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New hope for hemophilia patients with inhibitors: STSP-0601 enters phase 3 trial

NCT ID NCT06922045

Disease control Sponsor: Jiangsu BioJeTay Biotechnology Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This Phase 3 trial is testing STSP-0601, an injectable drug, to control bleeding episodes in people with hemophilia A or B who have developed inhibitors (antibodies that block standard treatment). The study will enroll 40 participants aged 12 to 70 and measure how well the drug stops bleeding within 12 hours. If effective, STSP-0601 could offer a new way to manage bleeds in this challenging patient group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
STSP-0601 injection
What this could lead to
If successful, this could provide a new treatment option to control bleeding episodes in hemophilia patients with inhibitors, reducing the need for other therapies.
What could go wrong
This is a small Phase 3 trial with only 40 participants, so results may not apply to all patients. The drug may not achieve effective hemostasis in all cases, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

40 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 12 ≤age≤70 years of age. 2. Hemophilia A or B patients. 3. Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled. 4. Establish proper venous access. 5. There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening. 6. Agree to use adequate contraception to avoid pregnancy. 7. Provide signed informed consent. Exclusion Criteria: 1. Have any coagulation disorder other than hemophilia. 2. Plan to receive prophylactic treatment of coagulation factor during the trail. 3. Patients plan to receive Emicizumab during the trial. 4. Patients received anticoagulant or antifibrinolytic therapy 7 days before the first administration or plan to receive these drugs during the trial. 5. Have a history of arterial and/or venous thrombotic events. 6. Platelet \<100×109/L. 7. Hemoglobin\<90g/L. 8. Severe liver or kidney disease. 9. Severe bleeding event occurred within 4 weeks before the first administration. 10. Accepted major operation or blood transfusion within 4 weeks before the first administration. 11. Have a known allergy to STSP-0601. 12. Pregnant, lactating, or blood pregnancy test positive female subjects 13. Participate in other clinical research within 4 weeks before enrollment (except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails). 14. Within 1 day before the first administration, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days before the first administration, prothrombin complex, FVIII, and FIX were used. Within 4 weeks, treatment with Emicizumab was received. 15. Patients not suitable for the trail according to the judgment of the investigators.

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Conditions

The condition(s) this trial relates to.

hemophilia hemophilia A hemophilia B

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemophilia

Contacts and locations

Locations

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001, China

  • Harbin First Hospital Hematology Tumor Research Center

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 300020, China

  • Hospital of Hematology, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020, China

  • Huazhong University of Science and Technology Union Hospital

    Wuhan, Hubei, 430022, China

  • Jiangsu Provincial Hospital

    Nanjing, Jiangsu, 210029, China

  • Jinan Central Clinical College of Shandong First Medical University

    Jinan, Shandong, 250013, China

  • Lanzhou University First Hospital

    Lanzhou, Gansu, 730000, China

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • North China University of Science and Technology Affiliated Hospital

    Tangshan, Hebei, 063000, China

  • Second hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001, China

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518000, China

  • Sichuan Academy of Medical Sciences＆Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000, China

  • The First affiliated hospital of Guangxi Medical University

    Nanning, Guangxi, 530021, China

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650000, China

  • Wenzhou People's Hospital

    Wenzhou, Zhejiang, 325000, China

  • Xi'an Central Hospital

    Xi’an, Shanxi, 710000, China

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