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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. |
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Register:
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EUCTR |
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Last refreshed on:
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17 November 2014 |
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Main ID: |
EUCTR2010-019584-10-ES |
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Date of registration:
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18/08/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Estudio aleatorizado, abierto, multicéntrico, de búsqueda de dosis y duración del tratamiento para evaluar la respuesta virológica mantenida del inhibidor de proteasa VHC Danoprevir (RO5190591) reforzado con Ritonavir en dosis bajas (danoprevir/r) en asociación con Pegasys® y Copegus® comparado con la asociación Pegasys® y Copegus® en pacientes sin tratamiento previo con infección crónica por el virus de la hepatitis C genotipo 1 ó 4.
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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Estudio aleatorizado, abierto, multicéntrico, de búsqueda de dosis y duración del tratamiento para evaluar la respuesta virológica mantenida del inhibidor de proteasa VHC Danoprevir (RO5190591) reforzado con Ritonavir en dosis bajas (danoprevir/r) en asociación con Pegasys® y Copegus® comparado con la asociación Pegasys® y Copegus® en pacientes sin tratamiento previo con infección crónica por el virus de la hepatitis C genotipo 1 ó 4.
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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Date of first enrolment:
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16/12/2010 |
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Target sample size:
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405 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019584-10 |
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Study type:
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Interventional clinical trial of medicinal product |
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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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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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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Pacientes adultos, >/=18 años
- Hepatitis C crónica, Genotipo 1 y 4
- ARN VHC >/=50.000 UI/mL
- Sin tratamiento previo
- 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:
- Pacientes con cirrosis o cirrosis incompleta o transición a cirrosis.
- Pacientes con otras formas de hepatopatías, infección por VIH, carcinoma hepatocelular o cardiopatía grave.
- 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
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Health Condition(s) or Problem(s) studied
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Hepatitis C Crónica
MedDRA version: 13
Level: LLT
Classification code 10008912
Term: Hepatitis C crónica
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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 200 mg comprimidos recubiertos con película
Pharmaceutical Form: Tablet
INN or Proposed INN: RIBAVIRINA
CAS Number: 36791-04-5
Other descriptive name: RIBAVIRIN
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-
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: 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-
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Primary Outcome(s)
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Secondary Objective: - Evaluar la seguridad y tolerabilidad.
- Determinar la respuesta virológica en visitas
programadas a lo largo del tiempo.
- Evaluar la tasa de recidiva.
- Evaluar la tasa de recaída virológica (aumento de la
viremia) durante el tratamiento.
- Caracterizar el perfil de resistencia.
- Evaluar la farmacocinética de danoprevir/r cuando se asocia con Pegasys y Copegus.
- 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): - Respuesta viral sostenida 24 semanas después del final del tratamiento.
- Sustained virological response 24 weeks after end of treatment
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Main Objective: Estudiar los efectos de las diferentes dosis y duraciones del tratamiento con danoprevir/r en asociación con Pegasys® y Copegus® sobre la proporción de pacientes que consiguen respuesta virológica mantenida comparado con la asociación aprobada actualmente de Pegasys® y Copegus® en pacientes sin tratamiento previo con infección crónica por el virus de la hepatitis C genotipo 1 ó 4.
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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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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