A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C

Hepatitis C, Chronic Clinical Trial

Official title:

A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331850
• Other study ID #: WV21913
• Secondary ID: 2010-019585-90
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2011
• Last updated: November 1, 2016
• Start date: May 2011
• Est. completion date: January 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Comitato Etico Azienda Ospedalier Pisana-Toscana
• Study type: Interventional

Clinical Trial Summary

This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, age 18 years and older

• Presence of hepatitis C infection, genotype 1a or 1b

• Documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at least 12 weeks

• Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to study start

Exclusion Criteria:

• Infection with any hepatitis C genotype or subtype other than genotype 1a or 1b

• Patients with cirrhosis

• Patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than insufficient therapeutic response

• Co-infection with hepatitis B or human immunodeficiency virus (HIV)

• History or evidence of chronic liver disease other than hepatitis C

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
• Copegus
1000 mg or 1200 mg daily oral doses for 48 weeks
• Pegasys
180 microgram subcutaneously once weekly for 24 weeks
• Pegasys
180 microgram subcutaneously once weekly for 48 weeks
• RO5024048
1000 mg oral doses twice a day for 24 weeks
• danoprevir
100 mg oral doses twice a day for 24 weeks
• ritonavir
100 mg oral doses twice a day for 24 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,  Brazil,  Canada,  France,  Germany,  Italy,  Mexico,  Poland,  Puerto Rico,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response (SVR) of danoprevir/ritonavir with RO5024048 and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment		24 weeks	No
Primary	Sustained virological response (SVR) of danoprevir/ritonavir with Pegasys and Copegus in patients with previous partial response to peginterferon/ribavirin treatment		24 weeks	No
Primary	Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment		24 weeks	No
Primary	Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus followed by 24 weeks of Pegasys and Copegus treatment in patients with previous null response to peginterferon/ribavirin treatment		48 weeks	No
Secondary	Safety (Incidence of adverse events) of danoprevir, RO5024048 and Copegus		48 weeks	No
Secondary	Safety (Incidence of adverse events) of danoprevir, Pegasys and Copegus		48 weeks	No
Secondary	Safety (Incidence of adverse events) of danoprevir, RO5024048, Pegasys and Copegus		72 weeks	No
Secondary	Virological response over time		48 weeks	No
Secondary	Change in danoprevir plasma concentration		24 weeks	No
Secondary	Change in RO5024048 plasma concentration		24 weeks	No
Secondary	Hepatitis C virus drug resistance profile		24 weeks	No