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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brooke Army Medical Center
• Collaborator: T.R.U.E. Research Foundation
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Substance abuse

• not willing to be abstain from the consumption of alcohol.

• clinically significant retinal abnormalities

• Any other condition that in the opinion of the Investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol

• Known HIV Positive