A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1

Hepatitis C, Chronic Clinical Trial

Official title:

A Multiple-Dose Study To Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted RO5190591 in Combination With Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185860
• Other study ID #: NP22660
• Secondary ID: 2009-012426-36
• Status: Completed
• Phase: Phase 1
• First received: August 19, 2010
• Last updated: November 1, 2016
• Start date: August 2009
• Est. completion date: January 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 study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults, 18-65 years of age

• Chronic hepatitis C genotype 1

• HCV treatment naïve, or without sustained virologic response on prior PEG-INF/RBV treatment

• Body mass index (BMI) 18 - 35 kg/m2, inclusive; minimum weight 45 kg

Exclusion Criteria:

• Liver cirrhosis

• Decompensated liver disease or impaired liver function

• Medical condition associated with chronic liver disease other than chronic hepatitis C

• Positive for hepatitis B or HIV infection at screening

• History of alcohol consumption exceeding 2 standard drinks per day when averaged over the course of a given week

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• danoprevir
oral doses
• peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly
• placebo
oral doses
• ribavirin
1000-1200mg/day po
• ritonavir
oral doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

France,  New Zealand,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability: Adverse events, ECG, laboratory parameters		approximately 3 years	No
Primary	Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2		Days 3-9	No
Primary	Antiviral activity: HCV RNA (COBAS Taqman HCV Test)		from baseline to Day 28	No
Secondary	Viral resistance development		from baseline to Day 17	No
Secondary	Effects on cytochrome P450(CYP)2C9 and 3A isozymes		from baseline to Day 17	No
Secondary	Virological response in prior null-responders		from baseline to week 72	No
Secondary	Comparison of pharmacokinetics and antiviral activity between treatment-naïve patients and prior null-responders to standard of care treatment		approximately 3 years	No