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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03099135




Registration number
NCT03099135
Ethics application status
Date submitted
30/03/2017
Date registered
4/04/2017
Date last updated
30/04/2019

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
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
Secondary ID [1] 0 0
2016-002608-19
Secondary ID [2] 0 0
CR108301
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 - 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Maintaining Sustained Virologic Response (SVR) Until the End of the Long-Term Follow-Up - Participants maintained SVR if HCV RNA less than (<) lower limit of quantification (LLOQ) (Detected or Not Detected) per timepoint in this study.
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Percentage of Participants With Late Viral Relapse Among Participants who Achieved SVR at Last Post-Therapy Visit of Parent Study (LPVPS) - 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.
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Liver Disease Status in All Participants who Achieved or did not Achieve SVR at LPVPS - 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.
Timepoint [2] 0 0
Up to 3 years

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
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Other
Allocation to intervention
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch
Country [4] 0 0
Poland
State/province [4] 0 0
Lodz
Country [5] 0 0
Poland
State/province [5] 0 0
Lublin
Country [6] 0 0
Poland
State/province [6] 0 0
Myslowice
Country [7] 0 0
Singapore
State/province [7] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03099135
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
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/show/NCT03099135