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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/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
Sex
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
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
142
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
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United States of America
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Colorado
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Florida
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United States of America
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Louisiana
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Mississippi
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North Carolina
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Texas
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Argentina
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Buenos Aires
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Argentina
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Rosario, Santa Fe
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Austria
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Wien
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Gent
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Brazil
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Sao Paulo
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Bulgaria
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Sofia
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Canada
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Ontario
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Canada
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Quebec
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France
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Grenoble
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France
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Lyon
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France
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Nice Cedex 03 N/A
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France
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Paris Cedex 12
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Germany
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Berlin
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Germany
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Frankfurt A. M.
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Germany
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Hamburg
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Germany
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Kiel
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Germany
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Münster
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Germany
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Ulm
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Germany
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Würzburg
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Israel
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Haifa
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Israel
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Zefat
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Mexico
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Monterrey
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Netherlands
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Amsterdam
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Netherlands
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Rotterdam
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Poland
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Bydgoszcz
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Poland
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Chorzów
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Czeladz
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Kielce
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Poland
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Myslowice
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Poland
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Warschau
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Portugal
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Coimbra
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Portugal
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Lisboa
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Puerto Rico
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San Juan
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Romania
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Bucuresti
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Samara
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Russian Federation
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Smolensk
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Russian Federation
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St Petersburg
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Russian Federation
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Stavropol
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla N/A
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Spain
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Valencia
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Ukraine
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Donetsk
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Ukraine
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Kyiv
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Ukraine
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Vinnitsa
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United Kingdom
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Birmingham
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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/ct2/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