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Telitacicept in Primary APS Patients

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ClinicalTrials.gov Identifier: NCT05078710
Recruitment Status : Recruiting
First Posted : October 14, 2021
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anti Phospholipid Syndrome Drug: Telitacicept Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Telitacicept Treatment in Primary APS Patients
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Telitacicept arm
Telitacicept 160mg once a week for 24 week as an add-on treatment regimen.
 Drug: Telitacicept
160mg once a week for 24 weeks
Other Name: traditional antithrombotic and immunosuppressive treatment


Outcome Measures
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Primary Outcome Measures :
  1. new thrombotic event [ Time Frame: 24 weeks ]
    any new thrombotic event during Telitacicept treatment


Secondary Outcome Measures :
  1. improvement of thrombocytopenia during Telitacicept treatment [ Time Frame: 24 weeks ]
    elevated platelet counts

  2. improvement of hemolytic anemia during Telitacicept treatment [ Time Frame: 24 weeks ]
    elevated hemoglobin

  3. improvement of aPL nephropathy during Telitacicept treatment [ Time Frame: 24 weeks ]
    decrease of proteinuria or creatinine

  4. improvement of valve heart disease during Telitacicept treatment [ Time Frame: 24 weeks ]
    decrease of valve thickness or vegetation by echocardiogram

  5. improvement of neurological manifestations during Telitacicept treatment [ Time Frame: 24 weeks ]
    MRI improvement

  6. decrease of aPL titer during Telitacicept treatment [ Time Frame: 24 weeks ]
    titer change of lupus anticoagulant, anticardiolipin antibody and anti-β2 glycoprotein-I antibody


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05078710


Contacts
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Contact: Jiuliang Zhao, M.D. 0086-13810103105 Jiuliang.zhao@cstar.org.cn
Contact: Can Huang, M.D. 0086-13426191948 huang_can@yeah.net

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Jiuliang Zhao, M.D.    0086-13810103105    Jiuliang.zhao@cstar.org.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Jiuliang Zhao, M.D. Peking Union Medical College Hospital
More Information
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT05078710    
Other Study ID Numbers: PUMCH-ZS-3026
First Posted: October 14, 2021    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
anti phospholipid syndrome
Additional relevant MeSH terms:
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Antiphospholipid Syndrome
Autoimmune Diseases
Immune System Diseases
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs