NCT06568302

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2024

Shorter than P25 for phase_3

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 21, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2025

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

August 21, 2024

Last Update Submit

February 6, 2025

Conditions

Hemophilia aHemophilia BHemophilia a with InhibitorHemophilia B with Inhibitor

Keywords

HemophiliaSerpinPC

Outcome Measures

Primary Outcomes (1)

  • Treated bleeds, expressed as annualized bleeding rate (ABR)

    Month 0 to Month 25 or Early termination

Secondary Outcomes (4)

  • Treated spontaneous bleeds (expressed as ABR)

    Month 0 to Month 25 or Early termination

  • Treated spontaneous joint bleeds (expressed as ABR)

    Month 0 to Month 25 or Early termination

  • 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)

    Month 0 to Month 25 or Early termination

  • Total coagulation factor and/or bypass product consumption

    Month 0 to Month 25 or Early termination

Study Arms (1)

SerpinPC

EXPERIMENTAL

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

SerpinPCDRUG

Administered as SC injection.

Also known as: Activated Protein C (APC) inhibitor
SerpinPC

Eligibility Criteria

Age12 Years - 65 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ARENSIA Exploratory Medicine LLC

Tbilisi, 0112, Georgia

Location

Institute of Oncology, ARENSIA Exploratory Medicine

Chisinau, MD-2025, Moldova

Location

MeSH Terms

Conditions

Hemophilia AHemophilia B

Interventions

Protein C

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesGlycoproteinsGlycoconjugatesCarbohydratesBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBlood Coagulation Factor InhibitorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2024

First Posted

August 23, 2024

Study Start

July 11, 2024

Primary Completion

January 29, 2025

Study Completion

January 29, 2025

Last Updated

February 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

GE(1)MO(1)