Asian Americans, Chronic Hepatitis C, Novel Genotypes, Treatment
Conditions
Keywords
Hepatitis C, Genotype 6, Novel genoytpe, HCV, Treatment
Brief summary
The purpose of this research study is to test the safety, tolerability, and effectiveness of the drugs Pegasys and Copegus when used for hepatitis C genotypes 6, 7, 8, and 9. Patients are randomly assigned (by chance) to either Treatment Group A (Pegasys and Copegus for 24 weeks) or Treatment Group B (Pegasys and Copegus for 48 weeks).
Interventions
180 ug of peg-IFN per week and 1000-1200 mg of ribavirin per day (weight-dependent). Treatment duration is determined by treatment arm.
Sponsors
Hoffmann-La Roche
Pacific Health Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The subject must meet the following criteria for entry. * Subject must be willing to give written informed consent and be able to adhere to dose and visit schedules. * Adult subjects 18-70 years of age of both gender and any race as long as they have HCV genotype 6, 7, 8, and 9. * Serum positive for HCV-RNA by PCR (qPCR) assay, or bDNA * Liver biopsy within 24 months prior to entry to this protocol with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis C with stage II or more fibrosis. Biopsy must be scored or be re-read to score fibrosis stage and grade and severity of steatosis. * Compensated liver disease with the following minimum hematologic, biochemical, and serologic criteria at the Entry Visit (WNL = within normal limits). * Hemoglobin (Hb) greater than or equal to12 gm/dL for women and 13 gm/dL for men. * White blood cell count (WBC) greater than or equal to 2,000/mm3 * Platelets (PLT) greater than or equal to 90,000/mm3 * Direct bilirubin (DB) less than or equal to 1.0 * Indirect bilirubin (IB) = WNL or greater than or equal to 3.0 mg/dL if this is due to non-hepatitis related factors such as Gilbert's disease. * Creatinine (Cr) clearance greater than or equal to50 mL/minute or serum Cr greater than or equal to 1.5x UNL at screening. * Fasting glucose (FBS) less than or equal to160 mg/dL and Hb A1c greater than or equal to 8.5% for diabetic subjects (whether on medication or diet controlled). * Thyroid Stimulating Hormone (TSH) = WNL (Subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/
Exclusion criteria
are met.) * Serum anti-HIV = negative * Serum HBsAg = negative * Abdominal ultrasound negative for liver masses within 3 months prior to entry. Patients without cirrhosis or transition to cirrhosis may have there imaging studies done within 12 months of study entry. * Alpha-fetoprotein (AFP) less than or equal to 20 ng/mL obtained within 3 months prior to entry. Patients with 20 ng/mL less than or equal to AFP less than or equal to 100ng/mL may be enrolled after a normal biphasic abdominal CT within the previous 3 months if patients have Stage III/IV fibrosis and after a normal ultrasound if patients have Stage I/II fibrosis. If AFP is more than 100 but less than 200 ng/dL, all patients need to have a negative biphasic CT within 3 months. * Female subjects must not be breast-feeding. * A pregnancy test must be obtained within 24 hours to the first dose of study drugs and must be negative. * Additionally, all fertile males and females must use two reliable forms of effective contraception (combined) during treatment with study drugs and 6 months after treatment completion. * Acceptable forms of contraception may include intrauterine device, oral contraceptives, progesterone implanted rods \[Norplant\], medroxyprogesterone acetate \[Depo-Provera\], surgical sterilization, barrier method \[diaphragm + spermicide or condom + spermicide\]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virologic response | 24 weeks post-treatment |
Countries
United States
Outcome results
None listed