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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2012-003535-27
Secondary ID [2] 0 0
1241.36
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 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 - 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SVR12 Rates With Historical Control
Timepoint [1] 0 0
12 Week (post-treatment)
Primary outcome [2] 0 0
Comparisons of SVR12 Rates Across Treatment Arms
Timepoint [2] 0 0
12 Week (post-treatment)
Secondary outcome [1] 0 0
SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.
Timepoint [1] 0 0
4 weeks (after End Of Treatment)
Secondary outcome [2] 0 0
SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.
Timepoint [2] 0 0
4 weeks (after End Of Treatment)
Secondary outcome [3] 0 0
Prognostic Value of SVR12 Predicting SVR24
Timepoint [3] 0 0
24 Week (post-treatment)

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

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?



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
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
Accrual to date
Final
496
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
1241.36.61005 Boehringer Ingelheim Investigational Site - Camperdown
Recruitment hospital [2] 0 0
1241.36.61010 Boehringer Ingelheim Investigational Site - Kogarah
Recruitment hospital [3] 0 0
1241.36.61009 Boehringer Ingelheim Investigational Site - New Lambton
Recruitment hospital [4] 0 0
1241.36.61007 Boehringer Ingelheim Investigational Site - Randwick
Recruitment hospital [5] 0 0
1241.36.61002 Boehringer Ingelheim Investigational Site - Herston
Recruitment hospital [6] 0 0
1241.36.61004 Boehringer Ingelheim Investigational Site - Clayton
Recruitment hospital [7] 0 0
1241.36.61001 Boehringer Ingelheim Investigational Site - Darlinghurst
Recruitment hospital [8] 0 0
1241.36.61008 Boehringer Ingelheim Investigational Site - Heidelberg
Recruitment hospital [9] 0 0
1241.36.61006 Boehringer Ingelheim Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- New Lambton
Recruitment postcode(s) [4] 0 0
- Randwick
Recruitment postcode(s) [5] 0 0
- Herston
Recruitment postcode(s) [6] 0 0
- Clayton
Recruitment postcode(s) [7] 0 0
- Darlinghurst
Recruitment postcode(s) [8] 0 0
- Heidelberg
Recruitment postcode(s) [9] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Mississippi
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
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
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Belgium
State/province [14] 0 0
Antwerpen
Country [15] 0 0
Belgium
State/province [15] 0 0
Bruxelles
Country [16] 0 0
Belgium
State/province [16] 0 0
Edegem
Country [17] 0 0
Belgium
State/province [17] 0 0
Gent
Country [18] 0 0
Belgium
State/province [18] 0 0
Leuven
Country [19] 0 0
Belgium
State/province [19] 0 0
Liège
Country [20] 0 0
Belgium
State/province [20] 0 0
Roeselare
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
British Columbia
Country [23] 0 0
Canada
State/province [23] 0 0
Manitoba
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
France
State/province [25] 0 0
Clichy Cedex
Country [26] 0 0
France
State/province [26] 0 0
Creteil
Country [27] 0 0
France
State/province [27] 0 0
Grenoble Cedex 9
Country [28] 0 0
France
State/province [28] 0 0
Paris Cedex 20
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
France
State/province [30] 0 0
Saint Laurent du Var Cedex
Country [31] 0 0
France
State/province [31] 0 0
Toulouse
Country [32] 0 0
France
State/province [32] 0 0
Villejuif Cedex
Country [33] 0 0
Germany
State/province [33] 0 0
Aachen
Country [34] 0 0
Germany
State/province [34] 0 0
Berlin
Country [35] 0 0
Germany
State/province [35] 0 0
Dortmund
Country [36] 0 0
Germany
State/province [36] 0 0
Düsseldorf
Country [37] 0 0
Germany
State/province [37] 0 0
Erlangen
Country [38] 0 0
Germany
State/province [38] 0 0
Esslingen
Country [39] 0 0
Germany
State/province [39] 0 0
Freiburg
Country [40] 0 0
Germany
State/province [40] 0 0
Hamburg
Country [41] 0 0
Germany
State/province [41] 0 0
Mainz
Country [42] 0 0
Germany
State/province [42] 0 0
Tübingen
Country [43] 0 0
Greece
State/province [43] 0 0
Athens
Country [44] 0 0
Greece
State/province [44] 0 0
Patras
Country [45] 0 0
Greece
State/province [45] 0 0
Rhodes
Country [46] 0 0
Italy
State/province [46] 0 0
Antella (fi)
Country [47] 0 0
Italy
State/province [47] 0 0
Bisceglie (bat)
Country [48] 0 0
Italy
State/province [48] 0 0
Bologna
Country [49] 0 0
Italy
State/province [49] 0 0
Milano
Country [50] 0 0
Italy
State/province [50] 0 0
Palermo
Country [51] 0 0
Italy
State/province [51] 0 0
Pavia
Country [52] 0 0
Italy
State/province [52] 0 0
Pescara
Country [53] 0 0
Italy
State/province [53] 0 0
Roma
Country [54] 0 0
Italy
State/province [54] 0 0
San Giovanni Rotondo (fg)
Country [55] 0 0
New Zealand
State/province [55] 0 0
Auckland NZ
Country [56] 0 0
New Zealand
State/province [56] 0 0
Hamilton
Country [57] 0 0
Portugal
State/province [57] 0 0
Barreiro
Country [58] 0 0
Portugal
State/province [58] 0 0
Coimbra
Country [59] 0 0
Portugal
State/province [59] 0 0
Lisboa
Country [60] 0 0
Spain
State/province [60] 0 0
Badalona (Barcelona)
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
Country [62] 0 0
Spain
State/province [62] 0 0
L'Hospitalet Llobregat (BCN)
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Spain
State/province [64] 0 0
Malaga
Country [65] 0 0
Spain
State/province [65] 0 0
Sevilla
Country [66] 0 0
Spain
State/province [66] 0 0
Vigo (Pontevedra)
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Birmingham
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Edinburgh
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Hull
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Leeds
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Leicester
Country [72] 0 0
United Kingdom
State/province [72] 0 0
London
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Manchester
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Newcastle upon Tyne
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Oxford
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01728324
Trial related presentations / publications
Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naive patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. doi: 10.2147/CEG.S111116. eCollection 2016.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
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/NCT01728324