Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation
Information source: Biotest Pharmaceuticals Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B Liver Disease; Orthostotic Liver Transplant
Intervention: Hepatitis B immune globulin (Human) (Biological)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Biotest Pharmaceuticals Corporation
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 transplantation.
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: To evaluate the safety of Nabi-HB administered subcutaneously weekly for a total of 14 weeks.
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: April 2010
Last updated: June 29, 2010
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