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An Observational Study To Assess Liver Fibrosis Stages in Patients With Chronic Hepatitis C Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01671046
First received: August 20, 2012
Last updated: November 3, 2014
Last verified: November 2014

August 20, 2012
November 3, 2014
July 2012
March 2015   (final data collection date for primary outcome measure)
  • Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Correlation of liver elasticity evolution with viral kinetics [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01671046 on ClinicalTrials.gov Archive Site
  • Safety: incidence of adverse events [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Correlation of liver fibrosis stages with sustained virological response (SVR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Correlation of patients characteristics with sustained virological response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Hepatic transient elastography (M-transducer) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Hepatic transient elastography (XL-transducer) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Correlation of hepatic steatosis score with sustained virological response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study To Assess Liver Fibrosis Stages in Patients With Chronic Hepatitis C Infection
Prospective Multicenter Observational Trial to Evaluate Correlation Between Liver Biopsy and Transient Elastography in Liver Fibrosis Assessment and Correlation Between Viral Kinetics and Transient Elastography Evolution During Hepatitis C Treatment in a Population of Chronic HCV Infected Patients

This multi-center, prospective observational study will evaluate the correlation of liver biopsy and transient elastography in liver fibrosis assessment in pati ents with chronic hepatitis C. Data will be collected for 96 weeks.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Biopsy of the liver

Probability Sample

Patients with chronic hepatitis C

Hepatitis C, Chronic
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
123
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic Hepatitis C infection (mono-infection or co-infection with human immunodeficiency virus [HIV])
  • Detectable level of hepatitis C RNA
  • Initiating treatment with pegylated interferon plus ribavirin, or pegylated interferon plus ribavirin, and boceprevir or telaprevir according to local guidelines
  • Last liver biopsy performed no later than 3 months prior to enrolment to study

Exclusion Criteria:

  • Co-infection with hepatitis B virus
  • Previous treatment with pegylated interferon and ribavirin
  • Participation in another clinical study in the last 12 months prior to study start
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01671046
ML27944
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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