NCT01679834

Brief Summary

This multicenter, observational study will assess the efficacy and the safety of Pegasys (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C. Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local guidelines. 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
7,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
2.2 years until next milestone

Study Start

First participant enrolled

November 24, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2017

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

2.6 years

First QC Date

September 3, 2012

Last Update Submit

February 27, 2018

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • Sustained virological response

    24 weeks after end of treatment

Secondary Outcomes (3)

  • Rapid virological response

    4 weeks after start of treatment

  • Early Virological Response

    12 weeks after start of treatment

  • Safety: incidence of adverse events

    up to 24 weeks after end of treatment

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 infection

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Diagnosis of chronic hepatitis C
  • Patients receiving treatment with Pegasys and/or Copegus (ribavirin) and/or a protease inhibitor according to local label

You may not qualify if:

  • Contraindications against Pegasys or Copegus
  • Not willing or unable to sign written informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Hanover, 30625, Germany

Location

Unknown Facility

Herne, 44623, Germany

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 3, 2012

First Posted

September 6, 2012

Study Start

November 24, 2014

Primary Completion

July 14, 2017

Study Completion

July 14, 2017

Last Updated

March 1, 2018

Record last verified: 2018-02

Locations

DE(2)