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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
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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
State/province [6] 0 0
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
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Belgium
State/province [13] 0 0
Antwerpen
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Belgium
State/province [14] 0 0
Brussels
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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
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France
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Lyon
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France
State/province [22] 0 0
Nice Cedex 03 N/A
Country [23] 0 0
France
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Paris Cedex 12
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
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Germany
State/province [25] 0 0
Frankfurt A. M.
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Germany
State/province [26] 0 0
Hamburg
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Germany
State/province [27] 0 0
Kiel
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Germany
State/province [28] 0 0
Münster
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Germany
State/province [29] 0 0
Ulm
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Germany
State/province [30] 0 0
Würzburg
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Israel
State/province [31] 0 0
Haifa
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Israel
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Zefat
Country [33] 0 0
Mexico
State/province [33] 0 0
Monterrey
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Netherlands
State/province [34] 0 0
Amsterdam
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Netherlands
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Rotterdam
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New Zealand
State/province [36] 0 0
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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Poland
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Czeladz
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Poland
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Kielce
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Poland
State/province [42] 0 0
Myslowice
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Poland
State/province [43] 0 0
Warschau
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Portugal
State/province [44] 0 0
Coimbra
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Portugal
State/province [45] 0 0
Lisboa
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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
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Russian Federation
State/province [53] 0 0
Stavropol
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Spain
State/province [54] 0 0
Barcelona
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Spain
State/province [55] 0 0
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
State/province [58] 0 0
Donetsk
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01323244