deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT02421211

A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection

A Phase 2, 2-panel, Open-label Randomized Study in Hepatitis C Virus Infected Subjects to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir and Ledipasvir in Treatment-naive Participants.

Sponsor: Janssen Sciences Ireland UC

Updated 11 times since 2017 Last updated: Mar 27, 2019 Started: May 19, 2015 Primary completion: Nov 10, 2015 Completion: Jan 27, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Hepatitis C, Chronic, this trial is completed. The trial is conducted by Janssen Sciences Ireland UC and has accumulated 11 data snapshots since 2015. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshotCompleted~Jul 2017 – ~Jun 2018 · 11 months · monthly snapshotCompleted~Jun 2018 – ~Apr 2019 · 10 months · monthly snapshotCompleted~Apr 2019 – ~Jan 2021 · 21 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 9 months · monthly snapshotCompleted

Change History

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

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE2

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE2

Show 6 earlier versions
  1. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE2

  2. Apr 2019 — Jan 2021 [monthly]

    Completed PHASE2

  3. Jun 2018 — Apr 2019 [monthly]

    Completed PHASE2

  4. Jul 2017 — Jun 2018 [monthly]

    Completed PHASE2

  5. Feb 2017 — Jul 2017 [monthly]

    Completed PHASE2

  6. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

May 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Janssen Sciences Ireland UC
Data source: Janssen Sciences Ireland UC

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