Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With CHC

Completed · Phase 4

Conditions studied: Hepatitis C

In brief

The purpose of this study is to see which of two doses of PEG (polyethylene glycol) interferon alfa-2b in combination with Ribavirin for 48 weeks is more effective at elimination of hepatitis C. The primary objective of this study is to compare the efficacy of Induction PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) to standard PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) in patients with chronic hepatitis C.

Key facts

Study ID

NCT00207363

Run by

Brooke Army Medical Center

People needed

610

Starts

2002-02-01

Expected to finish

2010-01-01

Last updated by the study team

2012-02-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• willing to give written informed consent and be able to adhere to dose and visit schedules.
• 18years of age or older of either gender and any race. Subjects who are over 65 years of age must be in generally good health.
• Serum positive for HCV-RNA by PCR assay Treatment naïve Genotype 1 \& 4 HCV participants
• ALT either elevated or persistently normal
• Liver biopsy within 36 months with a pathology report confirming the histological diagnosis is consistent with CHC
• Compensated liver disease with the following minimum hematologic, biochemical, and serologic criteria at the Entry Visit
• Hemoglobin values of <12 gm/dL for females \& <13 gm/dL for males.
• WBC <3,000/mm3
• Neutrophil count < 1,500/mm3
• Platelets <65,000/mm3
• Direct bilirubin, within 20% of (ULN)
• Indirect bilirubin, WNL (unless non-hepatitis related factors such as Gilbert's disease explain an indirect bilirubin rise
• Albumin, WNL
• Serum creatinine, within 20% of ULN
• Glucose should be less than 115 mg/dL
• Thyroid Stimulating Hormone (TSH), WNL
• HIV negative
• HBsAg negative
• Alpha fetoprotein value < 100 ng/mL obtained within one year prior to entry for patients with Stage 3 or 4 liver disease
• Reconfirmation \& documentation sexually active female subjects of childbearing potential are practicing adequate contraception during the treatment period \& 6 months following the last dose of study medication
• Reconfirmation that sexually active male subjects are practicing acceptable methods of contraception during the treatment period \& for 6 months following the last dose of study medication

You may not qualify if…

• Women who are pregnant or nursing.
• Hepatitis C of non-genotype 1 or 4
• Previous anti-viral therapy
• Suspected hypersensitivity to interferon, PEG-interferon, ribavirin
• Any other cause for the liver disease other than chronic hepatitis C including but not limited to:
• Co-infection with HBV
• Hemochromatosis
• Alpha-1 antitrypsin deficiency
• Wilson's disease
• Autoimmune hepatitis
• Alcoholic liver disease
• Obesity-induced liver disease
• Drug-related liver disease
• Hemophilia or any other condition that would prevent the subject from having a liver biopsy, including anticoagulant therapy
• Hemoglobinopathies
• Evidence of advanced liver disease (ascites, bleeding varices,spontaneous encephalopathy)
• organ transplants other than cornea and hair transplant.
• Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:Preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded
• CNS trauma or active seizure disorders requiring medication
• Significant cardiovascular dysfunction within the past 12 months. Subjects with ECG showing clinically significant abnormalities
• Poorly controlled DM
• Chronic pulmonary disease (COPD)with documented pulmonary hypertension
• Immunologically mediated disease (e.g., inflammatory bowel disease, RA, idiopathic thrombocytopenia purpura, lupus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis)
• Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids
• Active gout

Where it is running

• Brooke Army Medical Center — Fort Sam Houston, Texas, United States

Full record on ClinicalTrials.gov

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