Pegasys® Plus Ribavirin in Hemophilic Patients With Hepatitis C Virus Infection
Primary Purpose
Hepatitis C, Hemophilia
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Hemophilia, Pegasys, Ribavirin
Eligibility Criteria
Inclusion Criteria:
- HCV RNA positive
- Age older than 12 years
Exclusion Criteria:
- Ongoing pregnancy or breast feeding
- Hx of HCC
- Hx of alcoholic liver disease
- Hx of bleeding from esophageal varices
- Hx of hemochromatosis
- Hx of autoimmune hepatitis
- Hx of Suicidal attempt
- Hx of cerebrovascular dis
- Hx of severe retinopathy
- Hx of severe psoriasis
- Hx of scleroderma
- Hx of metabolic liver disease
- Hx of SLE
Sites / Locations
- Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Genotype 2 or 3 in Hemophilic Patients with HCV
Other Genotypes (except 2 or 3) in Hemophilic Patients with HCV
Outcomes
Primary Outcome Measures
Early Virologic Response
End of Treatment Response
Sustained Virologic Response
Rapid Virologic Response
Secondary Outcome Measures
Tolerability of drugs for whole therapy period
Biochemical response (ALT)
Laboratory Parameters
Full Information
NCT ID
NCT00707772
First Posted
June 26, 2008
Last Updated
September 16, 2009
Sponsor
Baqiyatallah Medical Sciences University
Collaborators
Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Tehran Hepatitis Center, Guilan University of Medical Sciences, Tabriz Research Center for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Iran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00707772
Brief Title
Pegasys® Plus Ribavirin in Hemophilic Patients With Hepatitis C Virus Infection
Official Title
A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Hemophilic Patients With Chronic Hepatitis C Infection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Baqiyatallah Medical Sciences University
Collaborators
Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Tehran Hepatitis Center, Guilan University of Medical Sciences, Tabriz Research Center for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Iran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hemophilic patients are a known high risk groups for acquiring the hepatitis C. The surveillance data from Ministry Of Health in IR.Iran had shown that 60% of them are infected with HCV infection. We are trying the PEGASYS plus Ribavirin in Hemophilic patients with HCV.
Detailed Description
The investigators enroll 400 patients into the study. The patients receive PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 800 microgram for Genotype 2 and 3 and 1000 milligram for weight less than 75 kg and 1200 milligram for more than 75 kg. The duration of protocol is depends on genotypes of virus. In genotype 1 and 4, for 48 week and in genotypes 2 and 3 , for 24 weeks. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA on the third months 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. We have omitted the liver biopsy in the patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Hemophilia
Keywords
Hepatitis C, Hemophilia, Pegasys, Ribavirin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Genotype 2 or 3 in Hemophilic Patients with HCV
Arm Title
2
Arm Type
Active Comparator
Arm Description
Other Genotypes (except 2 or 3) in Hemophilic Patients with HCV
Intervention Type
Drug
Intervention Name(s)
PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
Other Intervention Name(s)
Peginterferon Alfa-2a (40KD) Plus COPEGUS
Intervention Description
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: 800 milligram per day (PO)
Intervention Type
Drug
Intervention Name(s)
PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
Other Intervention Name(s)
Peginterferon Alfa-2a (40KD) plus COPEGUS
Intervention Description
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: [=<75 kg: 1000 mg; >75 kg: 1200 mg per day (PO)]
Primary Outcome Measure Information:
Title
Early Virologic Response
Time Frame
After 12 weeks of Treatment
Title
End of Treatment Response
Time Frame
24 weeks for : Genotype 2 & 3; 48 Weeks for other genotype
Title
Sustained Virologic Response
Time Frame
24 weeks after Treatment
Title
Rapid Virologic Response
Time Frame
One month after Treatment
Secondary Outcome Measure Information:
Title
Tolerability of drugs for whole therapy period
Time Frame
During Treatment
Title
Biochemical response (ALT)
Time Frame
End of Treatment AND 24 weeks after Treatment
Title
Laboratory Parameters
Time Frame
During Treatment AND End of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HCV RNA positive
Age older than 12 years
Exclusion Criteria:
Ongoing pregnancy or breast feeding
Hx of HCC
Hx of alcoholic liver disease
Hx of bleeding from esophageal varices
Hx of hemochromatosis
Hx of autoimmune hepatitis
Hx of Suicidal attempt
Hx of cerebrovascular dis
Hx of severe retinopathy
Hx of severe psoriasis
Hx of scleroderma
Hx of metabolic liver disease
Hx of SLE
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Seyed-Moayed Alavian, Professor
Organizational Affiliation
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Seyyed Mohammad Miri, M.D.
Organizational Affiliation
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maryam Keshvari, M.D.
Organizational Affiliation
Iranian blood Transfusion Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bita Behnava, M.D.
Organizational Affiliation
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Hossein Somi, M.D.
Organizational Affiliation
Research Center for Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Tabriz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fariborz Mansour-Ghanaei, M.D.
Organizational Affiliation
Gastroenterology and Liver Diseases, Gastrointestinal and Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pegah Karimi, M.D.
Organizational Affiliation
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bashir HajiBeigi, M.D.
Organizational Affiliation
Iranian Blood Transfusion Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
City
Tehran
ZIP/Postal Code
14155-3651
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
12703472
Citation
Iafolla M. [Pegasys: FDA approved Pegasys (peginterferon alfa-2a) for the treatment of hepatitis C]. Sidahora. 2002;(4):8-10. No abstract available. Spanish.
Results Reference
background
Learn more about this trial
Pegasys® Plus Ribavirin in Hemophilic Patients With Hepatitis C Virus Infection
We'll reach out to this number within 24 hrs