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CompletedNCT01679834Updated Mar 1, 2018

An Observational Study of Pegasys in Dual- or Triple-Therapy in Patients With Chronic Hepatitis C

An observational study in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Completed at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-01.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7,500
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 7,500 is above the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with chronic hepatitis C infection

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
7,500 participants (estimated)

Groups and cohorts

  • Cohort
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What researchers measure

Primary outcomes

  1. Sustained virological response

    Time frame: 24 weeks after end of treatment

Secondary outcomes

  1. Rapid virological response

    Time frame: 4 weeks after start of treatment

  2. Early Virological Response

    Time frame: 12 weeks after start of treatment

  3. Safety: incidence of adverse events

    Time frame: up to 24 weeks after end of treatment

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Study locations

2 sites
  • Hannover, 30625, Germany
  • Herne, 44623, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01679834
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Sep 6, 2012
Start date
Nov 24, 2014
Primary completion
Jul 14, 2017
Completion
Jul 14, 2017
Last update
Mar 1, 2018

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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