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Completed

NCT Number: NCT00707850

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Drug

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

Other names: Peginterferon Alfa-2a (40KD) plus COPEGUS

Primary outcomes

  1. Early Virologic Response

    Time frame: After 12 weeks of Treatment

  2. End of Treatment Response

    Time frame: 48 Weeks

  3. Sustained Virologic Response

    Time frame: 24 weeks after Treatment

  4. Rapid Virologic Response

    Time frame: One month after Treatment

Secondary outcomes

  1. Tolerability of drugs for whole therapy period

    Time frame: During Treatment

  2. Biochemical response (ALT)

    Time frame: End of Treatment AND 24 weeks after Treatment

  3. Laboratory Parameters

    Time frame: During Treatment AND End of treatment

Sponsors and collaborators

Lead sponsor

Baqiyatallah Medical Sciences University

Other

Collaborators

  • Baqiyatallah Research Center for Gastroenterology and Liver Diseases
  • Guilan University of Medical Sciences
  • Tabriz Research Center for Gastroenterology and Liver Diseases
  • Tehran Hepatitis Center

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 1, 2008
Registry last updated
Aug 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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