NCT00753467

A Phase II Study to Determine the Safety and Efficacy of Interferon-gamma in Patients With Chronic Hepatitis B

Protocol Title: A Phase II Open-labeled Study to Determine the Safety and Preliminary Efficacy of Interferon-gamma 1b (IFN-γ 1b) in Patients With Chronic Hepatitis B Who Are HBV DNA Positive

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Huntington Medical Research Institutes · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Open-label, prospective, two part study evaluating IFN-γ 1b at a dose of 200μg by subcutaneous injection every day either alone or in combination with Adefovir dipivoxil or Adefovir dipivoxil alone at a dose of 10mg QD in patients with chronic Hepatitis B.

Detailed description

After signing the informed consent potential patients will undergo a screening medical history, physical examination, and laboratory tests. The study will consist of two parts: * Part A: IFN-γ 1b monotherapy * Part B: IFN-γ 1b combination therapy with Adefovir dipivoxil or Adefovir dipivoxil monotherapy Patients will be enrolled sequentially into to one of three treatment groups. In Part A, ten patients will be enrolled and will receive IFN-γ 1b 200μg, administered every day by subcutaneous injection for 4 weeks. If HBV DNA is reduced by ≥ 1 log10 copies/ mL in ≥ 30% of patients the protocol will proceed to Part B. In Part B, twenty patients will be enrolled into two cohorts (total of 10 for each cohort) and treated for four weeks. The two cohorts will be administered: * IFN-γ 1b 200μg, administered every day combination therapy with Adefovir dipivoxil (10mg QD) or * Adefovir dipivoxil (10mg QD) alone On the initial study visit, patients will be given instruction on self injection of IFN-γ 1b (if applicable). Patients will be monitored for safety, tolerability, HBV DNA, clinical chemistries including a standard panel of liver tests and hematologies throughout the study and for the two week post-treatment observation period.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	IFN-γ 1b (Actimmune)	IFN-γ 1b: 200μg given SC ED = 2 vials of active drug (0.5 mL from each vial) will be mixed for a total volume of 1.0 mL per dose
DRUG	Adefovir dipivoxil	Adefovir dipivoxil: 1 tablet of 10mg given orally QD
DRUG	IFN-γ 1b and Adefovir dipivoxil combination	IFN-γ 1b: 200μg given SC ED = 2 vials of active drug (0.5 mL from each vial) will be mixed for a total volume of 1.0 mL per dose Adefovir dipivoxil: 1 tablet of 10mg given orally QD

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-09-16
• Last updated: 2010-10-21

Locations

1 site across 1 country: United States