Non-randomized Prospective Study on the Effect of Antiviral Therapy With Peginterferon Alfa-2a and Ribavirin on Bone Mineral Density and Metabolism in Patients With Chronic Viral Hepatitis C Genotype 1
Sponsor study identifier
interventional
26
1 country
1
Study Start
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2007
Actual (reported)Study Completion
March 2008
Actual (reported)One single study has suggested that bone mineral density (BMD) is reduced in patients with non-cirrhotic chronic viral hepatitis C. Antiviral combination therapy with standard interferon and ribavirin may further decrease BMD. The aim of this study is to systematically investigate the effect of chronic hepatitis C genotype 1 infection alone and current standard therapy with peginterferon alfa-2a/ribavirin on BMD and bone metabolism.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
January 2007
Actual (reported)March 2008
Actual (reported)July 24, 2009
Actual (reported)July 29, 2009
Actual (reported)Change of the bone mineral density of the lumbar spine and right hip measured by DEXA in patients with chronic hepatitis C with or without antiviral combination treatment with peginterferon and ribavirin
96 weeks
Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy.
96 weeks
Chronic hepatitis C patients on standard antiviral therapy with peginterferon alfa-2a and ribavirin
Chronic hepatitis C patients without standard antiviral therapy
standard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d
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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 recordUniversity Hospital Ulm
Ulm, 89081, Germany
Michael Fuchs, MD
University of Ulm
26 participants (actual enrollment reported by the registry).
First Submitted
July 24, 2009
First Posted
July 29, 2009
Study Start
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3
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Primary Completion
January 2007
Actual (reported)Study Completion
March 2008
Actual (reported)Last Updated
June 7, 2011
Record last verified: 2011-05
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Source: ClinicalTrials.gov.
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