deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT02114151

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis

A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and Cirrhosis

Sponsor: Janssen Infectious Diseases BVBA

Updated 7 times since 2017 Last updated: Mar 7, 2016 Started: Apr 30, 2014 Primary completion: Jan 31, 2015 Completion: Apr 30, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Hepatitis C Virus Infection and is currently completed. Janssen Infectious Diseases BVBA leads this study, which shows 7 recorded versions since 2014 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 8 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Apr 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Janssen Infectious Diseases BVBA
Data source: Janssen Infectious Diseases BVBA

For direct contact, visit the study record on ClinicalTrials.gov .