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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
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
Secondary ID [1] 0 0
2010-020033-14
Secondary ID [2] 0 0
CDEB025A2210
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
Timepoint [1] 0 0
after 12 weeks of treatment
Secondary outcome [1] 0 0
Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)
Timepoint [1] 0 0
after 12 weeks of treatment
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
Timepoint [2] 0 0
12 weeks after treatment
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
Timepoint [3] 0 0
24 weeks after treatment
Secondary outcome [4] 0 0
Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
Timepoint [4] 0 0
after 4 weeks of treatment
Secondary outcome [5] 0 0
Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
Timepoint [5] 0 0
after 12 weeks of treatment
Secondary outcome [6] 0 0
Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD
Timepoint [6] 0 0
within 48 weeks
Secondary outcome [7] 0 0
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
Timepoint [7] 0 0
Up to 48 weeks
Secondary outcome [8] 0 0
Percentage of Participants With On-treatment Viral Breakthrough
Timepoint [8] 0 0
within 48 weeks
Secondary outcome [9] 0 0
Percentage of Participants With Viral Relapse
Timepoint [9] 0 0
within 24 weeks after treatment

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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
459
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Kingswood
Recruitment hospital [2] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [3] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [4] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [5] 0 0
Novartis Investigative Site - Fitzroy
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Belgium
State/province [10] 0 0
Bruxelles
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
France
State/province [12] 0 0
Nice Cedex 3
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Frankfurt
Country [16] 0 0
Germany
State/province [16] 0 0
Freiburg
Country [17] 0 0
Germany
State/province [17] 0 0
Hamburg
Country [18] 0 0
Germany
State/province [18] 0 0
Köln
Country [19] 0 0
Germany
State/province [19] 0 0
Leipzig
Country [20] 0 0
Hungary
State/province [20] 0 0
Bekescsaba
Country [21] 0 0
Hungary
State/province [21] 0 0
Budapest
Country [22] 0 0
Hungary
State/province [22] 0 0
Debrecen
Country [23] 0 0
Hungary
State/province [23] 0 0
Kaposvár
Country [24] 0 0
Hungary
State/province [24] 0 0
Szekesfehervar
Country [25] 0 0
Italy
State/province [25] 0 0
FI
Country [26] 0 0
Italy
State/province [26] 0 0
PA
Country [27] 0 0
Italy
State/province [27] 0 0
PD
Country [28] 0 0
Italy
State/province [28] 0 0
PR
Country [29] 0 0
Italy
State/province [29] 0 0
RM
Country [30] 0 0
Italy
State/province [30] 0 0
Bologna
Country [31] 0 0
Poland
State/province [31] 0 0
Bialystok
Country [32] 0 0
Poland
State/province [32] 0 0
Lódz
Country [33] 0 0
Poland
State/province [33] 0 0
Warszawa
Country [34] 0 0
Puerto Rico
State/province [34] 0 0
San Juan
Country [35] 0 0
Romania
State/province [35] 0 0
District 1
Country [36] 0 0
Romania
State/province [36] 0 0
District 3
Country [37] 0 0
Romania
State/province [37] 0 0
Bucharest
Country [38] 0 0
Romania
State/province [38] 0 0
Iasi
Country [39] 0 0
Spain
State/province [39] 0 0
Andalucia
Country [40] 0 0
Spain
State/province [40] 0 0
Catalunya
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Spain
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Madrid
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Taiwan
State/province [42] 0 0
Taiwan, ROC
Country [43] 0 0
Taiwan
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Kaohsiung
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Taiwan
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Keelung City
Country [45] 0 0
Taiwan
State/province [45] 0 0
Lin-Ko
Country [46] 0 0
Taiwan
State/province [46] 0 0
Niaosong Township
Country [47] 0 0
Taiwan
State/province [47] 0 0
Taipei
Country [48] 0 0
Taiwan
State/province [48] 0 0
Yun-Lin
Country [49] 0 0
Turkey
State/province [49] 0 0
Ankara
Country [50] 0 0
Turkey
State/province [50] 0 0
Fatih / Istanbul
Country [51] 0 0
Turkey
State/province [51] 0 0
Izmir
Country [52] 0 0
United Kingdom
State/province [52] 0 0
London
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Debiopharm International SA
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01183169
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01183169