HemophiliaPhase 1/2NCT05027230
A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
A Phase 1/2 study testing STSP-0601 for Injection in people with Hemophilia, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in China.
Trial 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 inhibitors. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- 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
- 77 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2021to 29 Jul 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤age≤65 years of age,male.
- Hemophilia A or B patients with inhibitors.
- Received hemostatic treatment with investigational drug, or to undergo minor surgical or other invasive procedures (Only for phase 2. Minor surgical procedures: procedures without general anesthesia and the wounds are easy to observe).
- Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
- Establish proper venous access.
- Agree to use adequate contraception to avoid pregnancy.
- Provide signed informed consent.
Who cannot join
- 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 a history of arterial and/or venous thromboembolic events.
- Have platelet <100,000/mL,hemoglobin<90g/L.
- Severe liver or kidney disease.
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- Bleeding in the central nervous system or throat before screening.
- Accept major operation or blood transfusion within 1 month of the time of screening.
- HIV positive with current CD4+ count of less than 200/μl.
- Have a known allergy to Blood product.
- Participate in other clinical research within 1 month of the time of study drug administration.
- Treat with coagulant within 7d of the time of study drug administration.
Trial locations and contacts
1 site in 1 country.
China1 site
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
About this study
Official title: A Phase Ib/II,Multi-center, Open, Multiple-dose Design to Evaluate the Safety,Tolerability and Efficacy of STSP-0601 for Injection in Patients With Inhibitory Hemophilia
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 inhibitors.
- 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
A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia
STSP-0601 for InjectionDrug
A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia
| Study group | Role | What they receive |
|---|---|---|
| Consecutive doses of low-dose of STSP-0601 | Experimental | Not described Receives: Drug: STSP-0601 for Injection |
| Consecutive doses of high-dose 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.
Incidence of adverse events
Measured: From day 0 to up to day 8
Proportion of successfully treated bleeding episodes
Measured: 24 hours after administration of study drug
Secondary outcomes (1)
Proportion of bleeding episodes with clinical relief of signs and symptoms
Measured: 4 hours、8 hours、24 hours after first administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start12 Oct 2021
- Primary completion15 Jul 2023
- Study completion29 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals 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
- NCT05027230
- Sponsor's protocol ID
- STSP-0601-02
- Status last verified
- Sep 2024
- First submitted
- 25 Aug 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu W, Zhou H, Huang R, Du X, Wang P, Zhou Z, Zheng C, Lou S, Ma J, Song Y, Dai X, Wang X, Yang R, Zhang L. A specific FX activator for bleeding treatment in hemophilia with inhibitors: multicenter, open-label, phase 1/2 trials. Blood Adv. 2026 May 12;10(9):3002-3010. doi: 10.1182/bloodadvances.2025019486.
PubMed 41637644Liu W, Xue F, Fu R, Ding B, Li M, Sun T, Chen Y, Liu X, Ju M, Dai X, Wu Q, Zhou Z, Yu J, Wang X, Zhu Q, Zhou H, Yang R, Zhang L. Preclinical studies of a factor X activator and a phase 1 trial for hemophilia patients with inhibitors. J Thromb Haemost. 2023 Jun;21(6):1453-1465. doi: 10.1016/j.jtha.2023.01.040. Epub 2023 Feb 14.
PubMed 36796484
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II,Multi-center, Open, Multiple-dose Design to Evaluate the Safety,Tolerability and Efficacy of STSP-0601 for Injection in Patients With Inhibitory Hemophilia
- ClinicalTrials.gov ID
- NCT05027230
- Acronym / sponsor ID
- STSP-0601-02
- Conditions
- Hemophilia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 29 Jul 2023 (actual)
- First posted
- 30 Aug 2021 (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 safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consecutive doses of low-dose of STSP-0601 | Experimental | Drug: STSP-0601 for Injection |
| Consecutive doses of high-dose of STSP-0601 | Experimental | Drug: STSP-0601 for Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old ≤age≤65 years of age,male.
- Hemophilia A or B patients with inhibitors.
- Received hemostatic treatment with investigational drug, or to undergo minor surgical or other invasive procedures (Only for phase 2. Minor surgical procedures: procedures without general anesthesia and the wounds are easy to observe).
- Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
- Establish proper venous access.
Key exclusion criteria (12 listed)
- 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 a history of arterial and/or venous thromboembolic events.
- Have platelet <100,000/mL,hemoglobin<90g/L.
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 InjectionA multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia | Drug | Consecutive doses of low-dose of STSP-0601 |
| STSP-0601 for InjectionA multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia | Drug | Consecutive doses of high-dose of STSP-0601 |
Primary outcome
Incidence of adverse events
Time frame: From day 0 to up to day 8
Proportion of successfully treated bleeding episodes
Time frame: 24 hours after administration of study drug
1 secondary outcome
Proportion of bleeding episodes with clinical relief of signs and symptoms
Time frame: 4 hours、8 hours、24 hours after first administration of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41637644Liu W, Zhou H, Huang R, Du X, Wang P, Zhou Z, Zheng C, Lou S, Ma J, Song Y, Dai X, Wang X, Yang R, Zhang L. A specific FX activator for bleeding treatment in hemophilia with inhibitors: multicenter, open-label, phase 1/2 trials. Blood Adv. 2026 May 12;10(9):3002-3010. doi: 10.1182/bloodadvances.2025019486.
- Derived from this study: PubMed 36796484Liu W, Xue F, Fu R, Ding B, Li M, Sun T, Chen Y, Liu X, Ju M, Dai X, Wu Q, Zhou Z, Yu J, Wang X, Zhu Q, Zhou H, Yang R, Zhang L. Preclinical studies of a factor X activator and a phase 1 trial for hemophilia patients with inhibitors. J Thromb Haemost. 2023 Jun;21(6):1453-1465. doi: 10.1016/j.jtha.2023.01.040. Epub 2023 Feb 14.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing STSP-0601 for Injection in people with Hemophilia, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site 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 12 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of adverse events (time frame: From day 0 to up to day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05027230, which also lists 2 linked publications.
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 19 Sep 2024.