Comparison of Standard Therapy,Peginterferon Alpha-2a + Ribavirin for 48 Weeks VS Peginterferon Alph-2a + Ribavirin + Betaine for 12 Weeks Followed by 36 Weeks Standard Therapy in Untreated Adults With Chronic Hepatitis C Genotype 1

0159-07-FB

The primary purpose of the study is to compare the safety and effectiveness of standard treatment for chronic hepatitis C using peginterferon alpha-2a (Pegasys) and ribavirin (Copegus) to those same medications plus a dietary supplement called betaine when added for the first 12 weeks of treatment. Peginterferon alpha-2a (Pegasys) and ribavirin (Copegus) are approved by the FDA (Food and Drug Administration) for the treatment of chronic hepatitis C. Betaine is a dietary supplement and occurs naturally in the body. It is not a medication regulated by the FDA or an approved drug for chronic hepatitis C.

2008-04-01

2010-03-04

2010-03-04

Withdrawn

Inclusion Criteria: * Subject must be willing to give informed consent and be able to adhere to dose and visit schedules. * History of chronic hepatitis C as documented by either anti-HCV or HCV RNA positivity. * Adult subjects 19-70 years of age, of either gender * Liver biopsy within 3 years prior to the screening 1 visit. * Compensated liver disease with the following maximum hematologic, biochemical and serologic criteria at the Screening visit (WNL=within normal limits) Hemoglobin \> 12 g/dl for females and \>13 g/dl for males, WBC \> 3000/mm3, Platelets \> 80,000/mm3, Direct Bilirubin - WNL. Indirect bilirubin - WNL, Albumin - WNL, Serum Creatinine - WNL. * Fasting glucose should be 70 -140 mg/dl, results between 116-140 require a HbA1c \< 8.5% * TSH - WNL * Subjects with a history of mild depression may be considered for entry in to this study provided that a pretreatment assessment of the subject's affective status supports that the subject is clinically stable. * Subjects with a history of substance abuse must have abstained from using the substance for at least one year prior to the Screening visit. * Antinuclear antibodies (ANA) \< 1:320 * No radiologic evidence of a focal mass suggestive of hepatoma and/or ascites. Exclusion Criteria: * Pregnant or nursing subjects. Subjects who intend to become pregnant during the study period. Subjects with partners who intend to become pregnant during the study period. * History of new hepatitis C exposure within the last 6 months * Prior treatment for chronic hepatitis C. * Current or intended use of G-CSF and/or GM-CSF during the stud period is prohibited. Current use of erythropoietin (EPO) is prohibited. * Suspected hypersensitivity to any interferon product or ribavirin * Participation in any other clinical trial within 30 days of Screening visit * Treatment with any investigational drug within 30 days of Screening visit 1. * Any other cause for liver disease other than CHC. * Coagulopathies including hemophilia * Hemoglobinopathies * G6PD deficiency * Coinfection with HIV and/or HBV * Evidence of active or suspected malignancy or a history of malignancy within the last five years (with the exception of adequately treated basal cell carcinoma of the skin). * Evidence of decompensated liver disease such as history or presence of ascites, bleeding varices or hepatic encephalopathy * Subjects with organ transplants other than cornea or hair transplant * Any Known preexisting medical condition, that could interfere with the subject's participation in and completion of the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-08-15