An international, multicenter study evaluating cure rate and safety with Boceprevir in triple combination therapy with Peginterferon alfa-2a (40KD) and Ribavirin in previously untreated patients with genotype 1 chronic hepatitis C.

An international, multicenter, open-label study evaluating sustained virological response and safety with Boceprevir in triple combination therapy with Peginterferon alfa-2a (40KD) and Ribavirin in treatment-naïve patients with genotype 1 chronic hepatitis C. - TRICO

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004810-41-AT

Enrollment

150

Registered

2012-02-17

Start date

2012-04-18

Completion date

Unknown

Last updated

2014-08-05

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

Conditions

Genotype 1 CHC virus infection MedDRA version: 16.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Pegasys® Pharmaceutical Form: Solution for injection INN or Proposed INN: PEGINTERFERON ALFA-2A CAS Number: 198153-51-4 Current Sponsor code: Ro 025-8310 Other descriptive name: pegylated

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Treatment-naïve adult women and men with chronic hepatitis C monoinfection, genotype 1 and compensated liver disease including cirrhosis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 142 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: - Women with ongoing pregnancy or breast feeding - Male partners of women who are pregnant

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of boceprevir in triple combination therapy with peginterferon alfa-2a and ribavirin given as response guided treatment regimen (total of 28 or 48 treatment weeks) on the clearance of HCV 12 weeks after treatment end (sustained virological response) in treatment-naïve patients with genotype 1 chronic HCV infection;Secondary Objective: - To assess the effect of the triple combination regimen on the reduction of HCV viremia after 4, 8, 12, and 24 weeks of triple therapy, at end of therapy and 24 weeks after end of therapy - To assess the correlation between Interleukin 28B genotypes and virological response - To compare the virological response to triple therapy of genotype 1a vs. 1b - To assess the effect of cirrhosis and fibrosis on the virological response to triple therapy - Viral resistance profile - Safety profile of triple therapy - To assess the correlation between inosine triphosphatase (ITPA) and Hb decline ;Primary end point(s): Sustained virological response rate;Timepoint(s) of evaluation of this end point: 12 weeks after treatment end	—

Measure

Time frame

Main Objective: To evaluate the efficacy of boceprevir in triple combination therapy with peginterferon alfa-2a and ribavirin given as response guided treatment regimen (total of 28 or 48 treatment weeks) on the clearance of HCV 12 weeks after treatment end (sustained virological response) in treatment-naïve patients with genotype 1 chronic HCV infection;Secondary Objective: - To assess the effect of the triple combination regimen on the reduction of HCV viremia after 4, 8, 12, and 24 weeks of triple therapy, at end of therapy and 24 weeks after end of therapy - To assess the correlation between Interleukin 28B genotypes and virological response - To compare the virological response to triple therapy of genotype 1a vs. 1b - To assess the effect of cirrhosis and fibrosis on the virological response to triple therapy - Viral resistance profile - Safety profile of triple therapy - To assess the correlation between inosine triphosphatase (ITPA) and Hb decline ;Primary end point(s): Sustained virological response rate;Timepoint(s) of evaluation of this end point: 12 weeks after treatment end

—

Secondary

Measure	Time frame
Secondary end point(s): HCV RNA;Timepoint(s) of evaluation of this end point: Treatment weeks 4, 8, 12, 24, at end of therapy and 24 weeks after end of therapy	—

Countries

Austria, Brazil, Germany, Hungary, Poland, Romania, Spain

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026