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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 up to 5 years
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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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
472 Total Patients Enrolled
Myron J Tong, Phd, MDStudy ChairHMRI
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