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

A Roche Project in Cooperation With the Bng (Association of German Resident Gastroenterologists) for Quality Assurance in the Dual- or Triple-therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa 2a (Pegasys) at Hepatology Centers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01679834

Enrollment

7500

Registered

2012-09-06

Start date

2014-11-24

Completion date

2017-07-14

Last updated

2018-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame
Sustained virological response	24 weeks after end of treatment

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results