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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01318694
Registration number
NCT01318694
Ethics application status
Date submitted
17/03/2011
Date registered
18/03/2011
Date last updated
30/09/2016
Titles & IDs
Public title
Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants
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Scientific title
A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNa2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients
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Secondary ID [1]
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2010-022867-37
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Secondary ID [2]
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CDEB025A2301
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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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Condition category
Condition code
Infection
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0
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Other infectious diseases
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Oral and Gastrointestinal
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0
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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 - ALV Placebo
Experimental: Treatment Arm A - Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT):
Participants with a viral load below the level of detection (< LOD) at Week 4 stop study treatment after 24 weeks
Participants with a viral load = LOD at Week 4 complete 48 weeks of study treatment
Experimental: Treatment Arm B - Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
Experimental: Treatment Arm C - Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks
Active Comparator: Treatment Arm D - ALV Placebo with PEG and RBV for 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: ALV 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 Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)
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Assessment method [1]
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SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.
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Timepoint [1]
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12 weeks after the end of treatment
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Secondary outcome [1]
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Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)
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Assessment method [1]
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SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.
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Timepoint [1]
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24 weeks after the end of treatment
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Secondary outcome [2]
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Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)
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Assessment method [2]
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RVR4 was defined as serum HCV RNA < LOQ after 4 weeks of treatment.
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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 Early Virologic Response (EVR) After 12 Weeks of Treatment
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Assessment method [3]
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EVR was defined as a = 2 log10 decrease in HCV RNA or HCV RNA < LOQ after 12 weeks of treatment.
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Timepoint [3]
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after 12 weeks of treatment
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Secondary outcome [4]
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Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment
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Assessment method [4]
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pEVR was defined as a = 2 log10 decrease in HCV RNA and still detectable (= LOQ) after 12 weeks of treatment.
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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 Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment
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Assessment method [5]
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cEVR was defined as serum HCV RNA < LOQ after 12 weeks of treatment.
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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 Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment
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Assessment method [6]
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eRVR was defined as achieving RVR4 and maintaining HCV RNA < LOQ until Week 12.
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Timepoint [6]
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from 4 to 12 weeks of treatment
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Secondary outcome [7]
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Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks
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Assessment method [7]
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ETR was defined as serum HCV RNA < LOQ at treatment end (completed or prematurely discontinued).
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Timepoint [7]
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at treatment end within 48 weeks
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Secondary outcome [8]
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Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks
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Assessment method [8]
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ALT abnormalities were summarized as participants who had either:
ALT > 2 x upper limit of normal (ULN) during the study and > 2 x ULN at baseline
ALT > 3 x ULN during the study and > 2 x ULN at baseline
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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 Grade 3 or 4 Anemia During Treatment Within 48 Weeks
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Assessment method [9]
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Grading was according to the Modified Division of Microbiology & Infectious Diseases (DMID) Toxicity Tables (version 2.0).
Participants with multiple abnormalities were counted only once in the worst category.
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Timepoint [9]
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within 48 weeks
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Secondary outcome [10]
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Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks
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Assessment method [10]
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Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.
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Timepoint [10]
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within 48 weeks
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Secondary outcome [11]
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Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks
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Assessment method [11]
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Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.
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Timepoint [11]
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within 48 weeks
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Chronic HCV infection
- HCV genotype 1
- No previous treatment for hepatitis C infection
- Serum HCV RNA level = 1000 IU/ml assessed by quantitative polymerase chain reaction or
equivalent at screening, no upper limit
- Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6
months
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Minimum age
18
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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:
- HCV genotype different from genotype 1 or co-infection with other HCV genotype
- Co-infection with Hepatitis B or HIV
- Any other cause of relevant liver disease other than HCV
- Presence or history of hepatic decompensation
- Alanine aminotransferase (ALT) = 10 times upper limit of normal (ULN), more than 1
episode of elevated bilirubin (> ULN) in past 6 months
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 3
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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
1/03/2011
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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
1/08/2013
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Sample size
Target
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Accrual to date
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Final
1081
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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 - Darlinghurst
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Recruitment hospital [2]
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Novartis Investigative Site - Kingswood
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Novartis Investigative Site - Kogarah
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Novartis Investigative Site - Westmead
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Recruitment hospital [5]
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Novartis Investigative Site - Greenslopes
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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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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2747 - Kingswood
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment postcode(s) [5]
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4120 - Greenslopes
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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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Romania
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Iasi
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Madrid
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Birmingham
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London
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Vietnam
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Hanoi
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Vietnam
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Ho Chi Minh
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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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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy
[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment
in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01318694
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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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Phone
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01318694
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