Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2010-022867-37
Secondary ID [2] 0 0
CDEB025A2301
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 - 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)
Timepoint [1] 0 0
12 weeks after the end of treatment
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)
Timepoint [1] 0 0
24 weeks after the end of treatment
Secondary outcome [2] 0 0
Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)
Timepoint [2] 0 0
after 4 weeks of treatment
Secondary outcome [3] 0 0
Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment
Timepoint [3] 0 0
after 12 weeks of treatment
Secondary outcome [4] 0 0
Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment
Timepoint [4] 0 0
after 12 weeks of treatment
Secondary outcome [5] 0 0
Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment
Timepoint [5] 0 0
after 12 weeks of treatment
Secondary outcome [6] 0 0
Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment
Timepoint [6] 0 0
from 4 to 12 weeks of treatment
Secondary outcome [7] 0 0
Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks
Timepoint [7] 0 0
at treatment end within 48 weeks
Secondary outcome [8] 0 0
Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks
Timepoint [8] 0 0
within 48 weeks
Secondary outcome [9] 0 0
Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks
Timepoint [9] 0 0
within 48 weeks
Secondary outcome [10] 0 0
Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks
Timepoint [10] 0 0
within 48 weeks
Secondary outcome [11] 0 0
Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks
Timepoint [11] 0 0
within 48 weeks

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

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 3
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
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
1081
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Darlinghurst
Recruitment hospital [2] 0 0
Novartis Investigative Site - Kingswood
Recruitment hospital [3] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [4] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [5] 0 0
Novartis Investigative Site - Greenslopes
Recruitment hospital [6] 0 0
Novartis Investigative Site - Fitzroy
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4120 - Greenslopes
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Argentina
State/province [16] 0 0
Santa Fe
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Cordoba
Country [19] 0 0
Belgium
State/province [19] 0 0
Brussel
Country [20] 0 0
Belgium
State/province [20] 0 0
Bruxelles
Country [21] 0 0
Belgium
State/province [21] 0 0
Gent
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
France
State/province [25] 0 0
Clichy
Country [26] 0 0
France
State/province [26] 0 0
Grenoble
Country [27] 0 0
France
State/province [27] 0 0
Lyon Cedex 04
Country [28] 0 0
France
State/province [28] 0 0
Toulouse cedex 9
Country [29] 0 0
France
State/province [29] 0 0
Villejuif
Country [30] 0 0
Germany
State/province [30] 0 0
Berlin
Country [31] 0 0
Germany
State/province [31] 0 0
Essen
Country [32] 0 0
Germany
State/province [32] 0 0
Frankfurt
Country [33] 0 0
Germany
State/province [33] 0 0
Freiburg
Country [34] 0 0
Germany
State/province [34] 0 0
Hamburg
Country [35] 0 0
Germany
State/province [35] 0 0
Hannover
Country [36] 0 0
Germany
State/province [36] 0 0
Kiel
Country [37] 0 0
Germany
State/province [37] 0 0
Köln
Country [38] 0 0
Germany
State/province [38] 0 0
Leipzig
Country [39] 0 0
Germany
State/province [39] 0 0
Mainz
Country [40] 0 0
Hong Kong
State/province [40] 0 0
Hong Kong
Country [41] 0 0
Hong Kong
State/province [41] 0 0
Hongkong
Country [42] 0 0
Hungary
State/province [42] 0 0
Bekescsaba
Country [43] 0 0
Hungary
State/province [43] 0 0
Budapest
Country [44] 0 0
Hungary
State/province [44] 0 0
Debrecen
Country [45] 0 0
Hungary
State/province [45] 0 0
Kaposvár
Country [46] 0 0
Hungary
State/province [46] 0 0
Pecs
Country [47] 0 0
Hungary
State/province [47] 0 0
Szekesfehervar
Country [48] 0 0
Italy
State/province [48] 0 0
BO
Country [49] 0 0
Italy
State/province [49] 0 0
GE
Country [50] 0 0
Italy
State/province [50] 0 0
MI
Country [51] 0 0
Italy
State/province [51] 0 0
PA
Country [52] 0 0
Italy
State/province [52] 0 0
PD
Country [53] 0 0
Italy
State/province [53] 0 0
PV
Country [54] 0 0
Italy
State/province [54] 0 0
RM
Country [55] 0 0
Italy
State/province [55] 0 0
TO
Country [56] 0 0
Italy
State/province [56] 0 0
Bologna
Country [57] 0 0
Italy
State/province [57] 0 0
Napoli
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Gyeongsangnam-Do
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Korea
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Kyeonggi
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Busan
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Incheon
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Pusan
Country [64] 0 0
Mexico
State/province [64] 0 0
Distrito Federal
Country [65] 0 0
Mexico
State/province [65] 0 0
Nuevo León
Country [66] 0 0
Poland
State/province [66] 0 0
Bialystok
Country [67] 0 0
Poland
State/province [67] 0 0
Bydgoszcz
Country [68] 0 0
Poland
State/province [68] 0 0
Chorzów
Country [69] 0 0
Poland
State/province [69] 0 0
Kielce
Country [70] 0 0
Poland
State/province [70] 0 0
Lódz
Country [71] 0 0
Puerto Rico
State/province [71] 0 0
San Juan
Country [72] 0 0
Romania
State/province [72] 0 0
District 1
Country [73] 0 0
Romania
State/province [73] 0 0
District 3
Country [74] 0 0
Romania
State/province [74] 0 0
Jud. Iasi
Country [75] 0 0
Romania
State/province [75] 0 0
Bucharest
Country [76] 0 0
Romania
State/province [76] 0 0
Cluj Napoca
Country [77] 0 0
Romania
State/province [77] 0 0
Craiova
Country [78] 0 0
Romania
State/province [78] 0 0
Iasi
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Moscow
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Saint-Petersburg
Country [81] 0 0
Russian Federation
State/province [81] 0 0
St.- Petersburg
Country [82] 0 0
Spain
State/province [82] 0 0
Andalucia
Country [83] 0 0
Spain
State/province [83] 0 0
Catalunya
Country [84] 0 0
Spain
State/province [84] 0 0
Comunidad Valenciana
Country [85] 0 0
Spain
State/province [85] 0 0
Madrid
Country [86] 0 0
Taiwan
State/province [86] 0 0
Chia-Yi
Country [87] 0 0
Taiwan
State/province [87] 0 0
Kaohsiung
Country [88] 0 0
Taiwan
State/province [88] 0 0
Niaosong Township
Country [89] 0 0
Taiwan
State/province [89] 0 0
Taichung
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taipei
Country [91] 0 0
Taiwan
State/province [91] 0 0
Yun-Lin
Country [92] 0 0
Thailand
State/province [92] 0 0
Bangkok
Country [93] 0 0
Thailand
State/province [93] 0 0
Chiang Mai
Country [94] 0 0
Thailand
State/province [94] 0 0
Khon Kaen
Country [95] 0 0
Thailand
State/province [95] 0 0
Songkla
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Birmingham
Country [97] 0 0
United Kingdom
State/province [97] 0 0
London
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Newcastle Upon Tyne
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Nottingham
Country [100] 0 0
Vietnam
State/province [100] 0 0
Hanoi
Country [101] 0 0
Vietnam
State/province [101] 0 0
Ho Chi Minh

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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/NCT01318694