NCT01200225

Brief Summary

This prospective observational study will assess the insulin resistance and its impact on sustained virological response in patients with hepatitis C treated with Pegasys and Copegus. Data will be collected from each patient during the up to 72 weeks of treatment and for 24 weeks of treatment-free follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,155

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

February 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.3 years

First QC Date

September 10, 2010

Last Update Submit

November 1, 2016

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • Effect of insulin resistance, defined as HOMA index > 2, on sustained virological response (HCV RNA assessed by Polymerase Chain Reaction assay)

    42 months

Secondary Outcomes (6)

  • Host-, virus- and treatment-related factors influencing virological response and sustained virological response

    42 months

  • Parameters of metabolic syndrome

    42 months

  • Management of insulin resistance

    42 months

  • Quality of life: Hepatitis Quality of Life Questionnaire (HQLQ)

    42 months

  • Safety: Incidence of adverse events

    42 months

  • +1 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 inadequate response or intolerant to DMARDs and anti-TNF

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Chronic hepatitis C (detectable HCV RNA)
  • Initiation of treatment with Pegasys and Copegus

You may not qualify if:

  • Participation in a clinical trial during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neuilly-sur-Seine, 92521, France

Location

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

September 10, 2010

First Posted

September 13, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

FR(1)