Pegaferon and Ribavirin for Hepatitis C
Safety and Efficacy of Locally Manufactured Pegylated Interferon in Hepatitis C Patients
1 other identifier
interventional
108
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 3, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedJune 30, 2010
June 1, 2010
2 years
June 3, 2010
June 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained viral response
Negative hepatitis C viral RNA with a highly sensitive assay 6 months after end of treatment
6 months after end of treatment
Secondary Outcomes (1)
Adverse drug events
18 months from start of treatment
Study Arms (1)
Treatment group
EXPERIMENTALInterventions
pegylated interferon 180 micrograms subcutaneously weekly - ribavirin (oral, in two divided daily doses) 800 mg for genotype 2 and 3, 1000 or 1200mg (weight less than or greater than 75kg) for genotypes 1 and 4 - Duration: 24 weeks for genotype 2 and 3, 48 weeks for genotypes 1 and 4
Eligibility Criteria
You may qualify if:
- Chronic hepatitis C
- Age between 15 and 65
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tehran University of Medical Scienceslead
- Pars No Tarkib Cocollaborator
Study Sites (2)
Emam Hospital
Tehran, Iran
Shariati Hospital
Tehran, Iran
Related Publications (1)
Jabbari H, Bayatian A, Sharifi AH, Zaer-Rezaee H, Fakharzadeh E, Asadi R, Zamini H, Shahzamani K, Merat S, Nassiri-Toosi M. Safety and efficacy of locally manufactured pegylated interferon in hepatitis C patients. Arch Iran Med. 2010 Jul;13(4):306-12.
PMID: 20597564DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Reza Malekzadeh, MD
Tehran University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 3, 2010
First Posted
June 4, 2010
Study Start
December 1, 2007
Primary Completion
December 1, 2009
Study Completion
February 1, 2010
Last Updated
June 30, 2010
Record last verified: 2010-06