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Register:	EUCTR
Last refreshed on:	7 January 2013
Main ID:	EUCTR2010-019584-10-IT
Date of registration:	24/12/2010
Prospective Registration:	No
Primary sponsor:	Hoffmann-La Roche
Public title:	A Randomized, Open label, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir (RO5190591) Boosted with Low Dose Ritonavir (danoprevir/r) in Combination with Pegasys and Copegus versus Pegasys and Copegus alone in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 or 4 Virus Infection - DAUPHINE
Scientific title:	A Randomized, Open label, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir (RO5190591) Boosted with Low Dose Ritonavir (danoprevir/r) in Combination with Pegasys and Copegus versus Pegasys and Copegus alone in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 or 4 Virus Infection - DAUPHINE
Date of first enrolment:	30/11/2010
Target sample size:	405
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019584-10
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: SOC (Pegasys + Copegus)
Phase:

Countries of recruitment
Austria	France	Italy	Spain	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
- Adults patients, >/=18 years of age - Chronic Hepatitis C, Genotype 1 and 4 - HCV RNA >/=50,000 IU/mL - treatment-naive
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients with cirrhosis or incomplete/transition to cirrhosis - Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac disease

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic Hepatitis C
MedDRA version: 9.1 Level: LLT Classification code 10008912

Intervention(s)

Product Name: Danoprevir
Product Code: RO519-0591/F24
Pharmaceutical Form: Tablet
Current Sponsor code: RO519-0591/F24
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: Danoprevir
Product Code: RO519-0591/F25
Pharmaceutical Form: Tablet
Current Sponsor code: RO519-0591/F25
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Norvir
Pharmaceutical Form: Tablet
INN or Proposed INN: Ritonavir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Pegasys
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Peginterferon alfa-2a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 180-

Trade Name: Copegus
Pharmaceutical Form: Tablet
INN or Proposed INN: Ribavirin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Primary end point(s): Sustained virological response 24 weeks after end of treatment.

Main Objective: To study the effects of different doses and durations of danoprevir/r treatment in combination with Pegasys and Copegus on the proportion of patients who achieve sustained virological response versus the currently approved combination of Pegasys and Copegus in treatment-naive patients with chronic hepatitis C genotype 1 or 4 virus infection.

Secondary Objective: - To evaluate the safety and tolerability of danoprevir/r in combination with Pegasys + Copegus versus Pegasys + Copegus alone. - To determine virologic response at scheduled visits over time. - To evaluate relapse rate. - To evaluate virological breakthrough (viral load rebound)rate. - To characterize the resistance. profile of RO5190591 when given in combination with Pegasys + Copegus. - To evaluate the pharmacokinetics of danoprevir/r when given in combination with Pegasys + Copegus.

Secondary Outcome(s)

Secondary ID(s)

2010-019584-10-ES

NV22776

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
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