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

Hepatitis B, Chronic Clinical Trial

— Nabi-HB-SC  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00800787
• Other study ID #: 4210
• Status: Withdrawn
• Phase: Phase 3
• First received: November 26, 2008
• Last updated: January 15, 2016
• Start date: April 2010
• Est. completion date: September 2010

Study information

• Verified date: June 2010
• Source: Biotest Pharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biotest Pharmaceuticals Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		14 weeks	Yes
Secondary	To evaluate the safety of Nabi-HB administered subcutaneously weekly for a total of 14 weeks.		14 weeks	Yes