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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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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 : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: No Treatment Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

Drug Information available for: Simeprevir

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

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


Locations
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Canada, British Columbia
LAIR Centre
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
New Zealand
Auckland District Health Board
Auckland, New Zealand, 1142
Christchurch Clinical Studies Trust
Christchurch, New Zealand, 8011
Poland
Wojewodzki Szpital Specjalistyczny im. dr Wl. Bieganskiego
Lodz, Poland, 91-347
Hepid Diagnostyka I Terapia Tomasiewicz, Kiciak - Lekarze Spółka Partnerska
Lublin, Poland, 20-884
ID Clinic
Mysłowice, Poland, 41-400
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03099135    
Other Study ID Numbers: CR108301
2016-002608-19 ( EudraCT Number )
64294178HPC3001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections