Clinical trial NCT00707850: Pegasys® Plus Ribavirin in Thalassemic Patients With Hepatitis C Virus Infection
Official title: A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Thalassemic Patients With Chronic Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Thalassemia
Keywords: Hepatitis C
Thalassemia
Pegasys
Ribavirin
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
Collaborators: name: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
name: Tehran Hepatitis Center
name: Guilan University of Medical Sciences
name: Tabriz Research Center for Gastroenterology and Liver Diseases
First posted: 2008-07-01
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Early Virologic Response
timeFrame: After 12 weeks of Treatment
measure: End of Treatment Response
timeFrame: 48 Weeks
measure: Sustained Virologic Response
timeFrame: 24 weeks after Treatment
measure: Rapid Virologic Response
timeFrame: One month after Treatment
Secondary outcomes:
measure: Tolerability of drugs for whole therapy period
timeFrame: During Treatment
measure: Biochemical response (ALT)
timeFrame: End of Treatment AND 24 weeks after Treatment
measure: Laboratory Parameters
timeFrame: During Treatment AND End of treatment
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Study officials:
affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Disea
name: Seyed-Moayed Alavian, Professor
role: STUDY_CHAIR
affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Disea
name: Seyyed Mohammad Miri, M.D.
role: STUDY_DIRECTOR
affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
name: Pegah Karimi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Iranian blood Transfusion Research Center
name: Maryam Keshvari, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
name: Bita Behnava, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Center for Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Tabriz
name: Mohammad Hossein Somi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gastroenterology and Liver Diseases, Gastrointestinal and Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran
name: Fariborz Mansour-Ghanaei, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harmatz P, Jonas MM, Kwiatkowski JL, Wright EC, Fischer R, Vichinsky E, Giardina PJ, Neufeld EJ, Porter J, Olivieri N; Thalassemia Clinical Research Network. Safety and efficacy of pegylated interferon alpha-2a and ribavirin for the treatment of hepatitis C in patients with thalassemia. Haematologica. 2008 Aug;93(8):1247-51. doi: 10.3324/haematol.12352. Epub 2008 Jun 12.