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HemophiliaPhase 2NCT06289166

Safety and Efficacy of STSP-0601 in Adult Patients with Hemophilia a or B with Inhibitor

A Phase 2 study testing STSP-0601 for Injection in people with Hemophilia, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 20 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 inhibitor. Read more about this study

Who is it for?
Ages 18 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
25 participants
Where
20 sitesChina
Study dates
18 Mar 2024to 17 Oct 2024
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 ≤age≤70 years of age,male.
  • Hemophilia A or B patients. (No less than 3 patients with hemophilia B)
  • Peak historical inhibitor titer ≥ 5 BU and apositive inhibitor test when enrolled.
  • Establish proper venous access.
  • There were at least 3 bleeding events that requiring treatment occurred in the past 6 months before screening (Only applicable to the on-demand treatment stage).
  • Agree to use adequate contraception to avoid pregnancy. Agree not to donate sperm or eggs.
  • 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 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.
  • Platelet <100×109/L.
Show all 15Show fewer
  • 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.
  • 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 prior to enrollment, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days prior to enrollment, prothrombin complex, FVIII, and FIX were used. Within 4 weeks prior to enrollment, treatment with amisulumab was received.
  • Patients not suitable for the trail according to the judgment of the investigators.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

China20 sites

  • The first hospital of Jilin University

    Changchun, Jilin, 130000

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

  • Fujian Medical University Affiliated Union Medical College Hospital

    Fuzhou, Fujian, 350005

  • Southern Medical University Southern Hospital

    Guangzhou, Guangdong, 510000

  • Guizhou Medical University Affiliated Hospital

    Guiyang, Guizhou, 550000

  • Harbin First Hospital Hematology Tumor Research Center

    Harbin, Heilongjiang, 150000

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

  • 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, 330038

  • Nanjing University School of Medicine Affiliated Gulou Hospital

    Nanjing, Jiangsu, 210000

  • Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning, 110000

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518000

  • 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

Other trials in China

About this study

Official title: A Multi-center, Open-label, Phase Ⅱb Trial to Evaluate the Safety and Efficacy of STSP-0601 for Injection in Patients with Hemophilia with Inhibitor

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 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

    A Multiple-dose Design to Evaluate the Safety, Tolerability and Efficacy of STSP-0601 for Injection in hemophilia A or B patients with inhibitor.

Study groups in NCT06289166
Study groupRoleWhat they receive
Consecutive doses of STSP-0601ExperimentalNot described
Receives: Drug: STSP-0601 for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of successfully treated bleeding episodes

    Measured: 12 hours after first administration of study drug

Secondary outcomes (9)

  1. Proportion of successfully treated first bleeding episodes

    Measured: 12 hours after first administration of study drug

  2. Proportion of successfully treated bleeding episodes

    Measured: 8 hours after first administration of study drug

  3. Excellent + good rate of treated bleeding episodes

    Excellent: Pain and Symptoms of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage) had fully eased. No additional infusion of study drug was required.

    Good: Symptoms of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage) had largely eased , but had not completely disappeared. No additional infusion of study drug was required.

    Measured: 12 hours after first administration of study drug

  4. Excellent + good rate of treated bleeding episodes

    Excellent: Pain and Symptoms of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage) had fully eased. No additional infusion of study drug was required.

    Good: Symptoms of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage) had largely eased , but had not completely disappeared. No additional infusion of study drug was required.

    Measured: 8 hours after first administration of study drug

  5. Number of doses required for effective hemostasis

    Measured: 12 hours after first administration of study drug

  6. Proportion of bleeding episodes received salvage treatment

    Measured: 24 hours after first administration of study drug

  7. Time to complete/significant remission from first dose

    Measured: 72 hours after last administration of study drug

  8. Time to complete/significant remission from haematogenesis

    Measured: 72 hours after last administration of study drug

  9. Proportion of successfully treated Target joint bleeding episodes

    Measured: 12 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.

  1. First posted1 Mar 2024
  2. Study start18 Mar 2024
  3. Primary completion17 Oct 2024
  4. Study completion17 Oct 2024

Resources

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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06289166
Sponsor's protocol ID
STSP-0601-04
Status last verified
Jan 2025
First submitted
23 Feb 2024
Last updated
22 Jan 2025
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 41637644

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 20 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: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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?

Proportion of successfully treated bleeding episodes (time frame: 12 hours after first administration of study drug). 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 NCT06289166, 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 22 Jan 2025.

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