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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
Not applicable
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
State/province [18] 0 0
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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Poland
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Czeladz
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Poland
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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
State/province [60] 0 0
Vinnitsa
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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/study/NCT01323244
Trial related presentations / publications
Gane EJ, DeJesus E, Janczewska E, George J, Diago M, Da Silva MH, Reesink H, Nikitin I, Hinrichsen H, Bourgeois S, Ferenci P, Shukla U, Kalmeijer R, Lenz O, Fevery B, Corbett C, Beumont M, Jessner W. Simeprevir with peginterferon alpha-2a/ribavirin for chronic hepatitis C virus genotype 1 infection in treatment-experienced patients: an open-label, rollover study. BMC Infect Dis. 2017 Jun 2;17(1):389. doi: 10.1186/s12879-017-2444-3.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01323244