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Pegasys® Plus Ribavirin in Hemophilic Patients With Hepatitis C Virus Infection

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ClinicalTrials.gov Identifier: NCT00707772
Recruitment Status : Completed
First Posted : July 1, 2008
Last Update Posted : September 17, 2009
Sponsor:
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
Information provided by:
Baqiyatallah Medical Sciences University

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Hemophilia Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Hemophilic Patients With Chronic Hepatitis C Infection
Study Start Date : March 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009


Arm Intervention/treatment
Active Comparator: 1
Genotype 2 or 3 in Hemophilic Patients with HCV
Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: 800 milligram per day (PO)
Other Name: Peginterferon Alfa-2a (40KD) Plus COPEGUS

Active Comparator: 2
Other Genotypes (except 2 or 3) in Hemophilic Patients with HCV
Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: [=<75 kg: 1000 mg; >75 kg: 1200 mg per day (PO)]
Other Name: Peginterferon Alfa-2a (40KD) plus COPEGUS




Primary Outcome Measures :
  1. Early Virologic Response [ Time Frame: After 12 weeks of Treatment ]
  2. End of Treatment Response [ Time Frame: 24 weeks for : Genotype 2 & 3; 48 Weeks for other genotype ]
  3. Sustained Virologic Response [ Time Frame: 24 weeks after Treatment ]
  4. Rapid Virologic Response [ Time Frame: One month after Treatment ]

Secondary Outcome Measures :
  1. Tolerability of drugs for whole therapy period [ Time Frame: During Treatment ]
  2. Biochemical response (ALT) [ Time Frame: End of Treatment AND 24 weeks after Treatment ]
  3. Laboratory Parameters [ Time Frame: During Treatment AND End of treatment ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707772


Locations
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Iran, Islamic Republic of
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran, Iran, Islamic Republic of, 14155-3651
Sponsors and Collaborators
Baqiyatallah Medical Sciences University
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
Investigators
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Study Chair: Professor Seyed-Moayed Alavian, Professor Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Study Director: Seyyed Mohammad Miri, M.D. Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Principal Investigator: Maryam Keshvari, M.D. Iranian blood Transfusion Research Center
Principal Investigator: Bita Behnava, M.D. Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Principal Investigator: Mohammad Hossein Somi, M.D. Research Center for Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Tabriz
Principal Investigator: Fariborz Mansour-Ghanaei, M.D. Gastroenterology and Liver Diseases, Gastrointestinal and Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran
Principal Investigator: Pegah Karimi, M.D. Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Principal Investigator: Bashir HajiBeigi, M.D. Iranian Blood Transfusion Research Center

Additional Information:
Publications:
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Responsible Party: Professor Seyed-Moayed Alavian, Baqiyatallah Research Center for Gastroenterology and Liver Diseases
ClinicalTrials.gov Identifier: NCT00707772     History of Changes
Other Study ID Numbers: BRCGL-07-03
BRCGL-07-03
First Posted: July 1, 2008    Key Record Dates
Last Update Posted: September 17, 2009
Last Verified: September 2009
Keywords provided by Baqiyatallah Medical Sciences University:
Hepatitis C
Hemophilia
Pegasys
Ribavirin
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Hemophilia A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs