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Coagulation Factor Replacement Therapy

SerpinPC for Severe Hemophilia (PRESent-2 Trial)

Phase 2
Recruiting
Research Sponsored by ApcinteX Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 24 weeks
Awards & highlights

Summary

This trial tests a new injection called SerpinPC to prevent bleeding in people with severe hemophilia A or B. It aims to see if SerpinPC is safe and effective, especially for those who don't respond well to other treatments. SerpinPC works by helping the blood clot better. Serpins are being explored as potential treatments for hemophilia by rebalancing coagulation.

Who is the study for?
This trial is for males aged 12-65 with severe Hemophilia A or moderately severe to severe Hemophilia B, without inhibitors. Participants must have a history of bleeding episodes and be on or willing to commit to a prophylaxis program. Adolescents can join after safety assessments in adults.
What is being tested?
The study tests SerpinPC's effectiveness and safety when given subcutaneously as a preventive treatment for hemophilia. It has three phases: dose justification, confirmation, and an extension phase for ongoing evaluation.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions related to SerpinPC administration which could include typical drug-related responses such as injection site reactions, allergies, or other systemic effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Haemophilia-specific QoL Instrument for Adults (Haem-A-QoL) Physical Health scale in participants aged 17 to ≤65 years with hemophilia

Side effects data

From 2010 Phase 3 trial • 216 Patients • NCT00708435
7%
Constipation
6%
Oedema peripheral
6%
Hypokalaemia
4%
Diarrhoea
4%
Cardiac failure congestive
4%
Pyrexia
4%
Headache
4%
Pulmonary oedema
3%
Hypomagnesaemia
3%
Insomnia
3%
Nausea
3%
Dyspnoea
3%
Chest pain
3%
Hyperkalaemia
3%
Fluid overload
3%
Urinary tract infection
3%
Hypotension
3%
Rash
2%
Anxiety
2%
Anaemia
2%
Vomiting
2%
Myocardial ischaemia
2%
Encephalopathy
2%
Subarachnoid haemorrhage
1%
Spinal fracture
1%
Hypoglycaemia
1%
Device dislocation
1%
Myocardial infarction
1%
Agitation
1%
Gastrointestinal haemorrhage
1%
Tachycardia
1%
Cardiac failure
1%
Cardiac failure chronic
1%
Cerebrovascular accident
1%
Pneumonia
1%
Bacteraemia
1%
Cellulitis
1%
Gastroenteritis
1%
Infection
1%
Septic shock
1%
Small intestinal obstruction
1%
Respiratory failure
1%
Pleural effusion
1%
Lung cancer metastatic
1%
Metastases to liver
1%
Haemorrhagic anaemia
1%
Hepatic failure
1%
Renal failure acute
1%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fresh Frozen Plasma
Beriplex® P/N

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 3 - SerpinPC (Extension phase)Experimental Treatment1 Intervention
After completion of dosing in Part 1 or Part 2, participants will continue treatment with SerpinPC at the dose of SerpinPC selected for Part 2 in a 24-week extension phase (Part 3).
Group II: Part 2 - SerpinPC (Dose-confirmatory phase)Experimental Treatment1 Intervention
After a minimum of 24 weeks of prospective observation, participants will receive SerpinPC at dose of 1.2 mg/kg Q2W for 24 weeks in Part 2, unless the Interim Analysis (IA) shows a greater benefit-risk profile with either the 1.2 mg/kg QW or Q4W treatment regimens.
Group III: Part 1 - Cohort 3: SerpinPCExperimental Treatment1 Intervention
Participants will receive SerpinPC 1.2 mg/kg SC Injection Q4W for 24 weeks after a minimum of 12 weeks of a prospective observation period.
Group IV: Part 1 - Cohort 2: SerpinPCExperimental Treatment1 Intervention
Participants will receive SerpinPC 1.2 mg/kg SC Injection Q2W for 24 weeks after a minimum of 12 weeks of a prospective observation period.
Group V: Part 1 - Cohort 1: SerpinPCExperimental Treatment1 Intervention
Participants will receive SerpinPC 1.2 mg/kg SC Injection QW for 24 weeks after a minimum of 12 weeks of a prospective observation period.

Find a Location

Who is running the clinical trial?

ApcinteX LtdLead Sponsor
4 Previous Clinical Trials
401 Total Patients Enrolled
4 Trials studying Hemophilia A
401 Patients Enrolled for Hemophilia A
Centessa Pharmaceuticals plcIndustry Sponsor
9 Previous Clinical Trials
546 Total Patients Enrolled
4 Trials studying Hemophilia A
401 Patients Enrolled for Hemophilia A
~64 spots leftby Mar 2026
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