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

Tehran Hepatitis Center

Status and phase

Completed

Phase 3

Conditions

Hepatitis C

Treatments

Drug: Pegylated Interferon alpha 2a + Ribavirin

Study type

Interventional

Funder types

Other

Identifiers

NCT00527540

THC-10

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.