Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Hospital
About this trial
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 criteria
Qualifiers
Subjects who have been diagnosed with connective tissue disease (CTD)-associated thrombocytopenia. And CTD includes primary Sjögren syndrome (according to the 2002 American College of Rheumatology (ACR)/ European League against Rheumatism (EULAR) classification criteria), systemic lupus erythematosus (SLE, according to the 1997 or the 2009 ACR classification criteria), and undifferentiated connective tissue disease (according to the 1999 international classification criteria)
50×10^9/L>PLT
anti-nuclear antibody (ANA) positive (≥1:80, any karyotype) detected in the laboratory of each research center
Standard therapy should be maintained stable for at least 14 days prior to the first dose of the experimental drug or placebo. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.)
Disqualifiers
Vital organ lethal bleeding (including but not limited to central nervous system bleeding, digestive tract bleeding) at screening, or intracranial bleeding 6 months prior to screening
Antiphospholipid syndrome, thrombotic thrombocytopenia purpura, hemolytic uremic syndrome, or thrombocytopenia secondary to other causes (such as sepsis, Epstein-Barr virus infection, cytomegalovirus infection, Corona Virus Disease-19 (COVID-19) infection, drugs, etc.)
Hematopoietic system disorders, such as myelodysplastic syndrome, paroxysmal sleep hemoglobinuria, aplastic anemia, leukemia, lymphoma, myelofibrosis and so on
Severe cardiovascular system disease, including: unstable or uncontrollable disease or condition affecting the function of the heart (such as angina pectoris, congestive heart failure, uncontrolled hypertension or arrhythmia)
Trial design
Treatments tested in this trial
- Telitacicept
- Placebo
Treatment groups
296 Participants
are divided into 2 treatment groupsSponsors and collaborators
Beijing Hospital
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Collaborator
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
Collaborator
Peking University People's Hospital
Collaborator
Peking University Third Hospital
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Guangdong Provincial People's Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
Xiangya Hospital of Central South University
Collaborator
The Affiliated Hospital of Inner Mongolia Medical University
Collaborator
First Hospital of China Medical University
Collaborator
Shandong Provincial Hospital
Collaborator
Changhai Hospital
Collaborator
RenJi Hospital
Collaborator
Shanxi Bethune Hospital
Collaborator
West China Hospital
Collaborator
Institute of Hematology & Blood Diseases Hospital, China
Collaborator
Tianjin First Central Hospital
Collaborator
Tianjin Medical University General Hospital
Collaborator
People's Hospital of Xinjiang Uygur Autonomous Region
Collaborator
The First People's Hospital of Yunnan
Collaborator
Source ClinicalTrials.gov