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Protease Inhibitor

SerpinPC for Hemophilia B (PRESent-3 Trial)

Q: How many participants are engaged in this experiment?

12 volunteers, that adhere to the outlined inclusion criteria, are necessary in order for this study to go ahead. Patients can enroll at Royal Prince Alfred Hospital in Camperdown, <a href="https://www.withpower.com/clinical-trials/colorado">Colorado</a> and University of Colorado School of Medicine in Aurora, Victoria.

Q: Is it currently possible to join this research project?

Data from clinicaltrials.gov supports the notion that this medical research is actively searching for participants, with it having initially been posted on July 28th 2023 and last updated on December 12th of the same year.

Q: How prevalent are the medical research programs being conducted in this urban area?

The 10 participating sites for this clinical trial include the Royal Prince Alfred Hospital in Camperdown, University of <a href="https://www.withpower.com/clinical-trials/colorado">Colorado</a> School of Medicine in Aurora and Hopital Bicetre in Le Kremlin-Bicêtre. Additionally, there are 7 other healthcare facilities that have joined this research effort.

Q: Has the FDA sanctioned SerpinPC for medical use?

Our team at Power gave SerpinPC a rating of 2 on the scale of 1 to 3 due to its Phase 2 trial status, indicating that there is some safety data associated with it but none proving efficacy.

Q: Is the age range for participants in this trial expansive enough to include individuals over 40?

To qualify for this clinical trial, applicants must be between 12 and 65 years old. For those younger than 12 or older than 65 there are 53 trials available and 74 respectively.

Q: What population is most likely to benefit from participating in this clinical trial?

This investigation is seeking 12 male participants between the ages of twelve and sixty-five with Hemophilia B. <a href="https://www.withpower.com/clinical-trials/all">All</a> candidates must possess a Factor IX concentration that is equal to or less than 0.05 IU/mL, as well as an Annualized Bleeding Rate (ABR) of 6 within the past year for those not on a prophylaxis regimen, and 2 ABRs for individuals currently undergoing such treatment. In addition, all applicants should have no bleeding in the week prior to baseline screening and D-dimer levels at or below 750 mc/L; this threshold can be extended up to 1750 mg/L if

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

Participants who are currently in a prophylaxis program must be willing to stop prophylaxis (including episodic prophylaxis for sporting events) before the first dose of SerpinPC.

Male participants greater than or equal to (>=) 12 and less than or equal to (<=) 65 years of age at the time of informed consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1(pre-dose) up to week 48(post-dose)

Awards & highlights

PRESent-3 Trial Summary

This trial studies a new medicine to help treat hemophilia B with inhibitors. It looks at safety, effectiveness, and how the body processes it.

Who is the study for?

This trial is for males aged 12-65 with Hemophilia B and inhibitors, who haven't bled in the week before starting. They must have a history of frequent bleeding episodes and be willing to stop current prophylaxis treatments. Participants need normal platelet counts and hemoglobin levels, plus documented bleeding history or agree to an observation period.Check my eligibility

What is being tested?

The study tests SerpinPC's effectiveness, safety, tolerability, and how it moves through the body when used as a preventive treatment in those with Hemophilia B with inhibitors. It aims to become part of the standard care for these patients.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones associated with new hemophilia treatments may include reactions at injection sites, headaches, nausea, allergic reactions or development of antibodies that might reduce treatment efficacy.

PRESent-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am willing to stop my current prophylaxis before starting SerpinPC.

Select...

I am a male between 12 and 65 years old.

Select...

My blood tests show enough platelets and hemoglobin.

Select...

I have a history of Factor IX inhibitor with treatment.

PRESent-3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1(pre-dose) up to week 48(post-dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1(pre-dose) up to week 48(post-dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1(pre-dose) up to week 48(post-dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Annualized Bleeding Rate (ABR) for Treated Bleeds up to Week 24

Secondary outcome measures

Annualized Bleeding Rate (ABR) for Treated Bleeds Up to Week 48

Annualized Bleeding Rate (ABR) for Treated Spontaneous Bleeds

Annualized Bleeding Rate (ABR) for Treated Spontaneous Joint Bleeds

+6 more

Side effects data

From 2010 Phase 3 trial • 216 Patients • NCT00708435

Constipation

Oedema peripheral

Hypokalaemia

Diarrhoea

Cardiac failure congestive

Pyrexia

Headache

Pulmonary oedema

Insomnia

Hypomagnesaemia

Nausea

Dyspnoea

Chest pain

Hyperkalaemia

Fluid overload

Urinary tract infection

Hypotension

Rash

Anxiety

Anaemia

Vomiting

Myocardial ischaemia

Encephalopathy

Subarachnoid haemorrhage

Device dislocation

Spinal fracture

Myocardial infarction

Hypoglycaemia

Agitation

Gastrointestinal haemorrhage

Tachycardia

Cardiac failure

Cardiac failure chronic

Cerebrovascular accident

Pneumonia

Bacteraemia

Cellulitis

Gastroenteritis

Infection

Septic shock

Small intestinal obstruction

Respiratory failure

Pleural effusion

Lung cancer metastatic

Metastases to liver

Haemorrhagic anaemia

Hepatic failure

Renal failure acute

Arthralgia

100%

80%

60%

40%

20%

Study treatment Arm

Fresh Frozen Plasma

Beriplex® P/N

PRESent-3 Trial Design

1Treatment groups

Experimental Treatment

Group I: SerpinPCExperimental Treatment1 Intervention

Participants will receive SerpinPC 1.2 milligrams/kilogram (mg/kg) subcutaneous (SC) injection every 2 weeks (Q2W) for 48 weeks after a prospective observation of 12 weeks for all participants, either in a prior non-interventional study (AP-0105[NCT05605678]) or as part of the ongoing study observational period.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centessa Pharmaceuticals plcIndustry Sponsor

8 Previous Clinical Trials

504 Total Patients Enrolled

3 Trials studying Hemophilia B

359 Patients Enrolled for Hemophilia B

ApcinteX LtdLead Sponsor

3 Previous Clinical Trials

359 Total Patients Enrolled

3 Trials studying Hemophilia B

359 Patients Enrolled for Hemophilia B

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in this experiment?

"12 volunteers, that adhere to the outlined inclusion criteria, are necessary in order for this study to go ahead. Patients can enroll at Royal Prince Alfred Hospital in Camperdown, Colorado and University of Colorado School of Medicine in Aurora, Victoria."

Answered by AI

Is it currently possible to join this research project?

"Data from clinicaltrials.gov supports the notion that this medical research is actively searching for participants, with it having initially been posted on July 28th 2023 and last updated on December 12th of the same year."

Answered by AI

How prevalent are the medical research programs being conducted in this urban area?

"The 10 participating sites for this clinical trial include the Royal Prince Alfred Hospital in Camperdown, University of Colorado School of Medicine in Aurora and Hopital Bicetre in Le Kremlin-Bicêtre. Additionally, there are 7 other healthcare facilities that have joined this research effort."

Answered by AI

Has the FDA sanctioned SerpinPC for medical use?

"Our team at Power gave SerpinPC a rating of 2 on the scale of 1 to 3 due to its Phase 2 trial status, indicating that there is some safety data associated with it but none proving efficacy."

Answered by AI

Is the age range for participants in this trial expansive enough to include individuals over 40?

"To qualify for this clinical trial, applicants must be between 12 and 65 years old. For those younger than 12 or older than 65 there are 53 trials available and 74 respectively."

Answered by AI

What population is most likely to benefit from participating in this clinical trial?

"This investigation is seeking 12 male participants between the ages of twelve and sixty-five with Hemophilia B. All candidates must possess a Factor IX concentration that is equal to or less than 0.05 IU/mL, as well as an Annualized Bleeding Rate (ABR) of 6 within the past year for those not on a prophylaxis regimen, and 2 ABRs for individuals currently undergoing such treatment. In addition, all applicants should have no bleeding in the week prior to baseline screening and D-dimer levels at or below 750 mc/L; this threshold can be extended up to 1750 mg/L if"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of SerpinPC in Participants With Hemophilia B (HemB) With Inhibitors

2023. "A Study of SerpinPC in Participants With Hemophilia B (HemB) With Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05789537.

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