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A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor

NCT ID: NCT04747964

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2021-04-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A single lowest dose of treatment group

Group Type EXPERIMENTAL

STSP-0601 for Injection

Intervention Type DRUG

Subjects will receive one single lowest dose of STSP-0601 for Injection following protocol requirements

A single low dose of treatment group

Group Type EXPERIMENTAL

STSP-0601 for Injection

Intervention Type DRUG

Subjects will receive one single low dose of STSP-0601 for Injection following protocol requirements

A single low-intermediate dose of treatment group

Group Type EXPERIMENTAL

STSP-0601 for Injection

Intervention Type DRUG

Subjects will receive one single low-intermediate dose of STSP-0601 for Injection following protocol requirements

A single intermediate dose of treatment group

Group Type EXPERIMENTAL

STSP-0601 for Injection

Intervention Type DRUG

Subjects will receive one single intermediate dose of STSP-0601 for Injection following protocol requirements

A single high dose of treatment group

Group Type EXPERIMENTAL

STSP-0601 for Injection

Intervention Type DRUG

Subjects will receive one single high dose of STSP-0601 for Injection following protocol requirements

A single highest dose of treatment group

Group Type EXPERIMENTAL

STSP-0601 for Injection

Intervention Type DRUG

Subjects will receive one single highest dose of STSP-0601 for Injection following protocol requirements

Interventions

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STSP-0601 for Injection

Subjects will receive one single lowest dose of STSP-0601 for Injection following protocol requirements

Intervention Type DRUG

STSP-0601 for Injection

Subjects will receive one single low dose of STSP-0601 for Injection following protocol requirements

Intervention Type DRUG

STSP-0601 for Injection

Subjects will receive one single low-intermediate dose of STSP-0601 for Injection following protocol requirements

Intervention Type DRUG

STSP-0601 for Injection

Subjects will receive one single intermediate dose of STSP-0601 for Injection following protocol requirements

Intervention Type DRUG

STSP-0601 for Injection

Subjects will receive one single high dose of STSP-0601 for Injection following protocol requirements

Intervention Type DRUG

STSP-0601 for Injection

Subjects will receive one single highest dose of STSP-0601 for Injection following protocol requirements

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Staidson (Beijing) Biopharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lei Zhang

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Locations

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Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 36796484 (View on PubMed)

Other Identifiers

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STSP-0601-01

Identifier Type: -

Identifier Source: org_study_id

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