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

Status unconfirmed · Phase 2

Conditions studied: Hepatitis B

In brief

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.

Key facts

Study ID

NCT00753467

Run by

Huntington Medical Research Institutes

People needed

30

Starts

2008-09-01

Expected to finish

2009-08-01

Last updated by the study team

2010-10-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must fulfill all of the following criteria to be eligible for enrollment into the study:
• Men or women age 18 to 75 years
• Chronic hepatitis B infection based on a history of positive anti-HBsAg and positive for HBV DNA and with or without elevations in liver tests (test to be repeated on screening)

You may not qualify if…

• Patients with any of the following will be excluded from randomization:
• Presence of clinically evident cirrhosis including: ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of GI variceal bleeding
• Platelet count < 50,000/mm3
• Serum ALT level > 10 times upper limit of normal
• Alpha-fetoprotein level ≥ 200 ng/mL or alpha-fetoprotein level between 50-200 ng/mL in association with liver ultrasound or other radiographic abnormality suspicious for hepatic neoplasm
• Serum creatinine level > 1.6 mg/dL
• Hematology outside of specified limits: neutrophil count <1000/mm3, hemoglobin <10 g/dL in males and <9 g/dL in females
• Unstable or uncontrolled thyroid disease
• Treatment with any interferon-α or nucleoside/tide analog within the previous 4 weeks
• Presence of clinically significant cryoglobulinemia (e.g., skin rash, arthritis, or renal insufficiency due to cryoglobuliemia)
• Presence or history of autoimmune hepatitis, alpha-1 anti-trypsin deficiency, hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, or sclerosing cholangitis (mild-to-moderate steatosis is acceptable)
• Chronic hepatitis C infection
• Hepatits Delta infection (HDV)
• Known history of HIV infection or positive HIV antibody test by Western Blot (test performed within 60 days of screening can be used to determine eligibility)
• A disease known to cause significant alteration in immunologic function including hematological malignancy or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus erythematosis, autoimmune thyroid disease, leukemia, lymphoma, etc)
• Concurrent therapy with immunosuppressive drugs or cytotoxic agents such as oral prednisone, cyclosporine, azathioprine, or chemotherapeutic agent(s) (e.g., cyclophosphamide, methotrexate, or cancer chemotherapy) or radiation therapy
• Behavior that suggests a significant risk of poor compliance including, but not limited to:
• Illicit drug abuse within the past 3 years
• Current or history of alcohol abuse within the past 2 years
• Prior treatment with IFN-γ 1b
• History of unstable or deteriorating cardiac disease, including but not limited to:
• Myocardial infarction, coronary artery bypass surgery, or angioplasty within the past 6 months
• Congestive heart failure requiring hospitalization within the past 6 months
• Uncontrolled arrhythmias
• Transient ischemic attacks (TIAs)

Where it is running

• Huntington Medical Research Institutes — Pasadena, California, United States

Full record on ClinicalTrials.gov

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