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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/NCT01728324
Registration number
NCT01728324
Ethics application status
Date submitted
2/11/2012
Date registered
19/11/2012
Date last updated
12/02/2016
Titles & IDs
Public title
Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
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Scientific title
A Phase III Randomised, Partially Double-blind and Placebo-controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Chronic Genotype 1 Hepatitis C Infection in an Extended Population of Treatment naïve Patients That Includes Those Ineligible to Receive Peginterferon
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Secondary ID [1]
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2012-003535-27
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Secondary ID [2]
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1241.36
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BI 207127-placebo: 8-week treatment
Treatment: Drugs - Ribavirin: 24-week treatment
Treatment: Drugs - BI 207127: 24-week treatment
Treatment: Drugs - Faldaprevir: 24-week treatment
Treatment: Drugs - Faldaprevir: 24-week treatment
Treatment: Drugs - Ribavirin-placebo: 8-week treatment
Treatment: Drugs - BI 207127: 24-week treatment
Treatment: Drugs - Faldaprevir-placebo: 8-week treatment
Treatment: Drugs - Faldaprevir: 16-week treatment
Treatment: Drugs - Ribavirin: 16-week treatment
Treatment: Drugs - RBV: 24-week treatment
Treatment: Drugs - BI 207127: 16-week treatment
Experimental: Randomised 24-week arm - BI 207127 in combination with FDV and RBV for 24 weeks (randomised)
Experimental: Randomised 16-week arm - BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)
Experimental: Allocated 24-week arm - BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)
Treatment: Drugs: BI 207127-placebo: 8-week treatment
8 weeks of placebo treatment
Treatment: Drugs: Ribavirin: 24-week treatment
24 weeks of active treatment
Treatment: Drugs: BI 207127: 24-week treatment
24 weeks of active treatment
Treatment: Drugs: Faldaprevir: 24-week treatment
24 weeks of active treatment
Treatment: Drugs: Faldaprevir: 24-week treatment
24 weeks of active treatment
Treatment: Drugs: Ribavirin-placebo: 8-week treatment
8 weeks of placebo treatment
Treatment: Drugs: BI 207127: 24-week treatment
24 weeks of active treatment
Treatment: Drugs: Faldaprevir-placebo: 8-week treatment
8 weeks of placebo treatment
Treatment: Drugs: Faldaprevir: 16-week treatment
16 weeks of active treatment
Treatment: Drugs: Ribavirin: 16-week treatment
16 weeks of active treatment
Treatment: Drugs: RBV: 24-week treatment
24 weeks of active treatment
Treatment: Drugs: BI 207127: 16-week treatment
16 weeks of active treatment
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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SVR12 Rates With Historical Control
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Assessment method [1]
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Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint.
The number of participants analyzed are actually adjusted number of participant analyzed.
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Timepoint [1]
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12 Week (post-treatment)
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Primary outcome [2]
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Comparisons of SVR12 Rates Across Treatment Arms
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Assessment method [2]
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Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.
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Timepoint [2]
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12 Week (post-treatment)
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Secondary outcome [1]
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SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.
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Assessment method [1]
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Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT.
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Timepoint [1]
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4 weeks (after End Of Treatment)
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Secondary outcome [2]
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SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.
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Assessment method [2]
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Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT.
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Timepoint [2]
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4 weeks (after End Of Treatment)
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Secondary outcome [3]
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Prognostic Value of SVR12 Predicting SVR24
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Assessment method [3]
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The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.
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Timepoint [3]
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24 Week (post-treatment)
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected
HCV RNA at screening
2. HCV infection of sub-GT1b confirmed by genotypic testing at screening.
3. HCV viral load =1,000 IU/mL at randomisation.
4. Patients who have never been previously treated with any other HCV treatment regimen.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
1. HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at
screening.
2. HCV infection of sub-GT1a, mixed GT1a/1b, or undefined GT1.
3. Liver disease due to causes other than chronic HCV infection.
4. HIV infection.
5. Hepatitis B virus infection based on presence of HBs-Ag.
6. Confirmed or suspected active malignancy or history of malignancy within the last 5
years prior to screening.
7. History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12
months prior to randomisation.
8. Subject is not willing to comply with the precautionary measures to prevent
photosensitivity (avoid excessive sun exposure and use sun block on a daily basis).
9. Decompensated liver disease, or history of decompensated liver disease.
10. Clinical evidence of unstable cardiovascular disease which may further decompensate
due to anemia.
11. Red blood cell disorders.
12. Body weight <40 kg or >125 kg.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2015
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Sample size
Target
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Accrual to date
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Final
496
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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1241.36.61005 Boehringer Ingelheim Investigational Site - Camperdown
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Recruitment hospital [2]
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1241.36.61010 Boehringer Ingelheim Investigational Site - Kogarah
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Recruitment hospital [3]
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1241.36.61009 Boehringer Ingelheim Investigational Site - New Lambton
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Recruitment hospital [4]
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1241.36.61007 Boehringer Ingelheim Investigational Site - Randwick
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Recruitment hospital [5]
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1241.36.61002 Boehringer Ingelheim Investigational Site - Herston
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Recruitment hospital [6]
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1241.36.61004 Boehringer Ingelheim Investigational Site - Clayton
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Recruitment hospital [7]
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1241.36.61001 Boehringer Ingelheim Investigational Site - Darlinghurst
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Recruitment hospital [8]
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1241.36.61008 Boehringer Ingelheim Investigational Site - Heidelberg
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Recruitment hospital [9]
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1241.36.61006 Boehringer Ingelheim Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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- Camperdown
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Recruitment postcode(s) [2]
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- Kogarah
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- New Lambton
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- Randwick
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- Herston
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- Clayton
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- Darlinghurst
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- Heidelberg
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Recruitment postcode(s) [9]
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- Melbourne
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Recruitment outside Australia
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United States of America
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Oxford
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Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI
207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically
infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01728324
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Boehringer Ingelheim
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Address
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Boehringer Ingelheim
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01728324
Download to PDF