2024-516403-16-00招募中3 期
Intravenous Immunoglobulin plus oral prednisone or high-dose dexamethasone, for adults with immune thrombocytopenia (ITP) with moderate and severe bleeding: a randomized, multicentre trial (IVIORDEX)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 272
- 试验地点
- 31
- 主要终点
- Time (in days) to achieve an initial response (R) within 5 days. - Initial response (R) will be defined according to international guidelines (5) as a platelet count ≥ 30x109/L with at least a doubling of the baseline value in the absence of new bleeding and absence of the use of any other ITP directed therapies (other than the one of the treatment arm)
研究概览
简要总结
To demonstrate the non-inferiority in term of short-term response of oral dexamethasone given at 40 mg on days 1 to 4 compared to IVIg given at 1g/kg on days 1 and 2 in combination with prednisone (1 mg/kg per day for 3 weeks) in adult patients with immune thrombocytopenia (ITP) with mild to severe bleeding manifestations.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years ≤ 80 years
- •Diagnosis of ITP whatever the duration of the disease (newly diagnosed or relapsed) according to the standard definition
- •Platelet count ≤ 20 x 109/L
- •Any cutaneous and/or any mucosal bleeding manifestations
- •Affiliated to a social security regime
- •Written consent from patient
排除标准
- •Symptomatic COVID-19 disease
- •Ongoing viral infection (uncontrolled HIV, Viral hepatitis, herpes, varicella, zona)
- •Uncontrolled diabetes (Acido-cetosis)
- •Psychotic state not yet controlled by treatment
- •Inability or refusal to understand or refusal to sign the informed consent from study participation
- •Persons deprived of their liberty by judicial or administrative decision
- •Persons under legal protection (guardianship, curatorship)
- •Pregnant or breastfeeding woman or ineffective contraception
- •Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants
- •Life-threatening bleeding defined as Intracranial hemorrhage and/or active organ bleeding (GI tract, urinary tract or menorrhagia with at least a 2 g/dl decrease of hemoglobin value from baseline).
- •Ongoing anticoagulation treatment (Therapeutic Low molecular weight heparins (LMWHs), direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs))
- •Previous non-response to IVIg or DEX
- •Treatment with prednisone (1 mg/kg per day) for more than 3 days
- •Any contraindications to the prescribed Ig IV or prednisone patent medicine and to Neofordex®
- •Ongoing severe infection
- •Severe Renal insufficiency (DFG < 45 ml.min.1.73m2)
- •Severe Cardiac insufficiency (FEVG < 30 %)
结局指标
主要结局
Time (in days) to achieve an initial response (R) within 5 days. - Initial response (R) will be defined according to international guidelines (5) as a platelet count ≥ 30x109/L with at least a doubling of the baseline value in the absence of new bleeding and absence of the use of any other ITP directed therapies (other than the one of the treatment arm)
Time (in days) to achieve an initial response (R) within 5 days. - Initial response (R) will be defined according to international guidelines (5) as a platelet count ≥ 30x109/L with at least a doubling of the baseline value in the absence of new bleeding and absence of the use of any other ITP directed therapies (other than the one of the treatment arm)
次要结局
- Time (in days) to achieve an initial complete response (CR) in both arms (defined by a platelet count > 100 x 109/L in the absence use of any other ITP directed therapies between Day 1 and Day 5) in the two arms.
- Duration in time (in days) of overall response from Day 1 to the end of the study (6 months) in the two arms.
- Proportion of early (before day 5) treatment switches across arms
- Number of new bleeding manifestations between Day 1 and Day 5 in two arms. Bleeding manifestations will be assessed the score reported by Khellaf et al. without taking into account the age of the patient.
- Rates of response (R) and complete response (CR) at 28 days, and 6 months in the two arms.
- Number of bleeding manifestations between Day 5 and Day 28 in the two arms.
- Number of days of hospitalization between Day 1 and Day 28 in the two arms.
- Number of adverse events in the two arms.
- Incremental (decremental) cost effectiveness ratio expressed in cost per responder at 6 months
- Comparison of the number of responders, and outcome at 6 months in patients with positive and negative anti-platelets antibodies in the two arms.
研究者
Pr Matthieu Mahévas
Scientific
Assistance Publique Hopitaux De Paris
研究点 (31)
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