Actively Recruiting
Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia
Led by Beijing Hospital · Updated on 2025-05-06
296
Participants Needed
23
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
Beijing Hospital
Lead Sponsor
T
The First Affiliated Hospital of Anhui Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with connective tissue disease-associated thrombocytopenia, including primary Sjögren syndrome, systemic lupus erythematosus, or undifferentiated connective tissue disease
- Refractory thrombocytopenia defined as failure to maintain remission after glucocorticoid and immunosuppressant treatment or relapse during glucocorticoid tapering or withdrawal
- Platelet count greater than 50 x 10^9/L
- Positive anti-nuclear antibody (ANA) test with a titer of at least 1:80
- Stable standard therapy including glucocorticoids, hydroxychloroquine, or immunosuppressants for at least 14 days prior to first dose
- Signed informed consent and able to participate in all study procedures
You will not qualify if you...
- Vital organ or intracranial bleeding at screening or within 6 months prior
- Antiphospholipid syndrome, thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, or other secondary thrombocytopenia causes
- Blood disorders such as myelodysplastic syndrome, aplastic anemia, leukemia, lymphoma, or myelofibrosis
- Severe cardiovascular diseases including unstable angina, heart failure, uncontrolled hypertension, or arrhythmia
- History of arteriovenous thromboembolism
- Receiving antiplatelet or anticoagulant therapy at screening
- Significant ECG changes or prolonged QT interval
- Severe pulmonary diseases affecting respiratory function
- Severe kidney disease including severe lupus nephritis or renal insufficiency requiring dialysis
- Central nervous system diseases including epilepsy, psychosis, or stroke within 8 weeks
- Active hepatitis or severe liver disease; positive hepatitis B or C markers with active infection
- Abnormal liver enzymes or low white blood cell count
- Known active infections including shingles, COVID-19, HIV, tuberculosis, or gastrointestinal ulcers
- Pregnant or breastfeeding women
- History of allergic reactions to human biological products
- Recent treatment with B cell-targeting agents, TNF inhibitors, or live vaccines within specified timeframes
- Unstable dosage of thrombopoietin receptor agonists within 14 days
- History of depression or suicidal thoughts
- Previous treatment with telitacicept
- Intolerance or lack of response to B cell targeting therapy
- Investigator's judgment deeming participant unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
The First Affiliated Hospital of Anhui Medical College
Hefei, Anhui, China, 230022
Actively Recruiting
2
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
Hefei, Anhui, China
Actively Recruiting
3
Beijing Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
4
Peking University People's Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
5
Peking University Third Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
6
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Actively Recruiting
7
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
8
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
9
Wuhan Union Hospital, China
Wuhan, Hubei, China
Actively Recruiting
10
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
11
Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
12
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Actively Recruiting
13
First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
14
Shandong Provincial Hospital
Jinan, Shandong, China
Actively Recruiting
15
Changhai Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
16
RenJi Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
17
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Actively Recruiting
18
West China Hospital
Chengdu, Sichuan, China
Actively Recruiting
19
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
20
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
21
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
22
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang Uygur Autonomous Region, China
Actively Recruiting
23
The First People's Hospital of Yunnan
Kunming, Yunnan, China
Actively Recruiting
Research Team
X
Xuan Zhang, MD.
CONTACT
Y
Yongjing Cheng, MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here