deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT06010953

SS109 and NovoSeven ® PK / PD Profile, and Preliminary Efficacy and Safety of SS109 on Demand Treatment

An Open-label and Multicenter Phase Ib/II Clinical Trial to Evaluate the Safety, Immunogenicity, PK/PD Profile of SS109 and NovoSeven® Following a Single Dose, and the Preliminary Efficacy and Safety of SS109 During On-demand Treatment in Hemophilia Patients With Coagulation Factor VIII or IX Inhibitors

Sponsor: Jiangsu Gensciences lnc.

Interventions SS109
Updated 6 times since 2023 Last updated: Jul 18, 2024 Started: Oct 12, 2023 Primary completion: May 7, 2024 Completion: May 7, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Hemophilia and Hemophilia A With Inhibitor and is currently completed. Jiangsu Gensciences lnc. leads this study, which shows 6 recorded versions since 2023 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Sep 2023 – ~Dec 2023 · 3 months · monthly snapshotNot Yet Recruiting~Dec 2023 – ~Mar 2024 · 3 months · monthly snapshotRecruiting~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshotRecruiting~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Aug 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Status: RecruitingCompleted

  3. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  4. Mar 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  5. Dec 2023 — Mar 2024 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet RecruitingRecruiting

Show 1 earlier version
  1. Sep 2023 — Dec 2023 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Jiangsu Gensciences lnc.
Data source: Jiangsu Gensciences lnc.

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