A research study of a new medicine, danoprevir (also known as RO5190591) with ritonavir (also known as NORVIR®) in combination with Pegasys® (also known as PEG-IFN alfa-2a) and Copegus® (also known as ribavirin) for the treatment of a disease called chronic hepatitis C which causes damage to the liver.

• Register: EUCTR
• Last refreshed on: 28 January 2013
• Main ID: EUCTR2010-019584-10-AT
• Date of registration: 30/08/2010
• Prospective Registration: Yes
• Primary sponsor: F.Hoffmann-La Roche
• Public title: A research study of a new medicine, danoprevir (also known as RO5190591) with ritonavir (also known as NORVIR®) in combination with Pegasys® (also known as PEG-IFN alfa-2a) and Copegus® (also known as ribavirin) for the treatment of a disease called chronic hepatitis C which causes damage to the liver.
• 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.
• Date of first enrolment: 20/10/2010
• 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) Number of treatment arms in the trial: 5

Countries of recruitment

Austria, France, Italy, Spain, United Kingdom

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd.

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd.

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 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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: 14.0 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Product Name: Danoprevir
Product Code: RO519-0591/ F24
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Danoprevir
Current Sponsor code: RO519-0591/ F24
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Norvir
Product Name: Norvir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Current Sponsor code: RO032-6047
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100 -

Trade Name: Pegasys
Product Name: Pegasys
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PEGINTERFERON ALFA 2A
CAS Number: 198153-51-4
Current Sponsor code: R025-8310/J13
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 180-

Trade Name: Copegus
Product Name: Copegus
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIBAVIRIN
CAS Number: 36791-04-5
Current Sponsor code: R020-9963/F06
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Product Name: Danoprevir
Product Code: RO519-0591/ F25
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Danoprevir
Current Sponsor code: RO519-0591/ F25
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Primary end point(s): - Sustained virological response 24 weeks after end of treatment
- 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 (SVR) versus the currently approved combination of Pegasys® and Copegus® in treatment-naive patients with chronic hepatitis C genotype 1 and 4 virus infection

Timepoint(s) of evaluation of this end point: 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
• To determine virological response at scheduled clinical visits over time
• To evaluate relapse rate
• To characterise the resistance profile
• To evaluate the pharmacokinetics of danoprevir/r when given in combination with Pegasys® and Copegus

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1.Visits over time throughout entire study (week 48 plus 12 weeks treatment free follow up)
2.Visits over time throughout entire study (week 48 plus 24 weeks treatment free follow up)
3.Visits over time throughout entire study (week 48 plus 24 weeks treatment free follow up)
4.Visits over time throughout entire study (week 48 plus 24 weeks treatment free follow up)
5.Intense PK at weeks 4 and 8, sparse PK at clinic visits up to week 24

Secondary end point(s): -To evaluate the safety and tolerability of danoprevir/r in combination with Pegasys® and Copegus® versus Pegasys® and Copegus® alone.
-To determine virological response at scheduled clinical visits over time
-To evaluate relapse rate
-To characterise the resistance profile of danoprevir when danoprevir/r is given in combination with Pegasys® and Copegus®.
-To evaluate the pharmacokinetics of danoprevir/r when given in combination with Pegasys® and Copegus®.

Secondary ID(s)

2010-019584-10-ES

NV22776

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd.