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

Hepatitis C Clinical Trial

Official title:

A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Hemophilic Patients With Chronic Hepatitis C Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707772
• Other study ID #: BRCGL-07-03
• Secondary ID: BRCGL-07-03
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2008
• Last updated: September 16, 2009
• Start date: March 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemophilia
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: 800 milligram per day (PO)
• 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)]

Locations

Country	Name	City	State
Iran, Islamic Republic of	Baqiyatallah Research Center for Gastroenterology and Liver Diseases	Tehran

Sponsors (7)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University	Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Guilan Research Center for Gastroenterology and Liver Diseases, hahid Beheshti University of Medical Sciences, Research Center for Gastroenterology and Liver Disease, Iran University of Medical Sciences, Firoozgar Hospital, Tabriz Research Center for Gastroenterology and Liver Diseases, Tehran Hepatitis Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

Iafolla M. [Pegasys: FDA approved Pegasys (peginterferon alfa-2a) for the treatment of hepatitis C]. Sidahora. 2002;(4):8-10. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Virologic Response		After 12 weeks of Treatment	No
Primary	End of Treatment Response		24 weeks for : Genotype 2 & 3; 48 Weeks for other genotype	No
Primary	Sustained Virologic Response		24 weeks after Treatment	No
Primary	Rapid Virologic Response		One month after Treatment	No
Secondary	Tolerability of drugs for whole therapy period		During Treatment	Yes
Secondary	Biochemical response (ALT)		End of Treatment AND 24 weeks after Treatment	No
Secondary	Laboratory Parameters		During Treatment AND End of treatment	No