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

NCT00800787 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-01-18

No results posted yet for this study

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.

Conditions

  • Hepatitis B, Chronic

Interventions

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

Sponsors & Collaborators

  • Biotest Pharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Shailesh Chavan, MD · Sponsor GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-08-31
Completion
2010-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00800787 on ClinicalTrials.gov