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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01215643
Registration number
NCT01215643
Ethics application status
Date submitted
5/10/2010
Date registered
6/10/2010
Date last updated
30/08/2016
Titles & IDs
Public title
Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
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Scientific title
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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Secondary ID [1]
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2010-020034-26
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Secondary ID [2]
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CDEB025A2211
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C
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0
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Chronic Pain
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Condition category
Condition code
Infection
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0
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0
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Other infectious diseases
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Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Neurological
0
0
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0
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Other neurological disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Alisporivir
Treatment: Drugs - Peginterferon alfa-2a
Treatment: Drugs - Ribavirin
Experimental: ALV 1000 mg - Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
Experimental: ALV 600 mg+RBV - Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24.
Experimental: ALV 800 mg+RBV - Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
Experimental: ALV 600 mg+PEG - Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24.
Active comparator: PEG+RBV - Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.
Treatment: Drugs: Alisporivir
ALV 200 mg soft gel capsules administered orally
Treatment: Drugs: Peginterferon alfa-2a
PEG 180 µg administered via subcutaneous (s.c.) injection once weekly
Treatment: Drugs: Ribavirin
RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
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Assessment method [1]
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RVR4LOQ was defined as RVR \[serum hepatitis C virus (HCV) ribonucleic acid (RNA) \< the limit of quantification (LOQ), i.e., \< 25 IU/mL\], after 4 weeks of treatment.
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Timepoint [1]
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after 4 weeks of treatment
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Secondary outcome [1]
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Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
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Assessment method [1]
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RVR4LOD was defined as Rapid Viral Response (RVR) \[serum HCV RNA \< the limit of detection (LOD), i.e., \< 10 IU/mL\], after 4 weeks of treatment.
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Timepoint [1]
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after 4 weeks of treatment
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Secondary outcome [2]
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Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
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Assessment method [2]
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Timepoint [2]
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after 4 weeks of treatment
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Secondary outcome [3]
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Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
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Assessment method [3]
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Timepoint [3]
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after 4 weeks of treatment
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Secondary outcome [4]
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Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
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Assessment method [4]
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cEVR12LOQ and cEVR12LOD were defined as cEVR \[serum HCV RNA \< LOQ and \< LOD\] after 12 weeks of treatment, respectively.
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Timepoint [4]
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after 12 weeks of treatment
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Secondary outcome [5]
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Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
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Assessment method [5]
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Timepoint [5]
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after 12 weeks of treatment
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Secondary outcome [6]
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Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
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Assessment method [6]
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Timepoint [6]
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after 12 weeks of treatment
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Secondary outcome [7]
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Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
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Assessment method [7]
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ETR24LOQ and ETR24LOD were defined as ETR \[serum HCV RNA \< LOQ and \< LOD\] after 24 weeks of treatment or when prematurely discontinued.
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Timepoint [7]
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at end of treatment, within 24 weeks
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Secondary outcome [8]
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Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
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Assessment method [8]
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Timepoint [8]
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at end of treatment, within 24 weeks
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Secondary outcome [9]
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Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
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Assessment method [9]
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Timepoint [9]
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at end of treatment, within 24 weeks
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Secondary outcome [10]
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Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
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Assessment method [10]
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SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) \[serum HCV RNA \< LOQ and \< LOD\] 12 weeks after treatment, respectively.
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Timepoint [10]
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12 weeks after the end of treatment
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Secondary outcome [11]
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Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
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Assessment method [11]
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Timepoint [11]
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12 weeks after the end of treatment
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Secondary outcome [12]
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Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
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Assessment method [12]
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Timepoint [12]
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12 weeks after the end of treatment
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Secondary outcome [13]
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Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
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Assessment method [13]
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Timepoint [13]
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24 weeks after the end of treatment
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Secondary outcome [14]
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Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
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Assessment method [14]
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Timepoint [14]
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24 weeks after the end of treatment
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Secondary outcome [15]
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Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
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Assessment method [15]
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Timepoint [15]
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24 weeks after the end of treatment
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Secondary outcome [16]
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Percentage of Participants With On-treatment Viral Breakthrough
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Assessment method [16]
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Viral breakthrough was defined as either:
* Confirmed increase of HCV RNA =1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or
* HCV RNA becoming = 100 IU/mL after previously being undetectable (\< LOD) during treatment
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Timepoint [16]
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within 24 weeks of treatment
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Secondary outcome [17]
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Percentage of Participants With Viral Relapse
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Assessment method [17]
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Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (\< LOD) during treatment.
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Timepoint [17]
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within 24 weeks after the end of treatment
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Eligibility
Key inclusion criteria
Inclusion criteria:
* Chronic hepatitis C viral infection
* Plasma HCV RNA level lower limit = 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)
* HCV genotype 2 or 3
* No previous treatment for hepatitis C infection
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Minimum age
18
Years
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
* Evidence of cirrhosis at the time of screening
* Evidence of hepatocellular carcinoma at the time of screening
* Any other cause of relevant liver disease other than HCV
* Alanine aminotransferase (ALT) = 10 times upper limit of normal (ULN)
* Other protocol-defined inclusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2012
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Sample size
Target
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Accrual to date
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Final
340
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Kingswood
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Recruitment hospital [2]
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Novartis Investigative Site - Kogarah
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Recruitment hospital [3]
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Novartis Investigative Site - Westmead
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Recruitment hospital [4]
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Novartis Investigative Center - Greenslopes
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Recruitment hospital [5]
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Novartis Investigative Site - Clayton
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Recruitment hospital [6]
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Novartis Investigative Site - Fitzroy
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Recruitment postcode(s) [1]
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2747 - Kingswood
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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4120 - Greenslopes
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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3065 - Fitzroy
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Hawaii
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United States of America
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Kansas
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United States of America
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Massachusetts
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United States of America
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Missouri
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United States of America
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New Hampshire
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United States of America
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New York
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United States of America
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Texas
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Leuven
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Canada
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British Columbia
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Canada
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Ontario
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France
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Clichy Cedex
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France
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Creteil
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France
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Marseille
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France
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Paris
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Hannover
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Germany
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Leipzig
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India
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Kerala
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India
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Maharashtra
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India
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Punjab
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India
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Uttar Pradesh
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India
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Guwahati
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India
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Haryana
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India
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Hyderabad - Andhra Pradesh
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India
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Mumbai
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India
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New Delhi
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Pavia
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Italy
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Roma
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Italy
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Torino
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Korea, Republic of
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Pusan
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Korea, Republic of
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Seoul
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Poland
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Bialystok
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Poland
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Lódz
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Poland
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Warsaw
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Puerto Rico
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San Juan
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Taiwan
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Kaohsiung
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Taiwan
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State/province [44]
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Niaosong Township
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Yun-Lin
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Thailand
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Bangkok
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0
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Thailand
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Chiang Mai
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Thailand
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Songkla
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0
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United Kingdom
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Glasgow - Scotland
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United Kingdom
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London
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United Kingdom
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Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Debiopharm International SA
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.
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Trial website
https://clinicaltrials.gov/study/NCT01215643
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Trial related presentations / publications
Pawlotsky JM, Flisiak R, Sarin SK, Rasenack J, Piratvisuth T, Chuang WL, Peng CY, Foster GR, Shah S, Wedemeyer H, Hezode C, Zhang W, Wong KA, Li B, Avila C, Naoumov NV; VITAL-1 study team. Alisporivir plus ribavirin, interferon free or in combination with pegylated interferon, for hepatitis C virus genotype 2 or 3 infection. Hepatology. 2015 Oct;62(4):1013-23. doi: 10.1002/hep.27960. Epub 2015 Aug 10.
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
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Address
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Country
0
0
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Phone
0
0
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Fax
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0
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Email
0
0
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Pawlotsky JM, Flisiak R, Sarin SK, Rasenack J, Pir...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT01215643
Download to PDF