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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/NCT03099135
Registration number
NCT03099135
Ethics application status
Date submitted
30/03/2017
Date registered
4/04/2017
Date last updated
13/05/2020
Titles & IDs
Public title
A Long Term Follow-up Study in Participants Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection
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Scientific title
A Prospective 3-Year Follow-up Study in Subjects Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection
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Secondary ID [1]
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2016-002608-19
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Secondary ID [2]
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CR108301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - No Treatment
Other: Odalasvir and AL-335 With or Without Simeprevir - Participants who completed the LPVPS (Phase 2 or Phase 3 study), in which they received a regimen containing Odalasvir and AL-335 With or Without Simeprevir for the treatment of HCV infection, and who agree to participate in this follow-up study will be assessed for durability of SVR, incidence of late viral relapse, presence and long term-persistence of resistance associated substitutions (RAS) and liver disease status.
Treatment: Drugs: No Treatment
No treatment will be given tp participants during this follow-up study of previous phase II and Phase III in which they have received Odalavir and AL-335 with or without Simeprevir.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Maintaining Sustained Virologic Response (SVR) Until the End of the Long-Term Follow-Up
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Assessment method [1]
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Participants maintained SVR if HCV RNA less than (<) lower limit of quantification (LLOQ) (Detected or Not Detected) per timepoint in this study.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [1]
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Percentage of Participants With Late Viral Relapse Among Participants who Achieved SVR at Last Post-Therapy Visit of Parent Study (LPVPS)
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Assessment method [1]
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Late viral relapse is defined as: participants who achieved SVR at LPVPS but have confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up in this study. SVR at LPVPS is defined as participants who achieved SVR12 in the parent study, and maintained HCV RNA<LLOQ until LPVPS.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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Liver Disease Status in All Participants who Achieved or did not Achieve SVR at LPVPS
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Assessment method [2]
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Liver disease status will be evaluated using child pugh assessment score and laboratory tests including aspartate amino transferase to Platelet Ratio Index (APRI) and Metavir. Child Pugh score includes 5 clinical measures: 1) Encephalopathy grade, 2) Ascites, 3) Serum bilirubin, 4) Serum albumin, 5) Prothrombin time for assessing status of liver disease. Each measure is scored 1 to 3, with 3 indicating most severe derangement. The individual item scores will be summed to yield total score ranging from 5 to 15. Child-Pugh A (mild): 5-6 points, Child-Pugh B (moderate): 7-9 points, and Child-Pugh C (severe): 10-15 points.
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Timepoint [2]
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Up to 3 years
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Eligibility
Key inclusion criteria
- Participant was randomized to a regimen containing Odalasvir (ODV) with AL-335 with or
without Simeprevir in a preceding Phase 2 or Phase 3 study (parent study)
- Participant received at least 1 dose of ODV with AL-335 with or without SMV in the
parent study
- Participant has completed the last post-therapy follow-up visit of the parent study (
LPVPS) and has not passed the screening period of 6 + 3 months after the LPVPS
- Participant has signed an informed consent form (ICF) indicating that he or she
understands the purpose of and procedures required for the study and is willing to
participate in the study
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participant is currently enrolled or plans to enroll in another study with an
investigational drug (including investigational vaccines) or an invasive
investigational medical device between the LPVPS and Visit 6 of the present study (36
months (+/-) 4 weeks after the LPVPS of the parent study)
- Participant received antiviral or immunomodulating treatment, including therapeutic
vaccines, for HCV infection between the LPVPS and the screening visit of the present
study, or is planned to receive such treatment during the period of this follow-up
study
- Participant is not able to adhere to the requirements of the follow-up study
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Study design
Purpose of the study
Other
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/04/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/02/2018
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Sample size
Target
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Canada
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State/province [1]
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British Columbia
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Country [2]
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New Zealand
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State/province [2]
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Auckland
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Country [3]
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New Zealand
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State/province [3]
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Christchurch
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Poland
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State/province [4]
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Lodz
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Country [5]
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Poland
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Lublin
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Poland
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State/province [6]
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Myslowice
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Country [7]
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Singapore
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State/province [7]
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Singapore
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The main purpose of this study is to evaluate the durability of Sustained virologic response
(SVR) in participants who achieved SVR at last post-therapy visit of parent studies (LPVPS)
with NCT Numbers NCT02569710 and NCT02765490.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03099135
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03099135
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