HemophiliaPhase 1NCT04747964
A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
A Phase 1 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 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. 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
- 16 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2020to 19 Apr 2021
- Phase
- Phase 1
- 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.
- Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
- Establish proper venous access.
- 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 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin
About this study
Official title: A Phase 1,Multi-center, Randomized, Open, Single-dose Escalation Design to Evaluate the Safety, Tolerability and Pharmacodynamics of STSP-0601 for Injection in Patients With Inhibitory Hemophilia
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.
- 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
Subjects will receive one single lowest dose of STSP-0601 for Injection following protocol requirements
STSP-0601 for InjectionDrug
Subjects will receive one single low dose of STSP-0601 for Injection following protocol requirements
STSP-0601 for InjectionDrug
Subjects will receive one single low-intermediate dose of STSP-0601 for Injection following protocol requirements
STSP-0601 for InjectionDrug
Subjects will receive one single intermediate dose of STSP-0601 for Injection following protocol requirements
STSP-0601 for InjectionDrug
Subjects will receive one single high dose of STSP-0601 for Injection following protocol requirements
STSP-0601 for InjectionDrug
Subjects will receive one single highest dose of STSP-0601 for Injection following protocol requirements
| Study group | Role | What they receive |
|---|---|---|
| A single lowest dose of treatment group | Experimental | Not described Receives: Drug: STSP-0601 for Injection |
| A single low dose of treatment group | Experimental | Not described Receives: Drug: STSP-0601 for Injection |
| A single low-intermediate dose of treatment group | Experimental | Not described Receives: Drug: STSP-0601 for Injection |
| A single intermediate dose of treatment group | Experimental | Not described Receives: Drug: STSP-0601 for Injection |
| A single high dose of treatment group | Experimental | Not described Receives: Drug: STSP-0601 for Injection |
| A single highest dose of treatment group | 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.
Number of subjects of adverse events
Measured: Baseline to Day 8
Number of subjects With Significant Abnormal Physical Examination
Measured: Baseline to Day 8
Number of subjects of Significant Abnormal Vital Signs Findings
Measured: Baseline to Day 8
Number of Participants With Significant Abnormal Laboratory Values
Measured: Baseline to Day 8
Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
Measured: Baseline,1 hour,4 hour,48 hour,Day 8
Secondary outcomes (2)
Activated partial thromboplastin time
Measured: Baseline to 24 hours
Thrombin production (TG) peak
Measured: Baseline to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start15 Jan 2020
- Primary completion19 Apr 2021
- Study completion19 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lei Zhang, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747964
- Sponsor's protocol ID
- STSP-0601-01
- Status last verified
- Jul 2021
- First submitted
- 5 Feb 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, 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 1,Multi-center, Randomized, Open, Single-dose Escalation Design to Evaluate the Safety, Tolerability and Pharmacodynamics of STSP-0601 for Injection in Patients With Inhibitory Hemophilia
- ClinicalTrials.gov ID
- NCT04747964
- Acronym / sponsor ID
- STSP-0601-01
- Conditions
- Hemophilia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 19 Apr 2021 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 10 Feb 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A single lowest dose of treatment group | Experimental | Drug: STSP-0601 for Injection |
| A single low dose of treatment group | Experimental | Drug: STSP-0601 for Injection |
| A single low-intermediate dose of treatment group | Experimental | Drug: STSP-0601 for Injection |
| A single intermediate dose of treatment group | Experimental | Drug: STSP-0601 for Injection |
| A single high dose of treatment group | Experimental | Drug: STSP-0601 for Injection |
| A single highest dose of treatment group | 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 (5 listed)
- 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.
Key exclusion criteria (11 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 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.
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 InjectionSubjects will receive one single lowest dose of STSP-0601 for Injection following protocol requirements | Drug | A single lowest dose of treatment group |
| STSP-0601 for InjectionSubjects will receive one single low dose of STSP-0601 for Injection following protocol requirements | Drug | A single low dose of treatment group |
| STSP-0601 for InjectionSubjects will receive one single low-intermediate dose of STSP-0601 for Injection following protocol requirements | Drug | A single low-intermediate dose of treatment group |
| STSP-0601 for InjectionSubjects will receive one single intermediate dose of STSP-0601 for Injection following protocol requirements | Drug | A single intermediate dose of treatment group |
| STSP-0601 for InjectionSubjects will receive one single high dose of STSP-0601 for Injection following protocol requirements | Drug | A single high dose of treatment group |
| STSP-0601 for InjectionSubjects will receive one single highest dose of STSP-0601 for Injection following protocol requirements | Drug | A single highest dose of treatment group |
Primary outcome
Number of subjects of adverse events
Time frame: Baseline to Day 8
Number of subjects With Significant Abnormal Physical Examination
Time frame: Baseline to Day 8
Number of subjects of Significant Abnormal Vital Signs Findings
Time frame: Baseline to Day 8
Number of Participants With Significant Abnormal Laboratory Values
Time frame: Baseline to Day 8
Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
Time frame: Baseline,1 hour,4 hour,48 hour,Day 8
2 secondary outcomes
Activated partial thromboplastin time
Time frame: Baseline to 24 hours
Thrombin production (TG) peak
Time frame: Baseline to 24 hours
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 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 principal investigator
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 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 5 inclusion and 11 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 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.
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?
Number of subjects of adverse events (time frame: Baseline to Day 8). The study lists 5 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 NCT04747964, which also lists 1 linked publication.
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.