Pegaferon and Ribavirin for Hepatitis C
Phase 3
Completed
- Conditions
- Hepatitis C
- Interventions
- Registration Number
- NCT01137383
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be treated using standard guidelines for hepatitis C. Response to treatment and side effects will be recorded.
- Detailed Description
The product is locally produced and needs to be evaluated in terms of efficacy and safety.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
Inclusion Criteria
- Chronic hepatitis C
- Age between 15 and 65
Exclusion Criteria
- previous treatment for chronic hepatitis C
- co-infection with human immunodeficiency virus or hepatitis B virus
- major thalassemia or hemophilia
- active drug user
- being treated for major depression or psychosis
- decompensated cirrhosis
- serum creatinine > 1.5 mg/dL
- solid organ transplant
- untreated thyroid disease
- uncontrolled diabetes mellitus
- uncontrolled autoimmune disease
- advanced cardiac or pulmonary disease.
- planning to become pregnant in the next 1.5 years
- patients with inadequate contraception
- not consenting to the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment group Pegaferon (pegylated interferon alpha 2a) + ribavirin -
- Primary Outcome Measures
Name Time Method Sustained viral response 6 months after end of treatment Negative hepatitis C viral RNA with a highly sensitive assay 6 months after end of treatment
- Secondary Outcome Measures
Name Time Method Adverse drug events 18 months from start of treatment Any adverse event reported by patient or seen in laboratory data
Trial Locations
- Locations (2)
Emam Hospital
🇮🇷Tehran, Iran, Islamic Republic of
Shariati Hospital
🇮🇷Tehran, Iran, Islamic Republic of