The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Teriflunomide, Dexamethasone.
- Who it may be relevant to
- Registry conditions: Immune Thrombocytopenia (ITP). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Teriflunomide and High-dose Dexamethasone vs High-dose Dexamethasone Alone as First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial
Overview
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).
Detailed description
The investigators are undertaking a parallel-group, multicenter, randomized controlled trial of 132 adults with ITP in China. Patients were randomized to teriflunomide plus high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding, and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Interventions
- Drug Teriflunomide
Teriflunomide 14 mg orally once daily for 24 weeks. - Drug Dexamethasone
Dexamethasone 40 mg orally once daily for four consecutive days.
Primary outcome measures
- Sustained response [Time frame: Week 24]
Secondary outcome measures (6)
- Initial response [Time frame: Week 4]
- Time to response [Time frame: Week 24]
- Duration of response [Time frame: Week 24]
- Bleeding events [Time frame: Week 24]
- Adverse events [Time frame: Week 24]
- Health-related quality of life (HRQoL) [Time frame: Week 24]
Eligibility criteria
Inclusion criteria
- Patients aged ≥18 years;
- Newly diagnosed, treatment naïve ITP patients;
- Patients with a platelet count <30 x10\^9/L or a platelet count <50 x10\^9/L with bleeding manifestations at the enrollment;
- Willing and able to sign written informed consent.
Exclusion criteria
- Secondary ITP such as drug-related thrombocytopenia, viral infection (HIV, hepatitis B virus, or hepatitis C virus);
- Pre-existing acute or chronic liver disease, or ALT/AST greater than 2 times the upper limit of normal (ULN);
- Severe cardiac, renal, hepatic, or respiratory insufficiency;
- Severe immunodeficiency;
- Pregnancy or lactation;
- Active or a history of malignancy;
- Active infection requiring systemic therapy;
- Myelodysplastic syndrome, aplastic anemia, or myelofibrosis;
- A known diagnosis of other autoimmune diseases;
- Patients who are deemed unsuitable for the study by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Peking University First Hospital — Beijing
- Peking University Insititute of Hematology, Peking University People's Hospital — Beijing
- Peking University Third Hospital — Beijing
Identifiers
NCT: NCT07065968 · TY2025006