A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4

Hepatitis C, Chronic Clinical Trial

Official title:

A Randomized, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 or 4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057667
• Other study ID #: NV22621
• Status: Completed
• Phase: Phase 2
• First received: January 26, 2010
• Last updated: November 1, 2016
• Start date: February 2010
• Est. completion date: April 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-70 years of age

• hepatitis C, genotype 1 or 4, of over 6 months duration

• treatment-naïve

• negative pregnancy test; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Exclusion Criteria:

• pregnant or breast feeding females or male partners of pregnant females

• previous interferon or ribavirin based therapy or investigational anti-HCV agent

• systemic antiviral therapy with established or perceived activity against HCV </=3 months prior to first dose of study drug

• hepatitis A or B, or HIV infection

• history or evidence of medical condition associated with chronic liver disease other than HCV

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• RO5024048
1000mg bid po, 24 weeks
• Ribavirin [Copegus]
1000mg or 1200mg po daily
• peginterferon alfa-2a [Pegasys]
180mcg sc weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test)		24 weeks after last treatment dose	No
Secondary	Virologic response over time		weeks 4, 12, 24, 36, 48 and 60	No
Secondary	Pharmacokinetics of RO4995855 when RO5024048 is administered with peginterferon alfa-2a and ribavirin		week 12 and 24	No
Secondary	Resistance profile of RO5024048		weeks 1-24	No