Actively Recruiting
The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)
Led by Peking University People's Hospital · Updated on 2025-09-08
132
Participants Needed
3
Research Sites
123 weeks
Total Duration
On this page
Sponsors
P
Peking University People's Hospital
Lead Sponsor
P
Peking University Health Science Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
A multicenter, open-label, randomized study to report the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).
CONDITIONS
Official Title
The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Newly diagnosed, treatment-naive primary immune thrombocytopenia (ITP) patients
- Platelet count less than 30 x10^9/L or less than 50 x10^9/L with bleeding symptoms at enrollment
- Willing and able to sign written informed consent
You will not qualify if you...
- Secondary ITP such as drug-related thrombocytopenia or viral infection (HIV, hepatitis B, or hepatitis C)
- Pre-existing acute or chronic liver disease or ALT/AST values over twice the upper limit of normal
- Severe heart, kidney, liver, or lung failure
- Severe immune system deficiency
- Pregnancy or breastfeeding
- Active cancer or history of cancer
- Active infections needing systemic treatment
- Blood disorders such as myelodysplastic syndrome, aplastic anemia, or myelofibrosis
- Known diagnosis of other autoimmune diseases
- Patients considered unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
X
Xiao-Hui Zhang, MD
CONTACT
L
Li-Ping Yang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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