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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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13 December 2021 |
Main ID: |
EUCTR2010-019584-10-FR |
Date of registration:
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06/09/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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:
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13/10/2010 |
Target sample size:
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405 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019584-10 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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)
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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France
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Germany
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Italy
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Spain
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United Kingdom
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Key inclusion & exclusion criteria
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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:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis C MedDRA version: 12.1
Level: LLT
Classification code 10008912
Term: Chronic hepatitis C
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Intervention(s)
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Product Name: Danoprevir Product Code: RO519-0591/ F24 Pharmaceutical Form: 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 Pharmaceutical Form: 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 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 Pharmaceutical Form: 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: Tablet INN or Proposed INN: Danoprevir Current Sponsor code: RO519-0591/ F25 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
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Primary Outcome(s)
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Secondary Objective: - To evaluate the safety and tolerability - 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 - To evaluate the pharmacokinetics of danoprevir/r when given in combination with Pegasys and Copegus
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Primary end point(s): - Sustained virological response 24 weeks after end of treatment
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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.
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Secondary ID(s)
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2010-019584-10-ES
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NV22776
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 22/09/2010
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