A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C

Hepatitis C, Chronic Clinical Trial

Official title:

A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Boceprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482403
• Other study ID #: NV27780
• Secondary ID: 2011-002714-37
• Status: Completed
• Phase: Phase 2
• First received: November 28, 2011
• Last updated: August 3, 2016
• Start date: November 2011
• Est. completion date: January 2014

Study information

• Verified date: August 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 randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/=18 years of age

• Chronic hepatitis C infection for at least 6 months duration

• Hepatitis C genotype 1a or 1b

• Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study

• Patient showed a previous null response to therapy as defined by < 2 log10 IU/mL decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Exclusion Criteria:

• Hepatitis C infection with a genotype other than genotype 1a or 1b

• Body mass index <18 or >/=36

• Hepatitis A, hepatitis B, or HIV infection

• Herbal remedies </=1 month prior to the first dose of study drug

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:
• Copegus
total daily dose of 1000 mg or 1200 mg for 24 weeks
• Copegus
total daily dose of 1000 mg or 1200 mg for 48 weeks
• Pegasys
180 microgram subcutaneous once a week for 24 weeks
• Pegasys
180 microgram subcutaneous once a week for 48 weeks
• boceprevir
800 mg three times a day for 24 weeks
• boceprevir
800 mg three times a day for 48 weeks
• mericitabine
1000 mg twice daily for 24 weeks
• mericitabine placebo
mericitabine placebo
• boceprevir placebo
boceprevir placebo
• boceprevir
800 mg three times a day for 44 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response 12 weeks after treatment (SVR-12)		up to 60 weeks	No
Secondary	Sustained virological response 4 weeks after treatment		up to 52 weeks	No
Secondary	Virologic response over time		60 weeks	No
Secondary	Proportion of patients who develop treatment resistance		60 weeks	No
Secondary	Safety (incidence of adverse events)		60 weeks	No
Secondary	Pharmacokinetics: trough concentration of RO4995855		Day 1 and Week 8	No
Secondary	Pharmacokinetics: trough concentration of RO5012433		Day 1 and Week 8	No
Secondary	Pharmacokinetics: trough concentration of boceprevir		Day 1 and Week 8	No