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. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2012-004185-17-GB |
Date of registration:
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24/07/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Pharmacokinetics, pharmacodynamics and safety of DEB025/Alisporivir in combination with ribavirin therapy in chronic hepatitis C genotype 2 and 3 treatment naive patients
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Scientific title:
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A multicenter, open-label, randomized, 3-arm, phase II profiling trial of pharmacokinetics, pharmacodynamics and safety of DEB025/Alisporivir in combination with ribavirin therapy in chronic hepatitis C genotype 2 and 3 treatment naïve patients |
Date of first enrolment:
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16/10/2013 |
Target sample size:
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150 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004185-17 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no 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: no Number of treatment arms in the trial: 3
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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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Germany
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Poland
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Sweden
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United Kingdom
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Contacts
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Name:
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Medical Information Services
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Address:
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Frimley Business Park
GU16 7SR
Frimley, Camberley
United Kingdom |
Telephone:
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+441276698370 |
Email:
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medinfo.uk@novartis.com |
Affiliation:
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Novartis Pharmaceuticals UK Limited |
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Name:
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Medical Information Services
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Address:
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Frimley Business Park
GU16 7SR
Frimley, Camberley
United Kingdom |
Telephone:
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+441276698370 |
Email:
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medinfo.uk@novartis.com |
Affiliation:
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Novartis Pharmaceuticals UK Limited |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed.
2. No previous treatment for Hepatitis C infection (i.e. HCV treatment-naïve)
3. Chronic hepatitis C virus infection diagnosed
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 33 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria: 1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
3. History of pancreatitis or history strongly suggestive of previous pancreatitis
4. HBsAg positive or HIV positive.
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
MedDRA version: 16.1
Level: PT
Classification code 10008912
Term: Chronic hepatitis C
System Organ Class: 10021881 - Infections and infestations
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Therapeutic area: Diseases [C] - Virus Diseases [C02]
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Intervention(s)
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Trade Name: Copegus Pharmaceutical Form: Tablet INN or Proposed INN: Ribavirin CAS Number: 36791-04-5 Other descriptive name: RIBAVIRIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
Trade Name: Pegasys Pharmaceutical Form: Solution for injection INN or Proposed INN: peginterferon alpha 2a CAS Number: 198153-51-4 Other descriptive name: PEGINTERFERON ALFA-2A Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 180-
Product Name: alisporivir Product Code: DEB025 Pharmaceutical Form: Capsule, soft INN or Proposed INN: alisporivir CAS Number: 254435-95-5 Current Sponsor code: DEB025 Other descriptive name: ALISPORIVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
Product Name: alisporivir Product Code: DEB025 Pharmaceutical Form: Capsule, soft INN or Proposed INN: alisporivir CAS Number: 254435-95-5 Current Sponsor code: DEB025 Other descriptive name: ALISPORIVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
Trade Name: Copegus Pharmaceutical Form: Tablet INN or Proposed INN: Ribavirin CAS Number: 36791-04-5 Other descriptive name: RIBAVIRIN Concentration unit: mg milligram(s) Concentration type: equal Concentration n
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Primary Outcome(s)
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Main Objective: Pharmacodynamics, Pharmacokinetic, safety profiles between treatment groups receiving 3 different doses of DEB025 in combination with RBV
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Secondary Objective: Evaluate the SVR12 among 3 treatment groups with different doses of DEB025 in combination with ribavirin in chronic heptatitis C GT2 and 3 treatment naive patients
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Timepoint(s) of evaluation of this end point: treatment week 12
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Primary end point(s): •viral load drop from baseline through week 12 •changes in serum triglycerides from baseline through week 12 •proportion of patients who develop confirmed Stage II or greater hypertension (SBP =160 mm Hg or DBP =100 mm Hg). •changes in platelet count from baseline through week 12.
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Secondary Outcome(s)
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Secondary end point(s): HCV RNA viral load SVR12
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Timepoint(s) of evaluation of this end point: SVR 12
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Secondary ID(s)
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2012-004185-17-SE
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CDEB025A2222
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Ethics review
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Status: Approved
Approval date:
Contact:
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