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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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) - 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.
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) - SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.
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) - RVR4 was defined as serum HCV RNA < LOQ after 4 weeks of treatment.
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 - EVR was defined as a = 2 log10 decrease in HCV RNA or HCV RNA < LOQ 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 - pEVR was defined as a = 2 log10 decrease in HCV RNA and still detectable (= LOQ) 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 - cEVR was defined as serum HCV RNA < LOQ 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 - eRVR was defined as achieving RVR4 and maintaining HCV RNA < LOQ until Week 12.
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 - ETR was defined as serum HCV RNA < LOQ at treatment end (completed or prematurely discontinued).
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 - 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
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 - 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.
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 - Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.
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 - Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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United States of America
State/province [2] 0 0
Florida
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United States of America
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Illinois
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United States of America
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Indiana
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Louisiana
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Maryland
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Minnesota
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Missouri
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Nebraska
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New Jersey
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New York
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North Carolina
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Texas
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Utah
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Santa Fe
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Gent
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Jud. Iasi
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Bucharest
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Madrid
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Kaohsiung
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Taichung
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Taipei
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Chiang Mai
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Khon Kaen
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Songkla
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United Kingdom
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Birmingham
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Newcastle Upon Tyne
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Hanoi
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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
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)
Trial website
https://clinicaltrials.gov/show/NCT01318694
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
Other publications