead Sponsor:
Biotest Pharmaceuticals Corporation
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 trans...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00800787
Start Date
April 1 2010
End Date
September 1 2010
Last Update
January 18 2016
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