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

Primary Purpose

Hepatitis C, Chronic

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

danoprevir

peginterferon alfa-2a [Pegasys]

placebo

ribavirin

ritonavir

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability: Adverse events, ECG, laboratory parameters

Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2

Antiviral activity: HCV RNA (COBAS Taqman HCV Test)

Secondary Outcome Measures

Viral resistance development

Effects on cytochrome P450(CYP)2C9 and 3A isozymes

Virological response in prior null-responders

Comparison of pharmacokinetics and antiviral activity between treatment-naïve patients and prior null-responders to standard of care treatment

Full Information

NCT ID

NCT01185860

First Posted

August 19, 2010

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01185860

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

danoprevir

Intervention Description

oral doses

Intervention Type

Drug

Intervention Name(s)

peginterferon alfa-2a [Pegasys]

Intervention Description

180 mcg sc once weekly

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

oral doses

Intervention Type

Drug

Intervention Name(s)

ribavirin

Intervention Description

1000-1200mg/day po

Intervention Type

Drug

Intervention Name(s)

ritonavir

Intervention Description

oral doses

Primary Outcome Measure Information:

Title

Safety and tolerability: Adverse events, ECG, laboratory parameters

Time Frame

approximately 3 years

Title

Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2

Time Frame

Days 3-9

Title

Antiviral activity: HCV RNA (COBAS Taqman HCV Test)

Time Frame

from baseline to Day 28

Secondary Outcome Measure Information:

Title

Viral resistance development

Time Frame

from baseline to Day 17

Title

Effects on cytochrome P450(CYP)2C9 and 3A isozymes

Time Frame

from baseline to Day 17

Title

Virological response in prior null-responders

Time Frame

from baseline to week 72

Title

Comparison of pharmacokinetics and antiviral activity between treatment-naïve patients and prior null-responders to standard of care treatment

Time Frame

approximately 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Montpellier

ZIP/Postal Code

34094

Country

France

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

City

Grafton

ZIP/Postal Code

1010

Country

New Zealand

City

Warszawa

ZIP/Postal Code

01-201

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

24295986

Citation

Gane EJ, Rouzier R, Wiercinska-Drapalo A, Larrey DG, Morcos PN, Brennan BJ, Le Pogam S, Najera I, Petric R, Tran JQ, Kulkarni R, Zhang Y, Smith P, Yetzer ES, Shulman NS. Efficacy and safety of danoprevir-ritonavir plus peginterferon alfa-2a-ribavirin in hepatitis C virus genotype 1 prior null responders. Antimicrob Agents Chemother. 2014;58(2):1136-45. doi: 10.1128/AAC.01515-13. Epub 2013 Dec 2.

Results Reference

derived

PubMed Identifier

23872824

Citation

Morcos PN, Chang L, Kulkarni R, Giraudon M, Shulman N, Brennan BJ, Smith PF, Tran JQ. A randomised study of the effect of danoprevir/ritonavir or ritonavir on substrates of cytochrome P450 (CYP) 3A and 2C9 in chronic hepatitis C patients using a drug cocktail. Eur J Clin Pharmacol. 2013 Nov;69(11):1939-49. doi: 10.1007/s00228-013-1556-y. Epub 2013 Jul 20.

Results Reference

derived

PubMed Identifier

21354234

Citation

Gane EJ, Rouzier R, Stedman C, Wiercinska-Drapalo A, Horban A, Chang L, Zhang Y, Sampeur P, Najera I, Smith P, Shulman NS, Tran JQ. Antiviral activity, safety, and pharmacokinetics of danoprevir/ritonavir plus PEG-IFN alpha-2a/RBV in hepatitis C patients. J Hepatol. 2011 Nov;55(5):972-9. doi: 10.1016/j.jhep.2011.01.046. Epub 2011 Feb 24.

Results Reference

derived

Learn more about this trial

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

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