NCT01671046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.4 years

First QC Date

August 20, 2012

Last Update Submit

November 1, 2016

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (2)

  • Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start

    24 months

  • Correlation of liver elasticity evolution with viral kinetics

    24 months

Secondary Outcomes (8)

  • Safety: incidence of adverse events

    24 months

  • Correlation of liver fibrosis stages with sustained virological response (SVR)

    24 months

  • Correlation of patients characteristics with sustained virological response

    24 months

  • Hepatic transient elastography (M-transducer)

    24 months

  • Hepatic transient elastography (XL-transducer)

    24 months

  • +3 more secondary outcomes

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic hepatitis C

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 20270-004, Brazil

Location

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil

Location

Unknown Facility

Botucatu, São Paulo, 18600-400, Brazil

Location

Unknown Facility

Campinas, São Paulo, 13026-210, Brazil

Location

Unknown Facility

Campinas, São Paulo, 13060-803, Brazil

Location

Unknown Facility

Santo André, São Paulo, 09060-650, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04040-002, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04040-003, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 05403-000, Brazil

Location

Unknown Facility

Sorocaba, São Paulo, 18047-600, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy of the liver

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2012

First Posted

August 23, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

BR(10)