Hepatitis C
Conditions
Brief summary
Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a (Pegaferon®) in the patients with chronic hepatitis C.
Detailed description
We enroll 50 patients in to the study. The patients receive Pegaferon® 180 micgr per week plus ribavirin 10-15mg/kg per day. The patients are visited every 4 weeks with biochemistry lab tests. They are checked with quantitative HCV PCR on the third month after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.
Interventions
Pegaferon: Ampule, 180 microgram per week Ribaverin: Tablet, 10-15 mg/kg per day
Sponsors
Kermanshah University of Medical Sciences
Tehran Hepatitis Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HCV RNA: Positive * Biopsy approved in genotype 1 * Age older than 18 yrs
Exclusion criteria
* ongoing pregnancy or breast feeding * Hx of hemochromatosis * Hx of metabolic liver dis. * Hx of HCC * Hx of autoimmune hepatitis * Hx of alcoholic liver dis. * Hx of bleeding from esophageal varices * ongoing systemic anti-viral or anti-neoplasmic treatment * Hx of treatment with an anti-depressant medication at therapeutic doses for at least 3 months at any pervious time * Hx of treatment with an tranquilizer at therapeutic doses for psychosis for at least 3 months at any pervious time * Hx of hospitalization for psychiatric dis. * Hx of suicidal attempt * Hx of IBD * Hx of SLE * Hx of scleroderma * Hx of rheumatoid arthritis * Hx of ITP * Hx of autoimmune hemolytic anemia * Hx of severe psoriasis * Hx of chronic pulmonary dis. associated with functional limitation * Hx of MI or unstable angina * Hx of arrhythmia requiring ongoing treatment * Hx of functional class III or IV * Hx of severe seizure dis. or current anti-convulsant use * Hx of organ transplantation with existing functional graft * Hx of severe retinopathy * Hx of Thalassemia * Hx of spherocytosis * Hx of cerebrovascular dis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| End of treatment response rate (HCV RNA:Neg) | End of treatment course |
Secondary
| Measure | Time frame |
|---|---|
| Sustain response rate (HCV RNA:Neg) 6 month after end of treatment | 6 month after end of treatment |
Countries
Iran
Outcome results
None listed