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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00753467
Study type Interventional
Source Huntington Medical Research Institutes
Contact
Status Not yet recruiting
Phase Phase 2
Start date September 2008
Completion date August 2009

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