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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.
 
ClinicalTrials.gov 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Recruitment Status : Withdrawn (New sponsor's existing product under evaluation for this indication)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
Sponsor:
Information provided by (Responsible Party):
Biotest Pharmaceuticals Corporation

Tracking Information
First Submitted Date  ICMJE November 26, 2008
First Posted Date  ICMJE December 2, 2008
Last Update Posted Date January 18, 2016
Study Start Date  ICMJE April 2010
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2008)
To evaluate the safety of Nabi-HB administered subcutaneously weekly for a total of 14 weeks. [ Time Frame: 14 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis B, Chronic
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: Arm One: Nabi-HB
All subjects will be administered Nabi HB Subcutaneously
Intervention: Biological: Nabi-HB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 15, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2008)
25
Estimated Study Completion Date  ICMJE September 2010
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00800787
Other Study ID Numbers  ICMJE 4210
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biotest Pharmaceuticals Corporation
Study Sponsor  ICMJE Biotest Pharmaceuticals Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shailesh Chavan, MD Sponsor GmbH
PRS Account Biotest Pharmaceuticals Corporation
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP