Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tehran Hepatitis Center
• Collaborator: Kermanshah University of Medical Sciences
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

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.