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Main
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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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9 October 2012 |
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Main ID: |
EUCTR2010-020034-26-PL |
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Date of registration:
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13/10/2010 |
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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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Scientific title:
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A multicenter, randomized, open label, parallel-group phase IIB study on the efficacy and safety of oral regimens of DEB025 alone or in combination with ribavirin versus Standard of Care (peg-IFNa2a plus ribavirin) in treatment-naïve hepatitis C genotype 2 and 3 patients -
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Date of first enrolment:
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28/12/2010 |
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Target sample size:
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400 |
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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:2010-020034-26 |
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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: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Belgium
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Germany
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Italy
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Poland
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Key inclusion criteria are:
Written informed consent prior to any assessment;
Males or females aged =18 and = 70 years;
BMI between = 18 and = 36 kg/m2;
Chronic hepatitis C virus infection;
Plasma HCV RNA = 10000 IU/ml; no upper limit;
Infection with HCV genotype 2 or 3;
HCV treatment naïve;
Female patients of child bearing potential must have a negative pregnancy test at screening and immediately prior to first administration of study drug.
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) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Key exclusion criteria are:
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer;
Any contraindications to peg-IFNa2a and/or RBV treatment;
Active or suspected cancer, or a history of malignancy where the risk of recurrence is = 20% within 2 years;
HBsAg positive or HIV positive;
Elevated (>ULN) total bilirubin level at screening.
Gilbert’s disease.
Cirrhosis, decompensated liver disease or complicated portal hypertension;
Hepatocellular carcinoma;
Pregnant, nursing or lactating women or women of child-bearing potential UNLESS they are using two birth control methods;
Men whose female partners are pregnant or contemplating pregnancy. Fertile males UNLESS the patient and his partner agree to comply with acceptable contraception;
Ongoing or recent use of any other medication (including over the counter medication and herbal products) within 2 weeks before study start or within 5 drug half-lives of that medication (whichever is longer) that are known inhibitors/inducers of cytochrome 450 3A, substrates of cytochrome 450 3A, substrates of P-gp, or substrates/inhibitors of OATPs, MRP2 or BSEP;
Any other cause of relevant liver disease other than HCV;
History of moderate, severe, or uncontrolled psychiatric disease, especially depression.
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 2 and 3 patients
MedDRA version: 15.0
Level: LLT
Classification code 10008912
Term: Chronic hepatitis C
System Organ Class: 10021881 - Infections and infestations
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Intervention(s)
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Product Name: DEB025
Product Code: DEB025
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Alisporivir
CAS Number: 25443509505
Current Sponsor code: DEB025
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: Copegus
Product Name: Copegus
Pharmaceutical Form: Capsule
INN or Proposed INN: RIBAVIRIN
CAS Number: 36791-04-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: Pegasys
Product Name: Pegasys
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PEGINTERFERON ALFA 2A
CAS Number: 198153-51-4
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 180-
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Primary Outcome(s)
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Primary end point(s): Proportion of patients who achieve RVR with DEB025 600mg QD plus RBV 400 mg BID, DEB025 800 mg QD plus RBV 400 mg BID and DEB025 1000 mg QD treatment groups, in treatment-naïve chronic hepatitis C genotype 2/3 patients
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Secondary Objective: The key secondary objective is to evaluate the proportion of patients with RVR on interferon free treatment who also achieve SVR 24 in treatment-naïve chronic hepatitis C genotype 2/3 patients.
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Main Objective: To evaluate the proportion of patients who achieve RVR with DEB025 600mg QD plus RBV 400 mg BID, DEB025 800 mg QD plus RBV 400 mg BID and DEB025 1000 mg QD treatment groups, in treatment-naïve chronic hepatitis C genotype 2/3 patients.
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Secondary ID(s)
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2010-020034-26-DE
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CDEB025A2211
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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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URL:
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