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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03099135|
Recruitment Status : Terminated (Recruitment prematurely stopped based on decision to stop HPC program (not due to safety or efficacy results) + On 31 Jan 2018 decision to stop the study)
First Posted : April 4, 2017
Last Update Posted : April 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: No Treatment||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||April 10, 2017|
|Actual Primary Completion Date :||February 1, 2018|
|Actual Study Completion Date :||February 13, 2018|
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.
Drug: 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.
- Percentage of Participants Maintaining Sustained Virologic Response (SVR) Until the End of the Long-Term Follow-Up [ Time Frame: Up to 3 years ]Participants maintained SVR if HCV RNA less than (<) lower limit of quantification (LLOQ) (Detected or Not Detected) per timepoint in this study.
- Percentage of Participants With Late Viral Relapse Among Participants who Achieved SVR at Last Post-Therapy Visit of Parent Study (LPVPS) [ Time Frame: Up to 3 years ]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.
- Liver Disease Status in All Participants who Achieved or did not Achieve SVR at LPVPS [ Time Frame: Up to 3 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099135
|Canada, British Columbia|
|Vancouver, British Columbia, Canada, V5Z 1H2|
|Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|GI Research Institute (G.I.R.I.)|
|Vancouver, British Columbia, Canada, V6Z 2K5|
|Vancouver ID Research and Care Centre Society|
|Vancouver, British Columbia, Canada, V6Z2C7|
|PerCuro Clinical Research Ltd.|
|Victoria, British Columbia, Canada, V8V 3P9|
|Auckland District Health Board|
|Auckland, New Zealand, 1142|
|Christchurch Clinical Studies Trust|
|Christchurch, New Zealand, 8011|
|Wojewodzki Szpital Specjalistyczny im. dr Wl. Bieganskiego|
|Lodz, Poland, 91-347|
|Hepid Diagnostyka I Terapia Tomasiewicz, Kiciak - Lekarze Spółka Partnerska|
|Lublin, Poland, 20-884|
|Mysłowice, Poland, 41-400|
|National University Hospital|
|Singapore, Singapore, 119074|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|