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

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01671046
First received: August 20, 2012
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Hepatitis C, Chronic

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • Safety: incidence of adverse events [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biopsy of the liver


Estimated Enrollment: 294
Study Start Date: July 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with chronic hepatitis C

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671046

Contacts
Contact: Reference Study ID Number: ML27944 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Brazil
Recruiting
Rio de Janeiro, RJ, Brazil, 20270-004
Not yet recruiting
Rio de Janeiro, RJ, Brazil, 20020-022
Recruiting
Botucatu, SP, Brazil, 18600-400
Recruiting
Campinas, SP, Brazil, 13026210
Recruiting
Campinas, SP, Brazil, 13060-803
Recruiting
Santo Andre, SP, Brazil, 09060-650
Not yet recruiting
Santos, SP, Brazil, 11015470
Recruiting
Sao Paulo, SP, Brazil, 04040-003
Not yet recruiting
Sao Paulo, SP, Brazil, 05403-000
Recruiting
Sao Paulo, SP, Brazil, 04040-002
Recruiting
Sorocaba, SP, Brazil, 18047-600
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01671046     History of Changes
Other Study ID Numbers: ML27944
Study First Received: August 20, 2012
Last Updated: May 23, 2013
Health Authority: Brazil: ANVISA (Agência Nacional de Vigilância Sanitária)

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

ClinicalTrials.gov processed this record on May 23, 2013