Hemophilia aPhase 3PRESent-6NCT06568302
The Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial
A Phase 3 study testing SerpinPC in people with Hemophilia a and Hemophilia B, run by ApcinteX Ltd at 2 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia Read more about this study
- Who is it for?
- Ages 12 to 65 years, men only
- Conditions the study is for
- Hemophilia a, Hemophilia B, Hemophilia a with Inhibitor
- What is being tested?
- SerpinPC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 Jul 2024to 29 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Moldova1 site
Institute of Oncology, ARENSIA Exploratory Medicine
Chisinau, MD-2025
About this study
Official title: A Global Open-label Extension Study to Observe the Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial
The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia
- Being tested
- SerpinPC
- Keywords
- Hemophilia, SerpinPC
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerpinPCDrug
Also called Activated Protein C (APC) inhibitor
Administered as SC injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SerpinPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treated bleeds, expressed as annualized bleeding rate (ABR)
Measured: Month 0 to Month 25 or Early termination
Secondary outcomes (4)
Treated spontaneous bleeds (expressed as ABR)
Measured: Month 0 to Month 25 or Early termination
Treated spontaneous joint bleeds (expressed as ABR)
Measured: 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)
Measured: Month 0 to Month 25 or Early termination
Total coagulation factor and/or bypass product consumption
Measured: Month 0 to Month 25 or Early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start11 Jul 2024
- Primary completion29 Jan 2025
- Study completion29 Jan 2025
Why it stopped: Study terminated due to business and strategic decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia aStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- ApcinteX Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centessa Pharmaceuticals plc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568302
- Sponsor's protocol ID
- AP-0106
- Other IDs
- 2023-509965-19, 2023
- Acronym
- PRESent-6
- Status last verified
- Feb 2025
- First submitted
- 21 Aug 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Open-label Extension Study to Observe the Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial
- ClinicalTrials.gov ID
- NCT06568302
- Acronym / sponsor ID
- PRESent-6 / AP-0106
- Keywords
- Hemophilia, SerpinPC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to business and strategic decision.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ApcinteX LtdIndustry (pharma, biotech, devices)
- Collaborators
- Centessa Pharmaceuticals plc
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SerpinPC | Experimental | Drug: SerpinPCParticipants 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. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SerpinPCAlso: Activated Protein C (APC) inhibitorAdministered as SC injection. | Drug | SerpinPC |
Primary outcome
Treated bleeds, expressed as annualized bleeding rate (ABR)
Time frame: Month 0 to Month 25 or Early termination
4 secondary outcomes
Treated spontaneous bleeds (expressed as ABR)
Time frame: Month 0 to Month 25 or Early termination
Treated spontaneous joint bleeds (expressed as ABR)
Time frame: 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)
Time frame: Month 0 to Month 25 or Early termination
Total coagulation factor and/or bypass product consumption
Time frame: Month 0 to Month 25 or Early termination
Results and safety
The study was stopped early (reason given: Study terminated due to business and strategic decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SerpinPC in people with Hemophilia a and Hemophilia B, run by ApcinteX Ltd at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Georgia, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to business and strategic decision.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treated bleeds, expressed as annualized bleeding rate (ABR) (time frame: Month 0 to Month 25 or Early termination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.