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TerminatedNCT06568302PRESent-6Updated Feb 10, 2025

The Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial

A Phase 3 interventional study of SerpinPC in Hemophilia a, Hemophilia B and Hemophilia a with Inhibitor, sponsored by ApcinteX Ltd. Terminated at 2 sites in 2 countries. Open to male participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by ApcinteX Ltd · Phase 3, Interventional, and Treatment

Why this study was terminated
Study terminated due to business and strategic decision.

From the registry’s dates

  • Primary completion was Jan 2025, 1 year 8 months ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
12 Years to 65 Years
Sex
Male
01

Study summary

The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia

02

Conditions studied

  • Hemophilia a
  • Hemophilia B
  • Hemophilia a with Inhibitor
  • Hemophilia B with Inhibitor

Keywords

  • Hemophilia
  • SerpinPC
03

In context

Hemophilia A

866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.

This study's enrollment of 15 is below the median of 28 across 512 interventional studies indexed under Hemophilia A.

Browse Hemophilia A studies →

Lead sponsor

ApcinteX Ltd is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Male participants greater than or equal to (>=) 12 and less than or equal to (\<=) 65 years of age at the time of informed consent
  • Completed participation in a sponsored SerpinPC hemophilia clinical trial and, in the opinion of the investigator, was compliant with the study including compliance with diary entries.
  • Capable of providing written informed consent (adolescent assent and parent/guardian consent when appropriate) for participation

Exclusion criteria

Exclusion Criteria:

  • Previous deep vein thrombosis and pulmonary embolism, myocardial infarction, or embolic stroke
  • Participation in another interventional clinical trial, except for SerpinPC trials
  • Any other significant conditions or comorbidities that, in the opinion of the investigator, would make the subject unsuitable for enrolment or could interfere with participation in or completion of the study
  • Treatment with anticoagulant or antiplatelet drugs
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    SerpinPC

    Participants will receive SerpinPC 1.2 milligrams/kilograms (mg/kg) subcutaneous injection every 2 weeks (Q2W) once they have completed treatment in a SerpinPC parent study.

    Drug: SerpinPC

Interventions

  • DrugSerpinPC

    Administered as SC injection.

    Also known as: Activated Protein C (APC) inhibitor

06

What researchers measure

Primary outcomes

  1. Treated bleeds, expressed as annualized bleeding rate (ABR)

    Time frame: Month 0 to Month 25 or Early termination

Secondary outcomes

  1. Treated spontaneous bleeds (expressed as ABR)

    Time frame: Month 0 to Month 25 or Early termination

  2. Treated spontaneous joint bleeds (expressed as ABR)

    Time frame: Month 0 to Month 25 or Early termination

  3. All bleeds requiring treatment (expressed as ABR, ie, all treated bleeds and all bleeds that would ordinarily be treated with factor concentrate/bypass agent if therapy were available)

    Time frame: Month 0 to Month 25 or Early termination

  4. Total coagulation factor and/or bypass product consumption

    Time frame: Month 0 to Month 25 or Early termination

07

Study locations

2 sites
  • ARENSIA Exploratory Medicine LLC
    Tbilisi, 0112, Georgia
  • Institute of Oncology, ARENSIA Exploratory Medicine
    Chisinau, MD-2025, Moldova, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06568302
Lead sponsor
ApcinteX Ltd
Collaborators
Centessa Pharmaceuticals plc
Responsible party
Sponsor
First posted
Aug 23, 2024
Start date
Jul 11, 2024
Primary completion
Jan 29, 2025
Completion
Jan 29, 2025
Last update
Feb 10, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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