Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation - Full Text View

Sponsor:	Biotest Pharmaceuticals Corporation
Information provided by:	Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:	NCT00800787

Purpose

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	Intervention	Phase
Chronic Hepatitis B Liver Disease Orthostotic Liver Transplant	Biological: Hepatitis B immune globulin (Human)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B Liver Diseases Liver Transplantation

Drug Information available for: Immunoglobulins Recombinant hepatitis B vaccine Hepatitis B hyperimmune globulin Hepatitis B Vaccines Hepatitis A Vaccines Globulin, Immune

U.S. FDA Resources

Further study details as provided by Biotest Pharmaceuticals Corporation:

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 ]

Estimated Enrollment:	25
Study Start Date:	April 2010
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm One: Nabi-HB All subjects will be administered Nabi HB Subcutaneously	Biological: Hepatitis B immune globulin (Human) 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 Names: Hepatitis B Immune Globulin (Human) Nabi-HB

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	George L. Herrera, MD, Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:	NCT00800787 History of Changes
Other Study ID Numbers:	4210
Study First Received:	November 26, 2008
Last Updated:	June 29, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biotest Pharmaceuticals Corporation:

Chronic hepatitis B liver disease

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Liver Diseases
Hepatitis B, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections

Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012