deltatrials
Completed PHASE3 INTERVENTIONAL 4-arm NCT03315455

Efficacy, Safety, and Pharmacokinetic Study of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Participants (HAVEN 5)

A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Patients

Sponsor: Hoffmann-La Roche

Conditions Hemophilia A
Interventions Emicizumab
Updated 45 times since 2017 Last updated: Sep 3, 2025 Started: Apr 26, 2018 Primary completion: Aug 3, 2022 Completion: Aug 29, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03315455, this PHASE3 trial focuses on Hemophilia A and remains completed. Sponsored by Hoffmann-La Roche, it has been updated 45 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Nov 2017 – ~Dec 2017 · 30 days · monthly snapshot~Dec 2017 – ~Jan 2018 · 31 days · monthly snapshot~Jan 2018 – ~Feb 2018 · 31 days · monthly snapshot~Feb 2018 – ~Apr 2018 · 59 days · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Nov 2018 · 2 months · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~Jul 2019 · 3 months · monthly snapshot~Jul 2019 – ~Oct 2019 · 3 months · monthly snapshot~Oct 2019 – ~Jan 2020 · 3 months · monthly snapshot~Jan 2020 – ~Apr 2020 · 3 months · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Aug 2020 · 3 months · monthly snapshot~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Mar 2022 · 3 months · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~Jul 2022 · 3 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshot~Dec 2022 – ~Mar 2023 · 3 months · monthly snapshot~Mar 2023 – ~Apr 2024 · 13 months · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Feb 2025 · 4 months · monthly snapshot~Feb 2025 – ~May 2025 · 3 months · monthly snapshot~May 2025 – ~Jul 2025 · 2 months · monthly snapshot~Jul 2025 – ~Aug 2025 · 31 days · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – present · 11 months · monthly snapshot

Change History

45 versions recorded

  1. Oct 2025 — Present [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  2. Sep 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE3

  3. Aug 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Jul 2025 — Aug 2025 [monthly]

    Active Not Recruiting PHASE3

  5. May 2025 — Jul 2025 [monthly]

    Active Not Recruiting PHASE3

▶ Show 40 earlier versions

  1. Feb 2025 — May 2025 [monthly]

    Active Not Recruiting PHASE3

  2. Oct 2024 — Feb 2025 [monthly]

    Active Not Recruiting PHASE3

  3. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  5. May 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  6. Apr 2024 — May 2024 [monthly]

    Active Not Recruiting PHASE3

  7. Mar 2023 — Apr 2024 [monthly]

    Active Not Recruiting PHASE3

  8. Dec 2022 — Mar 2023 [monthly]

    Active Not Recruiting PHASE3

  9. Sep 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE3

  10. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  11. Apr 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE3

  12. Mar 2022 — Apr 2022 [monthly]

    Active Not Recruiting PHASE3

  13. Dec 2021 — Mar 2022 [monthly]

    Active Not Recruiting PHASE3

  14. Sep 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  15. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

    Status: Active Not Recruiting → Recruiting

  16. May 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  17. Jan 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE3

  18. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  19. Aug 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

  20. May 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: Enrolling By Invitation → Active Not Recruiting

  21. Apr 2020 — May 2020 [monthly]

    Enrolling By Invitation PHASE3

  22. Jan 2020 — Apr 2020 [monthly]

    Enrolling By Invitation PHASE3

  23. Oct 2019 — Jan 2020 [monthly]

    Enrolling By Invitation PHASE3

    Status: Active Not Recruiting → Enrolling By Invitation

  24. Jul 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE3

  25. Apr 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  26. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  27. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

  28. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE3

  29. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

  30. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

  31. Sep 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

  32. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE3

  33. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE3

  34. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE3

  35. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  36. Apr 2018 — May 2018 [monthly]

    Not Yet Recruiting PHASE3

  37. Feb 2018 — Apr 2018 [monthly]

    Not Yet Recruiting PHASE3

  38. Jan 2018 — Feb 2018 [monthly]

    Not Yet Recruiting PHASE3

  39. Dec 2017 — Jan 2018 [monthly]

    Not Yet Recruiting PHASE3

  40. Nov 2017 — Dec 2017 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hoffmann-La Roche
Data source: Hoffmann-La Roche

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

Study Locations

Bangkok, Thailand , Beijing, China , Changsha, China , George Town, Malaysia , Guangdong Province Guangzhou City, China , Hong Kong, Hong Kong , Sabah, Malaysia , Shanghai, China , Shatin, Hong Kong , Tianjin, China and 1 more location