Clinical trial NCT00707772: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Hemophilia
Keywords: Hepatitis C
Hemophilia
Pegasys
Ribavirin
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
Collaborators: name: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
name: Tehran Hepatitis Center
name: Guilan University of Medical Sciences
name: Tabriz Research Center for Gastroenterology and Liver Diseases
name: Shahid Beheshti University of Medical Sciences
name: Iran University of Medical Sciences
First posted: 2008-07-01
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Early Virologic Response
timeFrame: After 12 weeks of Treatment
measure: End of Treatment Response
timeFrame: 24 weeks for : Genotype 2 & 3; 48 Weeks for other genotype
measure: Sustained Virologic Response
timeFrame: 24 weeks after Treatment
measure: Rapid Virologic Response
timeFrame: One month after Treatment
Secondary outcomes:
measure: Tolerability of drugs for whole therapy period
timeFrame: During Treatment
measure: Biochemical response (ALT)
timeFrame: End of Treatment AND 24 weeks after Treatment
measure: Laboratory Parameters
timeFrame: During Treatment AND End of treatment
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Study officials:
affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
name: Professor Seyed-Moayed Alavian, Professor
role: STUDY_CHAIR
affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
name: Seyyed Mohammad Miri, M.D.
role: STUDY_DIRECTOR
affiliation: Iranian blood Transfusion Research Center
name: Maryam Keshvari, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
name: Bita Behnava, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Center for Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Tabriz
name: Mohammad Hossein Somi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gastroenterology and Liver Diseases, Gastrointestinal and Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran
name: Fariborz Mansour-Ghanaei, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
name: Pegah Karimi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Iranian Blood Transfusion Research Center
name: Bashir HajiBeigi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.