HemophiliaPhase 2NCT05619926
Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor
A Phase 2 study testing STSP-0601 for Injection in people with Hemophilia, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 12 sites in China.
Trial summary
This study will assess the safety,efficacy,pharmacokinetics and pharmacodynamics of multiple-dose of STSP-0601 at two dose levels for the treatment of bleeding episodes in hemophilia A or B patients without inhibitor. Read more about this study
- Who is it for?
- Ages 18 to 70 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
- 32 participants
- Where
- 12 sitesChina
- Study dates
- 9 Jan 2023to 25 Aug 2023
- Phase
- Phase 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 ≤age≤70 years of age,male;
- Hemophilia A or B patients;
- A bleeding event requiring treatment occurred (Only applicable to the on-demand treatment stage);
- Factor VIII or IX level <2%, inhibitor titer < 0.6 BU;
- There were at least 2 bleeding events that requiring treatment occurred in the past 6 months before screening (Only the second stage is applicable);
- 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;
- Plan to receive prophylactic treatment of coagulation factor during the trail;
- 4 weeks before screening, receive prophylactic treatment of amesetuzumab or plan to receive prophylactic treatment of amesetuzumab during the trial;
- Patients received anticoagulant or antifibrinolytic therapy 7 days before enrollment or plan to receive these drugs during the trial;
- Patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment;
- Have a history of arterial and/or venous thrombotic events;
Show all 15Show fewer
- Platelet <100×109/L;
- Hemoglobin<90g/L;
- Severe liver or kidney disease;
- Severe bleeding event occurred within 4 weeks before enrollment;
- Accepted major operation or blood transfusion within 4 weeks before enrollment;
- HIV positive;
- Have a known allergy to STSP-0601;
- Participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails);
- Patients not suitable for the trail according to the judgment of the investigators.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000
Lanzhou University First Hospita
Lanzhou, Gansu, 730000
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330038
Nanjing Gulou Hospital
Nanjing, Jiangsu, 210000
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473000
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 511285
North China University of Technology Affiliated Hospital
Tangshan, Hebei, 063000
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Xi'an Central Hospital
Xi’an, Shanxi, 710000
Henan Cancer Hospital
Zhengzhou, Henan, 450000
About this study
Official title: A Multi-center, Open-label, Multiple-dose Design, Phase 2 Trial to Evaluate the Safety and Efficacy of STSP-0601 for Injection in Patients With Hemophilia Without Inhibitor
This study will assess the safety,efficacy,pharmacokinetics and pharmacodynamics of multiple-dose of STSP-0601 at two dose levels for the treatment of bleeding episodes in hemophilia A or B patients without 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
Intravenous Injection
| 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 4
Proportion of successfully treated bleeding episodes
Measured: 8 hours after first administration of study drug
Secondary outcomes (2)
Proportion of successfully treated bleeding episodes
Measured: 12 hours，24 hours after first administration of study drug
Proportion of bleeding episodes received salvage treatment
Measured: Within 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start9 Jan 2023
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Novikang Medical Technology Co., LTD
- Responsible party
- Sponsor
- Investigators
- Lei Zhang, MD, Principal investigator, Affiliation:Hospital of Hematology, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619926
- Sponsor's protocol ID
- STSP-0601-03
- Status last verified
- Aug 2023
- First submitted
- 9 Nov 2022
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Multiple-dose Design, Phase 2 Trial to Evaluate the Safety and Efficacy of STSP-0601 for Injection in Patients With Hemophilia Without Inhibitor
- ClinicalTrials.gov ID
- NCT05619926
- Acronym / sponsor ID
- STSP-0601-03
- Conditions
- Hemophilia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Novikang Medical Technology Co., LTD
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 17 Nov 2022 (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,efficacy,pharmacokinetics and pharmacodynamics of multiple-dose of STSP-0601 at two dose levels for the treatment of bleeding episodes in hemophilia A or B patients without inhibitor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-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 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 ≤age≤70 years of age,male;
- Hemophilia A or B patients;
- A bleeding event requiring treatment occurred (Only applicable to the on-demand treatment stage);
- Factor VIII or IX level <2%, inhibitor titer < 0.6 BU;
- There were at least 2 bleeding events that requiring treatment occurred in the past 6 months before screening (Only the second stage is applicable);
Key exclusion criteria (15 listed)
- Have any coagulation disorder other than hemophilia;
- Plan to receive prophylactic treatment of coagulation factor during the trail;
- 4 weeks before screening, receive prophylactic treatment of amesetuzumab or plan to receive prophylactic treatment of amesetuzumab during the trial;
- Patients received anticoagulant or antifibrinolytic therapy 7 days before enrollment or plan to receive these drugs during the trial;
- Patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment;
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 InjectionIntravenous Injection | Drug | Consecutive doses of high-dose of STSP-0601, Consecutive doses of low-dose of STSP-0601 |
Primary outcome
Incidence of adverse events
Time frame: From day 0 to up to day 4
Proportion of successfully treated bleeding episodes
Time frame: 8 hours after first administration of study drug
2 secondary outcomes
Proportion of successfully treated bleeding episodes
Time frame: 12 hours，24 hours after first administration of study drug
Proportion of bleeding episodes received salvage treatment
Time frame: Within 3 months after enrollment
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 2 Jan 2024.
- Individual participant dataSharing planned: No
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, MD principal investigator
Affiliation:Hospital of Hematology, Chinese Academy of Medical Sciences
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STSP-0601 for Injection in people with Hemophilia, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 12 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 8 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: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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 4). 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?
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 2 Jan 2024.