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A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C

NCT01591460 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2016-11-02

Study results available
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Summary

This open-label, multicenter, treatment response guided study will evaluate the sustained virological response and safety of the triple combination therapy boceprevir, Pegasys (peginterferon alfa-2a) and Copegus (Ribavirin) in previously untreated patients with genotype 1 chronic hepatitis C. In the lead-in phase, patients will receive a dual combination therapy of Pegasys and Copegus for 4 weeks. In the following triple combination therapy phase, 800 mg boceprevir, 180 mcg Pegasys and 1000-1200 mg Copegus will be administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment response. The anticipated time on study treatment is up to 48 weeks.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

boceprevir

800 mg three times daily for 24, 32 or 44 weeks

DRUG

peginterferon alfa-2a [Pegasys]

180 mcg subcutaneously once a week for 24, 32 or 44 weeks

DRUG

peginterferon alfa-2a [Pegasys]

180 mcg subcutaneously once a week for 4 weeks

DRUG

ribavirin (Copegus]

1000 mg or 1200 mg orally once a day for 24, 32 or 44 weeks

DRUG

ribavirin (Copegus]

1000 mg or 1200 mg orally once a day for 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Austria
  • Germany
  • Hungary
  • Poland
  • Romania
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01591460 on ClinicalTrials.gov