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

Phase 4

Completed

• Conditions: Hepatitis C; Thalassemia
• Interventions: Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)

• Registration Number: NCT00707850
• Lead Sponsor: Baqiyatallah Medical Sciences University

Brief Summary

Antiviral treatment of HCV in thalassemia has raised concerns of ribavirin-induced hemolysis and increased iron loading. Blood Transfusion in Thalassemic patients are a known high risk for acquiring hepatitis C. The investigators are trying the PEGASYS (Peginterferon alpha-2a(40 KD)) plus Ribavirin in Thalassemic patients with HCV.

Detailed Description

Patients with Thalassemia receive chronic blood transfusions and have an increased prevalence of chronic Hepatitis C virus (HCV) infection, particularly if transfused before HCV serological testing became available. The investigators enrolled 300 patients into the study. The patients received PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 1000 milligram for weight less than or equal 75 kg and 1200 milligram for more than 75 kg for 48 weeks. Follow up period is 6 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) 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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-30
• Study First Posted: 2008-07-01
• Status Verified: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Last Update Submitted: 2010-08-30
• Last Update Posted: 2010-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• HCV RNA positive
• Age older than 12 years

Exclusion Criteria

• Ongoing pregnancy or breast feeding
• History (Hx) of Hepatocellular Carcinoma (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 Systemic Lupus Erythematosus (SLE)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)	Thalassemic Patients with HCV

Primary Outcome Measures

Name	Time	Method
Early Virologic Response	After 12 weeks of Treatment
End of Treatment Response	48 Weeks
Sustained Virologic Response	24 weeks after Treatment
Rapid Virologic Response	One month after Treatment

Secondary Outcome Measures

Name	Time	Method
Tolerability of drugs for whole therapy period	During Treatment
Biochemical response (ALT)	End of Treatment AND 24 weeks after Treatment
Laboratory Parameters	During Treatment AND End of treatment

Trial Locations

Locations (1)

Baqiyatallah Research Center for Gastroenterology and Liver Diseases; 🇮🇷 Tehran, Iran, Islamic Republic of