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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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1 May 2012 |
Main ID: |
EUCTR2004-001220-20-IT |
Date of registration:
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09/02/2007 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Efficacy and safety of PegIntron plus Rebetol in subjects with chronic hepatitis C genotype 1 non responder to Pegasys.
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Scientific title:
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Efficacy and safety of PegIntron plus Rebetol in subjects with chronic hepatitis C genotype 1 non responder to Pegasys. |
Date of first enrolment:
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16/11/2005 |
Target sample size:
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200 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001220-20 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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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: 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:
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis C genotype 1. MedDRA version: 6.1
Level: PT
Classification code 10019744
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Intervention(s)
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Trade Name: REBETOL*84CPS 200MG
Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ribavirin CAS Number: 36791-04-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Peginterferon alfa-2b CAS Number: 215647-85-1 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 1-
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Primary Outcome(s)
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Secondary Objective:
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Primary end point(s):
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Main Objective:
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Secondary ID(s)
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2004-001220-20-GB
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P03833
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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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