A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4

Hepatitis C, Chronic Clinical Trial

Official title:

A Randomized, Double-blind, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination With Pegasys® and Ribavirin® (SOC) Versus SOC in Treatment-Naïve Patients With HCV Genotype 1 or 4 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869661
• Other study ID #: NV20536
• Secondary ID: 2008-008258-21
• Status: Completed
• Phase: Phase 2
• First received: March 25, 2009
• Last updated: November 1, 2016
• Start date: February 2001
• Est. completion date: February 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 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients in these 3 groups who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks, and group 5 will receive SOC for 48 weeks. Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The anticipated time on study treatment is 6-12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients, 18-65 years of age

• Chronic hepatitis C, genotype 1 or 4

• Treatment-naive

Exclusion Criteria:

• No previous treatment with any interferon- or ribavirin-based therapy

• Other forms of liver disease

• HIV infection

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 C
• Hepatitis C, Chronic

Intervention

Drug:
• Copegus
1000/1200mg po daily for 24 or 48 weeks
• Copegus
1000/1200mg po daily for 48 weeks
• Pegasys
180 micrograms sc weekly for 24 or 48 weeks
• Pegasys
180 micrograms sc weekly for 48 weeks
• RO5024048
1000mg bid for 24 weeks
• RO5024048
500mg bid for 12 weeks
• RO5024048
1000mg bid for 8 weeks
• RO5024048
1000mg bid for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany,  Italy,  Puerto Rico,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virologic response: Percentage of patients with undetectable Hepatitis C RNA level		24 weeks after end of treatment	No
Secondary	Virologic response: Percentage of patients with undetectable Hepatitis C RNA level		60 Weeks	No
Secondary	Virologic response: Percentage of patients with undetectable Hepatitis C RNA level		12 weeks post-treatment	No
Secondary	Relapse rate: Percentage of patients who achieved a virologic response at the end of treatment but had detectable Hepatitis C RNA level at the last assessment post treatment		72 weeks	No
Secondary	Safety: Incidence of adverse events		72 weeks	No