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.
This multicentre study will not provide any study treatment but collect follow-up data for up to 3 years to assess the long term durability of SVR achieved in one of the parent studies \[phase 2 or 3 with AL-335 and Odalasvir (ODV) with or without Simeprevir (SMV\]. In addition participants who failed to achieve an SVR in the parent study can be enrolled to assess the presence of resistance associated substitutions (RAS) and their persistance over time. It is expected that the vast majority of approximately 250 participants will enrolled in the study. Safety parameters and Liver disease status will be assessed in all participants over time.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
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.
LAIR Centre
Vancouver, British Columbia, Canada
Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
GI Research Institute (G.I.R.I.)
Vancouver, British Columbia, Canada
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.
Time frame: Up to 3 years
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.
Time frame: Up to 3 years
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.
Time frame: Up to 3 years
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Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, Canada
PerCuro Clinical Research Ltd.
Victoria, British Columbia, Canada
Auckland District Health Board
Auckland, New Zealand
Christchurch Clinical Studies Trust
Christchurch, New Zealand
Wojewodzki Szpital Specjalistyczny im. dr Wl. Bieganskiego
Lodz, Poland
Hepid Diagnostyka I Terapia Tomasiewicz Kiciak Lekarze Spolka Partnerska
Lublin, Poland
ID Clinic
Mysłowice, Poland
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