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

Baqiyatallah Medical Sciences University

Status and phase: Completed; Phase 4

Conditions: Thalassemia; Hepatitis C

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00707850

BRCGL-08-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

1

Experimental group

Description:

Thalassemic Patients with HCV

Treatment:

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