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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01183169
Registration number
NCT01183169
Ethics application status
Date submitted
16/08/2010
Date registered
17/08/2010
Date last updated
25/08/2016
Titles & IDs
Public title
Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment
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Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment
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Secondary ID [1]
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2010-020033-14
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Secondary ID [2]
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CDEB025A2210
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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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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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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
Treatment: Drugs - Placebo
Experimental: Treatment A: ALV 600 mg QD - Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks
Experimental: Treatment B: ALV 800 mg QD - Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks
Experimental: Treatment C1: ALV Placebo - 600 mg QD - ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.
Experimental: Treatment C2: ALV Placebo - 400 mg BID - ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
Experimental: Treatment D: ALV 400 mg BID - Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks
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 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; = 75 kg = 1200 mg/day) administered orally in a divided daily dose
Treatment: Drugs: Placebo
ALV placebo soft gel capsules administered orally
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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 Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
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Assessment method [1]
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cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (\< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
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Timepoint [1]
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after 12 weeks of treatment
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Secondary outcome [1]
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Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)
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Assessment method [1]
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cEVR-LOD was defined as serum HCV RNA below the limit of detection (\< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
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Timepoint [1]
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after 12 weeks of treatment
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Secondary outcome [2]
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Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
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Assessment method [2]
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SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD 12 weeks after treatment, respectively.
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Timepoint [2]
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12 weeks after treatment
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Secondary outcome [3]
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Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
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Assessment method [3]
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SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD 24 weeks after treatment, respectively.
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Timepoint [3]
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24 weeks after treatment
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Secondary outcome [4]
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Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
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Assessment method [4]
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RVR-LOQ and RVR-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.
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Timepoint [4]
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after 4 weeks of treatment
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Secondary outcome [5]
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Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
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Assessment method [5]
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pEVR-LOQ and pEVR-LOD were defined as a = 2 log10 decrease in HCV RNA and still detectable (= LOQ and = LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
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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 End of Treatment Response (ETR)-LOQ and ETR-LOD
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Assessment method [6]
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ETR-LOQ and ETR-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD at treatment end (completed or prematurely discontinued), respectively.
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Timepoint [6]
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within 48 weeks
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Secondary outcome [7]
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Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
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Assessment method [7]
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Timepoint [7]
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Up to 48 weeks
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Secondary outcome [8]
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Percentage of Participants With On-treatment Viral Breakthrough
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Assessment method [8]
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On-treatment 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 (\< LOQ) during treatment
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Timepoint [8]
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within 48 weeks
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Secondary outcome [9]
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Percentage of Participants With Viral Relapse
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Assessment method [9]
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Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (\< LOQ) during treatment.
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Timepoint [9]
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within 24 weeks after treatment
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Eligibility
Key inclusion criteria
Inclusion criteria:
* Chronic HCV genotype 1 viral infection
* HCV RNA = 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening
* Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks
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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:
* Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening
* Women of child-bearing potential unless using highly effective
* Any other cause of relevant liver disease other than HCV
* 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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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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
1/08/2010
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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
1/05/2013
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Sample size
Target
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Accrual to date
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Final
459
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Recruitment in Australia
Recruitment state(s)
NSW,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 Site - Clayton
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Recruitment hospital [5]
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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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3168 - Clayton
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Recruitment postcode(s) [5]
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3065 - Fitzroy
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Recruitment outside Australia
Country [1]
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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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Florida
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United States of America
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Hawaii
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Illinois
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Kansas
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Massachusetts
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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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Leuven
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France
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Nice Cedex 3
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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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Hamburg
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Germany
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Köln
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Germany
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Leipzig
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Hungary
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Bekescsaba
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Budapest
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Debrecen
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Kaposvár
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Hungary
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Szekesfehervar
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Italy
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FI
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Italy
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PA
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Italy
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PD
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Italy
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Italy
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Bologna
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Bialystok
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Lódz
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Warszawa
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San Juan
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Romania
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District 1
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Romania
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Romania
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Bucharest
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Romania
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Iasi
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Spain
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Catalunya
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Spain
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Madrid
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Taiwan
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Taiwan, ROC
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Taiwan
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Kaohsiung
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Taiwan
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Keelung City
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Taiwan
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Lin-Ko
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Taiwan
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Niaosong Township
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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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Turkey
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Ankara
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Turkey
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Fatih / Istanbul
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Turkey
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Izmir
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United Kingdom
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London
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United Kingdom
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Nottingham
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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 participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.
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Trial website
https://clinicaltrials.gov/study/NCT01183169
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Email
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Contact person for public queries
Name
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Email
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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
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01183169
Download to PDF