deltatrials
Completed PHASE2 INTERVENTIONAL 5-arm NCT00996476

A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients (DRAGON)

A Phase II, Randomized, Open-label Study in Japan to Investigate the Efficacy, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Treatment naïve, Genotype 1, Chronic Hepatitis C Subjects

Sponsor: Janssen Pharmaceutical K.K.

Updated 8 times since 2017 Last updated: Mar 21, 2014 Started: Jul 31, 2009 Primary completion: Jan 31, 2011 Completion: Jan 31, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00996476, this PHASE2 trial focuses on Hepatitis C, Chronic and remains completed. Sponsored by Janssen Pharmaceutical K.K., it has been updated 8 times since 2009, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

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 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 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

8 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. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE2

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Jul 2009

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Janssen Pharmaceutical K.K.
Data source: Janssen Pharmaceutical K.K.

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