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Hepatitis CPhase 3NCT03099135

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

A Phase 3 study testing No Treatment in people with Hepatitis C, run by Janssen Research & Development, LLC at 11 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis C
What is being tested?
No Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
11 sitesin 4 countries
Study dates
10 Apr 2017to 13 Feb 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 4 countries.

11 sites in 4 countries

Canada5 sites

  • LAIR Centre

    Vancouver, British Columbia, V5Z 1H2

  • Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia, V5Z 1M9

  • GI Research Institute (G.I.R.I.)

    Vancouver, British Columbia, V6Z 2K5

  • Vancouver ID Research and Care Centre Society

    Vancouver, British Columbia, V6Z2C7

  • PerCuro Clinical Research Ltd.

    Victoria, British Columbia, V8V 3P9

Other trials in Canada

Poland3 sites

  • Wojewodzki Szpital Specjalistyczny im. dr Wl. Bieganskiego

    Lodz, 91-347

  • Hepid Diagnostyka I Terapia Tomasiewicz Kiciak Lekarze Spolka Partnerska

    Lublin, 20 884

  • ID Clinic

    Mysłowice, 41-400

Other trials in Poland

New Zealand2 sites

  • Auckland District Health Board

    Auckland, 1142

  • Christchurch Clinical Studies Trust

    Christchurch, 8011

Other trials in New Zealand

Singapore1 site

  • National University Hospital

    Singapore, 119074

Other trials in Singapore

About this study

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

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.

Read the 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.

Conditions
Hepatitis C
Being tested
No Treatment
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No TreatmentDrug

    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.

Study groups in NCT03099135
Study groupRoleWhat they receive
Odalasvir and AL-335 With or Without SimeprevirOtherParticipants 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.
Receives: Drug: No Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 3 years

Secondary outcomes (2)

  1. 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.

    Measured: Up to 3 years

  2. 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.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2017
  2. Study start10 Apr 2017
  3. Primary completion1 Feb 2018
  4. Study completion13 Feb 2018

Why it stopped: 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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03099135
Sponsor's protocol ID
CR108301
Other IDs
2016-002608-19, 64294178HPC3001, 2016
Status last verified
Jan 2025
First submitted
30 Mar 2017
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing No Treatment in people with Hepatitis C, run by Janssen Research & Development, LLC at 11 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada, Poland, New Zealand, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 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). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Maintaining Sustained Virologic Response (SVR) Until the End of the Long-Term Follow-Up (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03099135.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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