A randomized, open-label, multicenter study to compare 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).
This is 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. Patients who do not respond to dexamethasone may receive another cycle of high-dose dexamethasone therapy within 2 weeks. Platelet count, bleeding, and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Teriflunomide 7 mg orally once daily for 24 weeks. Dose adjustments were made throughout the study based on individual platelet counts.
Dexamethasone 40 mg orally once daily for four consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 14).
Beijing Friendship Hospital
Beijing, China
Beijing Hospital
Beijing, China
Beijing Luhe Hospital
Beijing, China
Beijing Tsinghua Changgeng Hospital
Beijing, China
Sustained response
Platelet count over 30,000/μL and at least a 2-fold increase of the baseline count in the absence of bleeding and rescue therapy for at least four of the six visits between weeks 19 and 24.
Time frame: From the start of study treatment (Day 1) to the end of week 24
Overall response
Complete response (CR) was defined as platelet count over 100,000/μL and absence of bleeding. Response (R) was defined as platelet count over 30,000/μL and at least a 2-fold increase of the baseline count and absence of bleeding.
Time frame: From the start of study treatment (Day 1) to the end of week 24
Time to response
The time from treatment initiation to achieve a CR or a R.
Time frame: From the start of study treatment (Day 1) to the end of week 24
Duration of response
The time from the achievement of a complete response or a partial response to the loss of response.
Time frame: From the start of study treatment (Day 1) to the end of week 24
Initial response
The number of participants with achievement of CR or R at 4 weeks.
Time frame: From the start of study treatment (Day 1) up to week 4 of treatment
Bleeding events
Clinically significant bleeding was assessed using the World Health Organization (WHO) bleeding scale.
Time frame: From the start of study treatment (Day 1) to the end of week 24
Adverse events
Adverse events (AEs) were reported and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
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China-Japan Friendship Hospital
Beijing, China
Chinese PLA General Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
The Sixth Medical Center of PLA General Hospital
Beijing, China
Time frame: From the start of study treatment (Day 1) to the end of follow-up
Health-related quality of life (HRQoL)
ITP-patient assessment questionnaire (ITP-PAQ) was used to assess the HRQoL before and after treatment.
Time frame: From the start of study treatment (Day 1) to the end of week 24