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A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01483742
Collaborator
(none)
43
Enrollment
27
Locations
2
Arms
17
Duration (Months)
1.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted DANOPREVIR and RO5024048 in Different Combinations in Null Responder or Treatment Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Combination without RO5024048

Ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients

Drug: danoprevir
100 mg orally bid, 24 weeks

Drug: peginterferon alfa-2a [Pegasys]
180 mcg weekly, 24 weeks

Drug: ribavirin
1000-1200 mg/kg/day orally in two divided doses, 24 weeks

Drug: ritonavir
100 mg orally bid, 24 weeks
Experimental: Combination with RO5024048

RO5024048 added to the combination treatment (ritonavir-boosted danoprevir in combination with Pegasys [peginterferon alfa-2a] and ribavirin) in prior null responder patients

Drug: RO5024048
1000 mg orally bid, 24 weeks

Drug: danoprevir
100 mg orally bid, 24 weeks

Drug: peginterferon alfa-2a [Pegasys]
180 mcg weekly, 24 weeks

Drug: ribavirin
1000-1200 mg/kg/day orally in two divided doses, 24 weeks

Drug: ritonavir
100 mg orally bid, 24 weeks

Outcome Measures

Primary Outcome Measures

  1. Safety: Incidence of adverse events [48 weeks]

  2. Pharmacokinetics (PK): Area under the concentration-time curve (AUC) [Intensive PK sample collection during initial 2 week dosing period, followed by routine sampling during treatment up to Week 24]

  3. Antiviral activity: Hepatitis C virus (HCV) RNA levels assessed by Roche COBAS Taqman HCV Test [48 weeks]

Secondary Outcome Measures

  1. Emergence of viral resistance: HCV RNA gene sequence variations [From baseline to Week 48]

  2. Virologic response: HCV RNA levels [approximately 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Adult patients, 18 to 65 years of age inclusive

  • Chronic hepatitis C, genotype 1 or 4

  • Cohort 1: Treatment-naïve for hepatitis C

  • Cohort 2: Prior null responder to treatment with approved doses of pegylated interferon plus ribavirin

  • Liver biopsy confirming cirrhosis

  • Compensated cirrhosis (Child-Pugh A)

Exclusion Criteria:

  • Pregnant or lactating women or male partners of women who are pregnant

  • History or presence of decompensated liver disease (ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices)

  • Cohort 2: Patients who discontinued previous pegylated interferon plus ribavirin treatment due to reasons other than null response

  • History of clinically significant cardiovascular or cerebrovascular disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Birmingham Alabama United States 35294
2 Anaheim California United States 92801
3 Coronado California United States 92118
4 La Jolla California United States 92037
5 Long Beach California United States 90807
6 DeLand Florida United States 32720
7 Miami Florida United States 33136
8 Orlando Florida United States 32803
9 Atlanta Georgia United States 30308
10 Atlanta Georgia United States 30309
11 New Orleans Louisiana United States 70112
12 Detroit Michigan United States 48202-2689
13 Hillsborough New Jersey United States 08844
14 New York New York United States 10021
15 San Antonio Texas United States 78215
16 Fitzroy South Australia Australia 3065
17 Melbourne Victoria Australia 3124
18 Vancouver British Columbia Canada V6Z 2C7
19 Toronto Ontario Canada M5G 2C4
20 Montpellier France 34094
21 Auckland New Zealand 1142
22 Christchurch New Zealand 8140
23 Chorzów Poland 41-500
24 Myslowice Poland 41-400
25 Warszawa Poland 02-507
26 Wrocław Poland 51-149
27 Bratislava Slovakia 833 05

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01483742
Other Study ID Numbers:
  • NP27946
  • 2011-004129-28
First Posted:
Dec 1, 2011
Last Update Posted:
Aug 1, 2016
Last Verified:
Jul 1, 2016
Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Ritonavir
Ribavirin
Peginterferon alfa-2a

Study Results

No Results Posted as of Aug 1, 2016