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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01323244




Registration number
NCT01323244
Ethics application status
Date submitted
24/03/2011
Date registered
25/03/2011
Date last updated
4/04/2016

Titles & IDs
Public title
A Study of TMC435 in Combination With Peginterferon Alfa-2A and Ribavirin for Hepatitis C Virus Genotype-1 Infected Patients Who Participated in a Control Group of a TMC435 Study
Scientific title
A Phase III, Open-Label, Single Arm, Rollover Trial of TMC435 in Combination With Peginterferon Alpha-2A and Ribavirin for HCV Genotype-1 Infected Subjects Who Participated in the Placebo Group of a Phase II/III TMC435 Study, or Who Received DAA Treatment in a Tibotec-Sponsored Phase I Study.
Secondary ID [1] 0 0
TMC435-TiDP16-C213
Secondary ID [2] 0 0
CR017983
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 - TMC435

Experimental: TMC435 - TMC435 Type=exact number unit=mg number=150 form=capsule route=oral use once daily for 12 weeks in addition to peginterferon alfa-2a peginterferon and ribavirin for 24 or 48 weeks


Treatment: Drugs: TMC435
Type=exact number, unit=mg, number=150, form=capsule, route=oral use, once daily for 12 weeks in addition to peginterferon alfa-2a peginterferon and ribavirin for 24 or 48 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of participants with sustained viral response
Timepoint [1] 0 0
12 weeks after planned end of treatment
Secondary outcome [1] 0 0
The proportion of participants with sustained viral response
Timepoint [1] 0 0
24 weeks after planned end of treatment
Secondary outcome [2] 0 0
Number of participants with HCV RNA level >1000 IU/mL
Timepoint [2] 0 0
Week 4
Secondary outcome [3] 0 0
Number of participants with viral breakthrough
Timepoint [3] 0 0
Through Week 48
Secondary outcome [4] 0 0
Number of participants with viral relapse
Timepoint [4] 0 0
Through Week 48
Secondary outcome [5] 0 0
Number of participants with normalized alanine aminotransferase levels
Timepoint [5] 0 0
Through Week 48
Secondary outcome [6] 0 0
Number of participants with on-treatment failure
Timepoint [6] 0 0
Through Week 48
Secondary outcome [7] 0 0
Number of participants affected by an adverse event
Timepoint [7] 0 0
Through Week 48

Eligibility
Key inclusion criteria
- Patients who participated in the placebo arm of a TMC435 study who did not achieve
undetectable HCV RNA levels at end of treatment or who relapsed within 1 year after
end of treatment OR Patients who received short-term direct-acting antiviral therapy
in a Tibotec-sponsored study.

- Liver disease stage documented by liver biopsy is required within 3 years prior to
screening unless contraindicated.
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Infection with human immunodeficiency virus.

- Liver disease not related to hepatitic C infection.

- Significant laboratory abnormalities or other active diseases.

- Pregnant or planning to become pregnant.

- Prematurely stopped medication in previous TMC435 study for non-compliance or for
safety reasons.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Concord
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Wentworthville
Recruitment hospital [5] 0 0
- Woolloongabba N/A
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Wentworthville
Recruitment postcode(s) [5] 0 0
- Woolloongabba N/A
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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
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United States of America
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Louisiana
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United States of America
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Mississippi
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United States of America
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North Carolina
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United States of America
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Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Rosario, Santa Fe
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Belgium
State/province [13] 0 0
Antwerpen
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussels
Country [15] 0 0
Belgium
State/province [15] 0 0
Gent
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Sofia
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
France
State/province [20] 0 0
Grenoble
Country [21] 0 0
France
State/province [21] 0 0
Lyon
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France
State/province [22] 0 0
Nice Cedex 03 N/A
Country [23] 0 0
France
State/province [23] 0 0
Paris Cedex 12
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Frankfurt A. M.
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Germany
State/province [26] 0 0
Hamburg
Country [27] 0 0
Germany
State/province [27] 0 0
Kiel
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Germany
State/province [28] 0 0
Münster
Country [29] 0 0
Germany
State/province [29] 0 0
Ulm
Country [30] 0 0
Germany
State/province [30] 0 0
Würzburg
Country [31] 0 0
Israel
State/province [31] 0 0
Haifa
Country [32] 0 0
Israel
State/province [32] 0 0
Zefat
Country [33] 0 0
Mexico
State/province [33] 0 0
Monterrey
Country [34] 0 0
Netherlands
State/province [34] 0 0
Amsterdam
Country [35] 0 0
Netherlands
State/province [35] 0 0
Rotterdam
Country [36] 0 0
New Zealand
State/province [36] 0 0
Auckland
Country [37] 0 0
New Zealand
State/province [37] 0 0
Christchurch
Country [38] 0 0
Poland
State/province [38] 0 0
Bydgoszcz
Country [39] 0 0
Poland
State/province [39] 0 0
Chorzów
Country [40] 0 0
Poland
State/province [40] 0 0
Czeladz
Country [41] 0 0
Poland
State/province [41] 0 0
Kielce
Country [42] 0 0
Poland
State/province [42] 0 0
Myslowice
Country [43] 0 0
Poland
State/province [43] 0 0
Warschau
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Portugal
State/province [44] 0 0
Coimbra
Country [45] 0 0
Portugal
State/province [45] 0 0
Lisboa
Country [46] 0 0
Puerto Rico
State/province [46] 0 0
San Juan
Country [47] 0 0
Romania
State/province [47] 0 0
Bucuresti
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Moscow
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Saint-Petersburg
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Samara
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Smolensk
Country [52] 0 0
Russian Federation
State/province [52] 0 0
St Petersburg
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Stavropol
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Sevilla N/A
Country [57] 0 0
Spain
State/province [57] 0 0
Valencia
Country [58] 0 0
Ukraine
State/province [58] 0 0
Donetsk
Country [59] 0 0
Ukraine
State/province [59] 0 0
Kyiv
Country [60] 0 0
Ukraine
State/province [60] 0 0
Vinnitsa
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Birmingham
Country [62] 0 0
United Kingdom
State/province [62] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen R&D Ireland
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to investigate the efficacy of a treatment with TMC435 in
combination with peginterferon alfa-2a and ribavirin in patients who did not clear their
hepatitis C infection with peginterferon alfa-2a and ribavirin alone within a previous trial
conducted by Tibotec, or who participated in Tibotec trials in which antivirals directed
against hepatitis C virus (HCV) were evaluated for short periods of time.
Trial website
https://clinicaltrials.gov/show/NCT01323244
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen R&D Ireland Clinical Trial
Address 0 0
Janssen R&D Ireland
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