Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia

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.

Conditions

• Connective Tissue Diseases
• Thrombocytopenia

Interventions

BIOLOGICAL

Telitacicept

subcutaneous telitacicept 160 mg weekly for 24 weeks.

DRUG

Placebo

subcutaneous placebo weekly for 24 weeks.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

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

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• The Affiliated Hospital of Inner Mongolia Medical University

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Changhai Hospital

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Shanxi Bethune Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Institute of Hematology & Blood Diseases Hospital, China

  collaborator OTHER

• Tianjin First Central Hospital

  collaborator OTHER

• Tianjin Medical University General Hospital

  collaborator OTHER

• People's Hospital of Xinjiang Uygur Autonomous Region

  collaborator OTHER

• The First People's Hospital of Yunnan

  collaborator OTHER

• Beijing Hospital

  lead OTHER_GOV

Principal Investigators

• Xuan Zhang, MD. · Beijing Hospital

• Yongjing Cheng, MD. · Beijing Hospital

• Shengqian Xu, MD. · The First Affiliated Hospital of Anhui Medical Hospital

• Zhu Chen, MD. · The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)

• Jing He, MD. · Peking University People's Hospital

• Rong Mu, MD. · Peking University Third Hospital

• Niansheng Yang, MD. · First Affiliated Hospital, Sun Yat-Sen University

• Yang Li, MD. · Guangdong Provincial People's Hospital

• Guanmin Gao, MD. · The First Affiliated Hospital of Zhengzhou University

• Anbin Huang, MD. · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

• Fen Li, MD. · Second Xiangya Hospital of Central South University

• Hui Luo, MD. · Xiangya Hospital of Central South University

• Hongbin Li, MD. · The Affiliated Hospital of Inner Mongolia Medical University

• Pinting Yang, MD. · First Hospital of China Medical University

• Hongsheng Sun, MD. · Shandong Provincial Hospital

• Dongbao Zhao, MD. · Changhai Hospital

• Sheng Chen, MD. · RenJi Hospital

• Liyun Zhang, MD. · Shanxi Bethune Hospital

• Qibing Xie, MD. · West China Hospital

• Lei Zhang, MD. · Institute of Hematology & Blood Diseases Hospital, China

• Wufang Qi, MD. · Tianjin First Central Hospital

• Wei Wei, MD. · Tianjin Medical University General Hospital

• Lijun Wu, MD. · People's Hospital of Xinjiang Uygur Autonomous Region

• Qin Li, MD. · The First People's Hospital of Yunnan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-02

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• China

Study Locations