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NCT Number: NCT01671046

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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rio de Janeiro, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 23, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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