HemophiliaPhase 3NCT06922045
Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients
A Phase 3 study testing STSP-0601 for Injection in people with Hemophilia, run by Jiangsu BioJeTay Biotechnology Co., Ltd. at 18 sites in China.
Trial summary
This study will assess the efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Hemophilia
- What is being tested?
- STSP-0601 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 18 sitesChina
- Study dates
- 26 Mar 2025to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 ≤age≤70 years of age.
- Hemophilia A or B patients.
- Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
- Establish proper venous access.
- There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.
- Agree to use adequate contraception to avoid pregnancy.
- Provide signed informed consent.
Who cannot join
- 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 the first administration or plan to receive these drugs during the trial.
- Have a history of arterial and/or venous thrombotic events.
- Platelet <100×109/L.
Show all 15Show fewer
- Hemoglobin<90g/L.
- Severe liver or kidney disease.
- Severe bleeding event occurred within 4 weeks before the first administration.
- Accepted major operation or blood transfusion within 4 weeks before the first administration.
- Have a known allergy to STSP-0601.
- Pregnant, lactating, or blood pregnancy test positive female subjects
- Participate in other clinical research within 4 weeks before enrollment (except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
- 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.
- Patients not suitable for the trail according to the judgment of the investigators.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Sichuan Academy of Medical Sciences＆Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Harbin First Hospital Hematology Tumor Research Center
Harbin, Heilongjiang, 150000
Anhui Provincial Hospital
Hefei, Anhui, 230001
Jinan Central Clinical College of Shandong First Medical University
Jinan, Shandong, 250013
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000
Lanzhou University First Hospital
Lanzhou, Gansu, 730000
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
Jiangsu Provincial Hospital
Nanjing, Jiangsu, 210029
The First affiliated hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518000
Second hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, 063000
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Wenzhou People's Hospital
Wenzhou, Zhejiang, 325000
Huazhong University of Science and Technology Union Hospital
Wuhan, Hubei, 430022
Xi'an Central Hospital
Xi’an, Shanxi, 710000
Henan Cancer Hospital
Zhengzhou, Henan, 300020
About this study
Official title: A Phase III Clinical Study on the Efficacy and Safety of STSP-0601 for Injection in Patients With Hemophilia Associated With Inhibitors, With a Multicenter, Open Evaluation Approach
This study will assess the efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor
- Conditions
- Hemophilia
- Being tested
- STSP-0601 for Injection
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STSP-0601 for InjectionDrug
Evaluation of the Efficacy of Single-Dose and Continuous Administration of STSP-0601 Injection for the Treatment of Bleeding in Patients with Hemophilia A or B with Inhibitors
| Study group | Role | What they receive |
|---|---|---|
| Continuous administration of STSP-0601 | Experimental | Not described Receives: Drug: STSP-0601 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 hours effective hemostasis rate
Measured: 12 hours after the first administration
Secondary outcomes (11)
Effective hemostasis rate at the first 12 hours bleeding visit
Measured: 12 hours after the first administration
12 hours excellent + good rate
Measured: 12 hours after the first administration
The number of medication required for effective hemostasis within 12 hours
Measured: 12 hours after the first administration
The amount of medication (U/kg) required for effective hemostasis within 12 hours
Measured: 12 hours after the first administration
8-hours effective hemostasis rate
Measured: 8 hours after the first administration
8-hours excellent + good rate
Measured: 8 hours after the first administration
Complete + significant relief rate
Measured: 4 hours, 8 hours, 12 hours, 24 hours after the first administration
The time to achieve complete/significant remission after the first administration
Measured: From the time after the first administration until within 72 hours after the last administration
Rescue treatment rate
Measured: Within 72 hours after the last administration
The time from the onset of bleeding to complete/significant relief
Measured: Within 72 hours after the last administration
The effective hemostasis rate of the target joint
Measured: From 12 hours after the first administration to 72 hours after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start26 Mar 2025
- Primary completionSep 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu BioJeTay Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lei Zhang, Ph.D, Principal investigator, Hospital of Hematology, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922045
- Sponsor's protocol ID
- STSP-0601-05
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Study on the Efficacy and Safety of STSP-0601 for Injection in Patients With Hemophilia Associated With Inhibitors, With a Multicenter, Open Evaluation Approach
- ClinicalTrials.gov ID
- NCT06922045
- Acronym / sponsor ID
- STSP-0601-05
- Conditions
- Hemophilia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jiangsu BioJeTay Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous administration of STSP-0601 | Experimental | Drug: STSP-0601 for Injection |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 12 ≤age≤70 years of age.
- Hemophilia A or B patients.
- Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
- Establish proper venous access.
- There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.
Key exclusion criteria (15 listed)
- 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 the first administration or plan to receive these drugs during the trial.
- Have a history of arterial and/or venous thrombotic events.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STSP-0601 for InjectionEvaluation of the Efficacy of Single-Dose and Continuous Administration of STSP-0601 Injection for the Treatment of Bleeding in Patients with Hemophilia A or B with Inhibitors | Drug | Continuous administration of STSP-0601 |
Primary outcome
12 hours effective hemostasis rate
Time frame: 12 hours after the first administration
11 secondary outcomes
Effective hemostasis rate at the first 12 hours bleeding visit
Time frame: 12 hours after the first administration
12 hours excellent + good rate
Time frame: 12 hours after the first administration
The number of medication required for effective hemostasis within 12 hours
Time frame: 12 hours after the first administration
The amount of medication (U/kg) required for effective hemostasis within 12 hours
Time frame: 12 hours after the first administration
8-hours effective hemostasis rate
Time frame: 8 hours after the first administration
8-hours excellent + good rate
Time frame: 8 hours after the first administration
Complete + significant relief rate
Time frame: 4 hours, 8 hours, 12 hours, 24 hours after the first administration
The time to achieve complete/significant remission after the first administration
Time frame: From the time after the first administration until within 72 hours after the last administration
Rescue treatment rate
Time frame: Within 72 hours after the last administration
The time from the onset of bleeding to complete/significant relief
Time frame: Within 72 hours after the last administration
The effective hemostasis rate of the target joint
Time frame: From 12 hours after the first administration to 72 hours after the last administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
Related trials for Hemophilia
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Zhang, Ph.D principal investigator
Hospital of Hematology, Chinese Academy of Medical Sciences
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing STSP-0601 for Injection in people with Hemophilia, run by Jiangsu BioJeTay Biotechnology Co., Ltd. at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 hours effective hemostasis rate (time frame: 12 hours after the first administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.