SerpinPC for Hemophilia (PRESent-6 Trial)

Phase 3

Recruiting

Research Sponsored by ApcinteX Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male participants aged between 12 and 65 at the time of informed consent

Must not have

History of deep vein thrombosis, pulmonary embolism, myocardial infarction, or embolic stroke

Current treatment with anticoagulant or antiplatelet drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to test how well SerpinPC works in preventing bleeding episodes in people with hemophilia, while also looking at its safety and how the body processes the drug.

Who is the study for?

This trial is for males aged 12-65 with Hemophilia who have already completed a SerpinPC clinical trial and were compliant. They must be able to give informed consent, or if underage, obtain parental/guardian consent.

What is being tested?

The study aims to assess the long-term effects of SerpinPC on people with Hemophilia. It looks at how well it works (efficacy), its safety, how the body tolerates it (tolerability), and how the body processes it (pharmacokinetics).

What are the potential side effects?

While specific side effects are not listed here, common concerns in such trials include potential allergic reactions to the medication, issues related to blood clotting abilities, and general discomforts like headaches or nausea.

Eligibility Criteria

Inclusion Criteria

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

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I am a male between 12 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a blood clot, heart attack, or stroke.

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I am currently taking medication to prevent blood clots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SerpinPCExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met