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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00707850

Enrollment

300

Registered

2008-07-01

Start date

2007-05-31

Completion date

2009-09-30

Last updated

2010-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Thalassemia

Keywords

Hepatitis C, Thalassemia, Pegasys, Ribavirin

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.

Interventions

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

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026