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Cytokine

1 for Hepatitis B

Phase 2
Waitlist Available
Research Sponsored by Huntington Medical Research Institutes
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study 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.

Eligible Conditions
  • Hepatitis B

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary objective is to evaluate the safety and tolerability of IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.
Secondary outcome measures
Evaluate the changes in liver tests and hematology following administration of Adefovir dipivoxil alone, IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.
Evaluate the changes in serum HBV DNA concentrations following administration of Adefovir dipivoxil alone, IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: 2Experimental Treatment1 Intervention
IFN-γ 1b 200 micro-grams daily) combination therapy with Adefovir dipivoxil (10 mg daily) for 30 days
Group II: 1Experimental Treatment1 Intervention
IFN-γ 1b monotherapy: 200 micro-grams daily for 30 days
Group III: 3Active Control1 Intervention
Adefovir dipivoxil monotherapy (10 mg QD) 30 days

Find a Location

Who is running the clinical trial?

InterMuneIndustry Sponsor
22 Previous Clinical Trials
3,786 Total Patients Enrolled
Huntington Medical Research InstitutesLead Sponsor
5 Previous Clinical Trials
475 Total Patients Enrolled
Myron J Tong, Phd, MDStudy ChairHMRI

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase II Study to Determine the Safety and Efficacy of Interferon-gamma in Patients With Chronic Hepatitis B
2008. "A Phase II Study to Determine the Safety and Efficacy of Interferon-gamma in Patients With Chronic Hepatitis B". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00753467.
All > Autoimmune Hepatitis > Hepatitis B
~2 spots leftby Apr 2025
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