CompletedPhase 1

A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor

China16 participantsStarted 2020-01-15

Plain-language summary

This study will assess the pharmacokinetics and pharmacodynamics of STSP-0601 at six dose levels. The results will help identify the most optimal doses to treat bleedings in hemophilia patients with inhibitors.

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

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 years old ≤age≤65 years of age,male. * Hemophilia A or B patients with inhibitors. * Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled. * Establish proper venous access. * Provide signed informed consent. Exclusion Criteria: * Have any coagulation disorder other than hemophilia A or B. * Treat with prophylactic treatment of coagulation factor. * Treat with anticoagulant within 7d of the time of study drug administration. * Have an active, ongoing bleeding for which the patient is being treated, or treatment for a bleeding was stopped within 7d of the time of study drug administration. * Have a history of arterial and/or venous thromboembolic events. * Have platelet count \<100,000/mL. * Severe liver or kidney disease. * Accept major operation or blood transfusion within 1 month of the time of screening. * HIV antibody positive. * Have a known allergy to Blood product. * Participate in other clinical research within 1 month of the time of study drug administration.

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

Number of subjects of adverse events

Timeframe: Baseline to Day 8

Number of subjects With Significant Abnormal Physical Examination

Timeframe: Baseline to Day 8

Number of subjects of Significant Abnormal Vital Signs Findings

Timeframe: Baseline to Day 8

Number of Participants With Significant Abnormal Laboratory Values

Timeframe: Baseline to Day 8

Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings

Timeframe: Baseline,1 hour,4 hour,48 hour,Day 8

Trial details

NCT IDNCT04747964

SponsorStaidson (Beijing) Biopharmaceuticals Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-19

View on ClinicalTrials.gov More Hemophilia trials

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

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

What they're measuring

Number of subjects of adverse events

Timeframe: Baseline to Day 8

Number of subjects With Significant Abnormal Physical Examination

Timeframe: Baseline to Day 8

Number of subjects of Significant Abnormal Vital Signs Findings

Timeframe: Baseline to Day 8

Number of Participants With Significant Abnormal Laboratory Values

Timeframe: Baseline to Day 8

Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings

Timeframe: Baseline,1 hour,4 hour,48 hour,Day 8