NCT00502788|CompletedPhase 2DMC
Evaluating the Safety of Two Medications to Treat Hepatitis C in People With Thalassemia (The HepC Study)
HepC
Thalassemia Clinical Research Network - Hepatitis C Clinical Trial
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Sponsor study identifier
Secondary identifiers
interventional
21
3 countries
5
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2006
Actual (reported)Study Completion
August 2006
Actual (reported)Hepatitis C is one of the most common causes of long-term liver disease in the United States. Ribavirin and peginterferon alfa-2a are two medications that are used to treat hepatitis C infection. The purpose of this study is to evaluate the safety of these two medications in adults with hepatitis C and thalassemia, a type of blood disorder.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
June 2006
Actual (reported)August 2006
Actual (reported)July 16, 2007
Actual (reported)July 18, 2007
Actual (reported)Safety of peginterferon alfa-2a and ribavirin in individuals with thalassemia (measured by changes in liver iron stores and development of iron overload-related complications)
Measured at Week 72
Mean change in hepatic iron concentration from baseline biopsy to follow-up biopsy; relationship of change to baseline level
Measured at Week 48
Transfusion frequency and volume required to maintain trough Hb 9.0-10.5 g/dL during treatment, as compared to that required in the 6 months prior to hepatitis C treatment
Measured at Week 72
Cumulate change in deferoxamine dose; evidence for deferoxamine toxicity during hepatitis C treatment
Measured at Week 72
Response rate (undetectable hepatitis C virus RNA)
Measured at Week 24 or 48
Sustained virologic response rate (undetectable hepatitis C virus RNA 24 weeks after the end of treatment) and its association with baseline hepatic iron concentration
Measured at Week 72
Patients will be treated with alfa-2a and ribavirin as follows: Peginterferon alfa-2a will be started as a dose of 180 ug subcutaneously once weekly.
Ribavirin will be started at a dose of 800mg daily for those weighing less than or equal to 50 kg, 1000 mg daily for those with body weight 51 to 75 kg and 1200 mg daily for those with body weight \> 75 kg. Ribavirin will be given orally in two divided doses. The lower dose has been included because potentially-eligible patients in the TCRN registry have a mean weight of 57 kg.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Peginterferon Alfa-2a and Ribavirin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordChildren's Hospital and Research Center at Oakland
Oakland, California, 94609, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
Children's Hospital Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Toronto General Hospital, Universty Health Network
Toronto, Ontario, M5G 2C4, Canada
University College London
London, WC1E 6HX, United Kingdom
Maureen Jonas, MD
Boston Children's Hospital
21 participants (actual enrollment reported by the registry).
First Submitted
July 16, 2007
First Posted
July 18, 2007
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Antiviral & Antifibrotic Liver Therapy in HCV + Drinkers and Non-Drinkers
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 2006
Actual (reported)Study Completion
August 2006
Actual (reported)Last Updated
March 4, 2014
Record last verified: 2014-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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