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Telitacicept in Primary APS Patients

Primary Purpose

Anti Phospholipid Syndrome

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Telitacicept
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anti Phospholipid Syndrome focused on measuring anti phospholipid syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • meet 2006 Sapporo classification criteria of APS;
  • diagnosis of primary APS, exclude other etiologies of thrombosis;
  • with three aPL medium-to-high titer positivity, namely lupus anticoagulant, anti cardiolipin antibody, and anti-β2 glycoprotein antibody;
  • with at least one extra-criteria manifestations of APS, including thrombocytopenia, hemolytic anemia, aPL nephropathy, valve heart disease and neurological manifestations.

Exclusion Criteria:

  • overlap with other connective tissue diseases, such as systemic lupus erythematosus;
  • during pregnancy;
  • can not follow-up.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telitacicept arm

Arm Description

Telitacicept 160mg once a week for 24 week as an add-on treatment regimen.

Outcomes

Primary Outcome Measures

new thrombotic event
any new thrombotic event during Telitacicept treatment

Secondary Outcome Measures

improvement of thrombocytopenia during Telitacicept treatment
elevated platelet counts
improvement of hemolytic anemia during Telitacicept treatment
elevated hemoglobin
improvement of aPL nephropathy during Telitacicept treatment
decrease of proteinuria or creatinine
improvement of valve heart disease during Telitacicept treatment
decrease of valve thickness or vegetation by echocardiogram
improvement of neurological manifestations during Telitacicept treatment
MRI improvement
decrease of aPL titer during Telitacicept treatment
titer change of lupus anticoagulant, anticardiolipin antibody and anti-β2 glycoprotein-I antibody

Full Information

First Posted
September 24, 2021
Last Updated
October 12, 2021
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05078710
Brief Title
Telitacicept in Primary APS Patients
Official Title
A Pilot Study of Telitacicept Treatment in Primary APS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single-arm pilot study in Peking Union Medical College Hospital. Telitacicept will be added on traditional antithrombotic and immunosuppressive treatment in primary antiphospholipid syndrome (APS) patients with three positive antiphospholipid antibodies (aPL) and at least one extra-criteria manifestations, including thrombocytopenia, autoimmune hemolytic anemia, aPL associated nephropathy, heart valvular disease, non-stroke neurological manifestations. This study aims to evaluate the efficacy of Telitacicept in preventing thrombosis and improving extra-criteria manifestations on high-risk APS patients.
Detailed Description
The study started on July 2021 and will last 1.5 years. Primary APS patients with three positive aPL and extra-criteria manifestations with be enrolled. This is a single-arm pilot study. Telitacicept 160mg once a week for 24 weeks will be added on traditional antithrombotic and immunosuppressive treatment. Patients will be followed on week 12 and week 24. The primary endpoint is new thrombotic event. The secondary endpoints are improvement of extra-criteria manifestations, and titer change of aPL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti Phospholipid Syndrome
Keywords
anti phospholipid syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telitacicept arm
Arm Type
Experimental
Arm Description
Telitacicept 160mg once a week for 24 week as an add-on treatment regimen.
Intervention Type
Drug
Intervention Name(s)
Telitacicept
Other Intervention Name(s)
traditional antithrombotic and immunosuppressive treatment
Intervention Description
160mg once a week for 24 weeks
Primary Outcome Measure Information:
Title
new thrombotic event
Description
any new thrombotic event during Telitacicept treatment
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
improvement of thrombocytopenia during Telitacicept treatment
Description
elevated platelet counts
Time Frame
24 weeks
Title
improvement of hemolytic anemia during Telitacicept treatment
Description
elevated hemoglobin
Time Frame
24 weeks
Title
improvement of aPL nephropathy during Telitacicept treatment
Description
decrease of proteinuria or creatinine
Time Frame
24 weeks
Title
improvement of valve heart disease during Telitacicept treatment
Description
decrease of valve thickness or vegetation by echocardiogram
Time Frame
24 weeks
Title
improvement of neurological manifestations during Telitacicept treatment
Description
MRI improvement
Time Frame
24 weeks
Title
decrease of aPL titer during Telitacicept treatment
Description
titer change of lupus anticoagulant, anticardiolipin antibody and anti-β2 glycoprotein-I antibody
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: meet 2006 Sapporo classification criteria of APS; diagnosis of primary APS, exclude other etiologies of thrombosis; with three aPL medium-to-high titer positivity, namely lupus anticoagulant, anti cardiolipin antibody, and anti-β2 glycoprotein antibody; with at least one extra-criteria manifestations of APS, including thrombocytopenia, hemolytic anemia, aPL nephropathy, valve heart disease and neurological manifestations. Exclusion Criteria: overlap with other connective tissue diseases, such as systemic lupus erythematosus; during pregnancy; can not follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiuliang Zhao, M.D.
Phone
0086-13810103105
Email
Jiuliang.zhao@cstar.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Can Huang, M.D.
Phone
0086-13426191948
Email
huang_can@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiuliang Zhao, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiuliang Zhao, M.D.
Phone
0086-13810103105
Email
Jiuliang.zhao@cstar.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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