Pegaferon and Ribavirin for Hepatitis C
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pegaferon (pegylated interferon alpha 2a) + ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C
Eligibility Criteria
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
Sites / Locations
- Emam Hospital
- Shariati Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
Outcomes
Primary Outcome Measures
Sustained viral response
Negative hepatitis C viral RNA with a highly sensitive assay 6 months after end of treatment
Secondary Outcome Measures
Adverse drug events
Any adverse event reported by patient or seen in laboratory data
Full Information
NCT ID
NCT01137383
First Posted
June 3, 2010
Last Updated
June 28, 2010
Sponsor
Tehran University of Medical Sciences
Collaborators
Pars No Tarkib Co
1. Study Identification
Unique Protocol Identification Number
NCT01137383
Brief Title
Pegaferon and Ribavirin for Hepatitis C
Official Title
Safety and Efficacy of Locally Manufactured Pegylated Interferon in Hepatitis C Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tehran University of Medical Sciences
Collaborators
Pars No Tarkib Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pegaferon (pegylated interferon alpha 2a) + ribavirin
Other Intervention Name(s)
Pegaferon
Intervention Description
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
Primary Outcome Measure Information:
Title
Sustained viral response
Description
Negative hepatitis C viral RNA with a highly sensitive assay 6 months after end of treatment
Time Frame
6 months after end of treatment
Secondary Outcome Measure Information:
Title
Adverse drug events
Description
Any adverse event reported by patient or seen in laboratory data
Time Frame
18 months from start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Malekzadeh, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Emam Hospital
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Shariati Hospital
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
20597564
Citation
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.
Results Reference
derived
Learn more about this trial
Pegaferon and Ribavirin for Hepatitis C
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