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| Sponsor: | Huntington Medical Research Institutes |
|---|---|
| Collaborator: |
InterMune |
| Information provided by: | Huntington Medical Research Institutes |
| ClinicalTrials.gov Identifier: | NCT00753467 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Drug: IFN-γ 1b (Actimmune) Drug: Adefovir dipivoxil Drug: IFN-γ 1b and Adefovir dipivoxil combination |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
IFN-γ 1b monotherapy: 200 micro-grams daily for 30 days
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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
|
|
2: Experimental
IFN-γ 1b 200 micro-grams daily) combination therapy with Adefovir dipivoxil (10 mg daily) for 30 days
|
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
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3: Active Comparator
Adefovir dipivoxil monotherapy (10 mg QD) 30 days
|
Drug: Adefovir dipivoxil
Adefovir dipivoxil: 1 tablet of 10mg given orally QD
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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:
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:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must fulfill all of the following criteria to be eligible for enrollment into the study:
Exclusion Criteria:
Patients with any of the following will be excluded from randomization:
Behavior that suggests a significant risk of poor compliance including, but not limited to:
History of unstable or deteriorating cardiac disease, including but not limited to:
History of (within last two years) or current neurologic or psychiatric disorder that, in the opinion of the site PI, might be exacerbated by flu-like symptoms associated with the administration of IFN γ 1b. In addition, patients with the following conditions should be excluded:
Contacts and Locations| United States, California | |
| Huntington Medical Research Institutes | |
| Pasadena, California, United States, 91105 | |
| Study Chair: | Myron J Tong, Phd, MD | HMRI |
More Information
| Responsible Party: | HMRI ( Myron Tong, PhD, MD ) |
| Study ID Numbers: | TONG-HBV-0801 |
| Study First Received: | September 15, 2008 |
| Last Updated: | September 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00753467 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HBV Treatment Interferon-gamma combination |
Hepsera Actimmune HBV DNA |
|
Anti-Infective Agents Liver Diseases Interferon Type II Hepatitis, Chronic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hepatitis, Viral, Human Hepadnaviridae Infections Reverse Transcriptase Inhibitors Anti-Retroviral Agents Hepatitis B, Chronic Therapeutic Uses Hepatitis B |
Nucleic Acid Synthesis Inhibitors Interferons Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases DNA Virus Infections Adefovir dipivoxil Adefovir Interferon-gamma, Recombinant |