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

NCT ID: NCT00707772

Last Updated: 2009-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-09-30

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.

Conditions

Hepatitis C; Hemophilia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Genotype 2 or 3 in Hemophilic Patients with HCV

Group Type: ACTIVE_COMPARATOR

PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)

Intervention Type: DRUG

PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: 800 milligram per day (PO)

2

Other Genotypes (except 2 or 3) in Hemophilic Patients with HCV

Group Type: ACTIVE_COMPARATOR

PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)

Intervention Type: DRUG

PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: \[=\<75 kg: 1000 mg; \>75 kg: 1200 mg per day (PO)\]

Interventions

PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)

PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: 800 milligram per day (PO)

Intervention Type: DRUG

PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)

PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: \[=\<75 kg: 1000 mg; \>75 kg: 1200 mg per day (PO)\]

Intervention Type: DRUG

Other Intervention Names

Peginterferon Alfa-2a (40KD) Plus COPEGUS; Peginterferon Alfa-2a (40KD) plus COPEGUS

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

OTHER

Sponsor Role: collaborator

Tehran Hepatitis Center

OTHER

Sponsor Role: collaborator

Guilan University of Medical Sciences

OTHER

Sponsor Role: collaborator

Tabriz Research Center for Gastroenterology and Liver Diseases

UNKNOWN

Sponsor Role: collaborator

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: collaborator

Iran University of Medical Sciences

OTHER

Sponsor Role: collaborator

Baqiyatallah Medical Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Principal Investigators

Professor Seyed-Moayed Alavian, Professor

Role: STUDY_CHAIR

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Seyyed Mohammad Miri, M.D.

Role: STUDY_DIRECTOR

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Maryam Keshvari, M.D.

Role: PRINCIPAL_INVESTIGATOR

Iranian blood Transfusion Research Center

Bita Behnava, M.D.

Role: PRINCIPAL_INVESTIGATOR

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Mohammad Hossein Somi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Research Center for Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Tabriz

Fariborz Mansour-Ghanaei, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology and Liver Diseases, Gastrointestinal and Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran

Pegah Karimi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Bashir HajiBeigi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Iranian Blood Transfusion Research Center

Locations

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Tehran, Tehran Province, Iran

Countries

Iran

References

Iafolla M. [Pegasys: FDA approved Pegasys (peginterferon alfa-2a) for the treatment of hepatitis C]. Sidahora. 2002;(4):8-10. No abstract available. Spanish.

Reference Type: BACKGROUND

PMID: 12703472 (View on PubMed)

Other Identifiers

BRCGL-07-03

Identifier Type: -

Identifier Source: secondary_id

BRCGL-07-03

Identifier Type: -

Identifier Source: org_study_id