Pilot Comparison of Standard Antiviral Therapy With and Without 12 Weeks of Betaine in Genotype 1 Naive Patients

• Status: Withdrawn
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Treatments: Betaine; Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

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.