CompletedPhase 2

Safety and Efficacy of STSP-0601 in Adult Patients with Hemophilia a or B with Inhibitor

China25 participantsStarted 2024-03-18

Plain-language summary

This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 18 ≤age≤70 years of age,male.
. Hemophilia A or B patients. (No less than 3 patients with hemophilia B)
. Peak historical inhibitor titer ≥ 5 BU and apositive inhibitor test when enrolled.
. Establish proper venous access.
. There were at least 3 bleeding events that requiring treatment occurred in the past 6 months before screening (Only applicable to the on-demand treatment stage).
. Agree to use adequate contraception to avoid pregnancy. Agree not to donate sperm or eggs.
. Provide signed informed consent.

Exclusion criteria

. Have any coagulation disorder other than hemophilia.
. Plan to receive prophylactic treatment of coagulation factor during the trail.
. Patients plan to receive Emicizumab during the trial.
. Patients received anticoagulant or antifibrinolytic therapy 7 days before enrollment or plan to receive these drugs during the trial.Patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of successfully treated bleeding episodes

Timeframe: 12 hours after first administration of study drug

Trial details

NCT IDNCT06289166

SponsorStaidson (Beijing) Biopharmaceuticals Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-17

View on ClinicalTrials.gov More Hemophilia trials