NCT00800787

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biotest Pharmaceuticals Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-08-01
• Completion: 2010-09-01
• First posted: 2008-12-02
• Last updated: 2016-01-18