NCT04747964

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2021

Completed
Last Updated

September 19, 2024

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

February 5, 2021

Last Update Submit

September 12, 2024

Conditions

Hemophilia

Outcome Measures

Primary Outcomes (5)

  • Number of subjects of adverse events

    Baseline to Day 8

  • Number of subjects With Significant Abnormal Physical Examination

    Baseline to Day 8

  • Number of subjects of Significant Abnormal Vital Signs Findings

    Baseline to Day 8

  • Number of Participants With Significant Abnormal Laboratory Values

    Baseline to Day 8

  • Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings

    Baseline,1 hour,4 hour,48 hour,Day 8

Secondary Outcomes (2)

  • Activated partial thromboplastin time

    Baseline to 24 hours

  • Thrombin production (TG) peak

    Baseline to 24 hours

Study Arms (6)

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

Interventions

STSP-0601 for InjectionDRUG

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

A single lowest dose of treatment group

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tianjin, China

Location

Related Publications (1)

  • 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.

    PMID: 36796484DERIVED

MeSH Terms

Conditions

Hemophilia A

Interventions

Injections

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Lei Zhang

    Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 10, 2021

Study Start

January 15, 2020

Primary Completion

April 19, 2021

Study Completion

April 19, 2021

Last Updated

September 19, 2024

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)