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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00707850
Recruitment Status : Completed
First Posted : July 1, 2008
Last Update Posted : August 31, 2010
Sponsor:
Collaborators:
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran Hepatitis Center
Guilan University of Medical Sciences
Tabriz Research Center for Gastroenterology and Liver Diseases
Information provided by:
Baqiyatallah Medical Sciences University

Tracking Information
First Submitted Date  ICMJE June 26, 2008
First Posted Date  ICMJE July 1, 2008
Last Update Posted Date August 31, 2010
Study Start Date  ICMJE May 2007
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2008)
  • Early Virologic Response [ Time Frame: After 12 weeks of Treatment ]
  • End of Treatment Response [ Time Frame: 48 Weeks ]
  • Sustained Virologic Response [ Time Frame: 24 weeks after Treatment ]
  • Rapid Virologic Response [ Time Frame: One month after Treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2008)
  • Tolerability of drugs for whole therapy period [ Time Frame: During Treatment ]
  • Biochemical response (ALT) [ Time Frame: End of Treatment AND 24 weeks after Treatment ]
  • Laboratory Parameters [ Time Frame: During Treatment AND End of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pegasys® Plus Ribavirin in Thalassemic Patients With Hepatitis C Virus Infection
Official Title  ICMJE A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Thalassemic Patients With Chronic Hepatitis C Infection
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis C
  • Thalassemia
Intervention  ICMJE Drug: PEGASYS® (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)]
Other Name: Peginterferon Alfa-2a (40KD) plus COPEGUS
Study Arms  ICMJE Experimental: 1
Thalassemic Patients with HCV
Intervention: Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 30, 2008)		 300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00707850
Other Study ID Numbers  ICMJE BRCGL-08-06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Professor Seyed-Moayed Alavian, Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Baqiyatallah Medical Sciences University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Baqiyatallah Research Center for Gastroenterology and Liver Diseases
  • Tehran Hepatitis Center
  • Guilan University of Medical Sciences
  • Tabriz Research Center for Gastroenterology and Liver Diseases
Investigators  ICMJE
Study Chair: Seyed-Moayed Alavian, Professor Baqiyatallah Research Center for Gastroenterology and Liver Disea
Study Director: Seyyed Mohammad Miri, M.D. Baqiyatallah Research Center for Gastroenterology and Liver Disea
Principal Investigator: Pegah Karimi, M.D. Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Principal Investigator: Maryam Keshvari, M.D. Iranian blood Transfusion Research Center
Principal Investigator: Bita Behnava, M.D. Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Principal Investigator: Mohammad Hossein Somi, M.D. Research Center for Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Tabriz
Principal Investigator: Fariborz Mansour-Ghanaei, M.D. Gastroenterology and Liver Diseases, Gastrointestinal and Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran
PRS Account Baqiyatallah Medical Sciences University
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP