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

NCT ID: NCT00527540

Last Updated: 2009-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-12-31

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Pegylated Interferon alpha 2a + Ribavirin

Pegaferon: Ampule, 180 microgram per week Ribaverin: Tablet, 10-15 mg/kg per day

Intervention Type: DRUG

Other Intervention Names

Pegaferon

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kermanshah University of Medical Sciences

OTHER

Sponsor Role: collaborator

Tehran Hepatitis Center

OTHER

Sponsor Role: lead

Responsible Party

Tehran Hepatitis Center

Principal Investigators

Seyed M Alavian, Prof.

Role: STUDY_CHAIR

Tehran Hepatitis Center

Behzad Hajarizadeh, MD

Role: PRINCIPAL_INVESTIGATOR

Tehran Hepatitis Center

Locations

Tehran Hepatitis Center

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

THC-10

Identifier Type: -

Identifier Source: org_study_id