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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01349465 |
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Date of registration:
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26/04/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection
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Scientific title:
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A Prospective 3-Year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study With a TMC435-Containing Regimen for the Treatment of Hepatitis C Virus (HCV) Infection |
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Date of first enrolment:
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July 4, 2011 |
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Target sample size:
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249 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01349465 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Canada
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France
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Germany
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Poland
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Russian Federation
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United States
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Contacts
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Name:
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Janssen R&D Ireland Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen R&D Ireland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have previously participated in a Phase IIb or Phase III study
- Must have received at least one dose of TMC435 in that study
- Has completed the last post-therapy follow-up visit of the previous (LPVPS) study
Exclusion Criteria:
- Must be currently enrolled or plan to enroll in another study with an investigational
drug or invasive investigational medical device
- Have received antiviral or immunomodulating treatment, including therapeutic vaccines,
for hepatitis C virus (HCV) between LPVPS and the screening visit of present study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hepatitis C
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Intervention(s)
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Drug: No treatment
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Primary Outcome(s)
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Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study
[Time Frame: Baseline and Month 36]
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Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study
[Time Frame: Baseline and Month 36]
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Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study
[Time Frame: Baseline and Month 36]
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Percentage of Participants Maintaining SVR at the Last Available Visit
[Time Frame: Last Available Visit (Month 36 for subjects completing the study)]
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Secondary Outcome(s)
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Percentage of Participants With Late Viral Relapse
[Time Frame: End of study (at month 36)]
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Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
[Time Frame: End of study (at month 36)]
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Secondary ID(s)
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CR017365
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TMC435HPC3002
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2010-019843-20
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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