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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
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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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01318694