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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/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
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
Secondary ID [1] 0 0
2010-020034-26
Secondary ID [2] 0 0
CDEB025A2211
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Chronic Pain 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
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
Timepoint [1] 0 0
after 4 weeks of treatment
Secondary outcome [1] 0 0
Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
Timepoint [1] 0 0
after 4 weeks of treatment
Secondary outcome [2] 0 0
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
Timepoint [2] 0 0
after 4 weeks of treatment
Secondary outcome [3] 0 0
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
Timepoint [3] 0 0
after 4 weeks of treatment
Secondary outcome [4] 0 0
Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
Timepoint [4] 0 0
after 12 weeks of treatment
Secondary outcome [5] 0 0
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
Timepoint [5] 0 0
after 12 weeks of treatment
Secondary outcome [6] 0 0
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
Timepoint [6] 0 0
after 12 weeks of treatment
Secondary outcome [7] 0 0
Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
Timepoint [7] 0 0
at end of treatment, within 24 weeks
Secondary outcome [8] 0 0
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
Timepoint [8] 0 0
at end of treatment, within 24 weeks
Secondary outcome [9] 0 0
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
Timepoint [9] 0 0
at end of treatment, within 24 weeks
Secondary outcome [10] 0 0
Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
Timepoint [10] 0 0
12 weeks after the end of treatment
Secondary outcome [11] 0 0
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
Timepoint [11] 0 0
12 weeks after the end of treatment
Secondary outcome [12] 0 0
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
Timepoint [12] 0 0
12 weeks after the end of treatment
Secondary outcome [13] 0 0
Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
Timepoint [13] 0 0
24 weeks after the end of treatment
Secondary outcome [14] 0 0
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
Timepoint [14] 0 0
24 weeks after the end of treatment
Secondary outcome [15] 0 0
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
Timepoint [15] 0 0
24 weeks after the end of treatment
Secondary outcome [16] 0 0
Percentage of Participants With On-treatment Viral Breakthrough
Timepoint [16] 0 0
within 24 weeks of treatment
Secondary outcome [17] 0 0
Percentage of Participants With Viral Relapse
Timepoint [17] 0 0
within 24 weeks after the end of treatment

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

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
Open (masking not used)
Who is / are masked / blinded?



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
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
340
Recruitment in Australia
Recruitment state(s)
NSW,QLD,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 Center - Greenslopes
Recruitment hospital [5] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [6] 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
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 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
Hawaii
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New Hampshire
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
France
State/province [14] 0 0
Clichy Cedex
Country [15] 0 0
France
State/province [15] 0 0
Creteil
Country [16] 0 0
France
State/province [16] 0 0
Marseille
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
Germany
State/province [18] 0 0
Berlin
Country [19] 0 0
Germany
State/province [19] 0 0
Frankfurt
Country [20] 0 0
Germany
State/province [20] 0 0
Freiburg
Country [21] 0 0
Germany
State/province [21] 0 0
Hannover
Country [22] 0 0
Germany
State/province [22] 0 0
Leipzig
Country [23] 0 0
India
State/province [23] 0 0
Kerala
Country [24] 0 0
India
State/province [24] 0 0
Maharashtra
Country [25] 0 0
India
State/province [25] 0 0
Punjab
Country [26] 0 0
India
State/province [26] 0 0
Uttar Pradesh
Country [27] 0 0
India
State/province [27] 0 0
Guwahati
Country [28] 0 0
India
State/province [28] 0 0
Haryana
Country [29] 0 0
India
State/province [29] 0 0
Hyderabad - Andhra Pradesh
Country [30] 0 0
India
State/province [30] 0 0
Mumbai
Country [31] 0 0
India
State/province [31] 0 0
New Delhi
Country [32] 0 0
Italy
State/province [32] 0 0
Bologna
Country [33] 0 0
Italy
State/province [33] 0 0
Brescia
Country [34] 0 0
Italy
State/province [34] 0 0
Pavia
Country [35] 0 0
Italy
State/province [35] 0 0
Roma
Country [36] 0 0
Italy
State/province [36] 0 0
Torino
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Pusan
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Seoul
Country [39] 0 0
Poland
State/province [39] 0 0
Bialystok
Country [40] 0 0
Poland
State/province [40] 0 0
Lódz
Country [41] 0 0
Poland
State/province [41] 0 0
Warsaw
Country [42] 0 0
Puerto Rico
State/province [42] 0 0
San Juan
Country [43] 0 0
Taiwan
State/province [43] 0 0
Kaohsiung
Country [44] 0 0
Taiwan
State/province [44] 0 0
Niaosong Township
Country [45] 0 0
Taiwan
State/province [45] 0 0
Taichung
Country [46] 0 0
Taiwan
State/province [46] 0 0
Taipei
Country [47] 0 0
Taiwan
State/province [47] 0 0
Yun-Lin
Country [48] 0 0
Thailand
State/province [48] 0 0
Bangkok
Country [49] 0 0
Thailand
State/province [49] 0 0
Chiang Mai
Country [50] 0 0
Thailand
State/province [50] 0 0
Songkla
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Glasgow - Scotland
Country [52] 0 0
United Kingdom
State/province [52] 0 0
London
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Plymouth

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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01215643
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmceuticals
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/ct2/show/NCT01215643