Working… Menu

Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation (Nabi-HB-SC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00800787
Recruitment Status : Withdrawn (New sponsor's existing product under evaluation for this indication)
First Posted : December 2, 2008
Last Update Posted : January 18, 2016
Information provided by (Responsible Party):
Biotest Pharmaceuticals Corporation

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 transplantation.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Biological: Nabi-HB Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2010
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : September 2010

Arm Intervention/treatment
Experimental: Arm One: Nabi-HB
All subjects will be administered Nabi HB Subcutaneously
Biological: Nabi-HB

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)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate the safety of Nabi-HB administered subcutaneously weekly for a total of 14 weeks. [ Time Frame: 14 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00800787

Sponsors and Collaborators
Biotest Pharmaceuticals Corporation
Layout table for investigator information
Study Director: Shailesh Chavan, MD Sponsor GmbH
Layout table for additonal information
Responsible Party: Biotest Pharmaceuticals Corporation Identifier: NCT00800787    
Other Study ID Numbers: 4210
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: June 2010
Keywords provided by Biotest Pharmaceuticals Corporation:
Chronic hepatitis B liver disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Immunologic Factors
Physiological Effects of Drugs