- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01137383
Pegaferon and Ribavirin for Hepatitis C
June 28, 2010 updated by: Tehran University of Medical Sciences
Safety and Efficacy of Locally Manufactured Pegylated Interferon in Hepatitis C Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The product is locally produced and needs to be evaluated in terms of efficacy and safety.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Tehran, Iran, Islamic Republic of
- Emam Hospital
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Tehran, Iran, Islamic Republic of
- Shariati Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained viral response
Time Frame: 6 months after end of treatment
|
Negative hepatitis C viral RNA with a highly sensitive assay 6 months after end of treatment
|
6 months after end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse drug events
Time Frame: 18 months from start of treatment
|
Any adverse event reported by patient or seen in laboratory data
|
18 months from start of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
June 3, 2010
First Submitted That Met QC Criteria
June 3, 2010
First Posted (Estimate)
June 4, 2010
Study Record Updates
Last Update Posted (Estimate)
June 30, 2010
Last Update Submitted That Met QC Criteria
June 28, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Ribavirin
- Peginterferon alfa-2a
- Interferon alpha-2
Other Study ID Numbers
- DDRC.86.90
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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