An Observational Study To Assess Liver Fibrosis Stages in Patients With Chronic Hepatitis C 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. Identifier: NCT01671046
Recruitment Status : Completed
First Posted : August 23, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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

Condition or disease
Hepatitis C, Chronic

Study Type : Observational
Actual Enrollment : 123 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : July 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start [ Time Frame: 24 months ]
  2. Correlation of liver elasticity evolution with viral kinetics [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Safety: incidence of adverse events [ Time Frame: 24 months ]
  2. Correlation of liver fibrosis stages with sustained virological response (SVR) [ Time Frame: 24 months ]
  3. Correlation of patients characteristics with sustained virological response [ Time Frame: 24 months ]
  4. Hepatic transient elastography (M-transducer) [ Time Frame: 24 months ]
  5. Hepatic transient elastography (XL-transducer) [ Time Frame: 24 months ]
  6. Correlation of hepatic steatosis score with sustained virological response [ Time Frame: 24 months ]
  7. Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy [ Time Frame: 24 months ]
  8. Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients [ Time Frame: 24 months ]

Biospecimen Retention:   Samples With DNA
Biopsy of the liver

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic hepatitis C

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01671046

Rio de Janeiro, RJ, Brazil, 20270-004
Rio de Janeiro, RJ, Brazil, 21941-590
Botucatu, SP, Brazil, 18600-400
Campinas, SP, Brazil, 13026-210
Campinas, SP, Brazil, 13060-803
Santo Andre, SP, Brazil, 09060-650
Sao Paulo, SP, Brazil, 04040-002
Sao Paulo, SP, Brazil, 04040-003
Sao Paulo, SP, Brazil, 05403-000
Sorocaba, SP, Brazil, 18047-600
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01671046     History of Changes
Other Study ID Numbers: ML27944
First Posted: August 23, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic