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RecruitingPhase 2NCT05998759

Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia

A Randomized, Double-blind Placebo-controlled Study of Recombinant Human B Lymphocyte Stimulating Factor Receptor-Fc Fusion Protein for the Treatment of Connective Tissue Disease-associated Thrombocytopenia

Sponsor

Beijing Hospital

Enrollment

296 participants

Start Date

Dec 2, 2023

Study Type

INTERVENTIONAL

Conditions

ThrombocytopeniaConnective Tissue Diseases

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of Telitacicept for the treatment of connective tissue disease-associated thrombocytopenia.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called telitacicept in patients who have an autoimmune connective tissue disease (such as lupus or Sjögren's syndrome) that has caused a dangerously low platelet count (thrombocytopenia) that hasn't improved with standard treatments. **You may be eligible if...** - You have been diagnosed with a connective tissue disease such as lupus (SLE), primary Sjögren's syndrome, or undifferentiated connective tissue disease - Your platelet count is persistently low despite treatment with steroids and at least one other immune-suppressing medication - You have not responded to, or cannot tolerate, standard treatments for low platelets **You may NOT be eligible if...** - Your low platelet count is well-controlled with current medications - You have not yet tried standard immunosuppressant treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTelitacicept

subcutaneous telitacicept 160 mg weekly for 24 weeks.

DRUGPlacebo

subcutaneous placebo weekly for 24 weeks.

Locations(23)

The First Affiliated Hospital of Anhui Medical College

Hefei, Anhui, China

The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)

Hefei, Anhui, China

Beijing Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Wuhan Union Hospital, China

Wuhan, Hubei, China

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

First Hospital of China Medical University

Shenyang, Liaoning, China

Shandong Provincial Hospital

Jinan, Shandong, China

Changhai Hospital

Shanghai, Shanghai Municipality, China

RenJi Hospital

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

West China Hospital

Chengdu, Sichuan, China

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang Uygur Autonomous Region, China

The First People's Hospital of Yunnan

Kunming, Yunnan, China

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NCT05998759

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