PACTR201912487382180已完成未知
Azathioprine use in remission of patients with severe Graves' Disease
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 163
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- All
入选标准
- •a.Aged 18-75 years.
- •b.Interested and willing to participate in the study.
- •c.newly diagnosed Graves' disease with severe hyperthyroidism and do not be treated with anti-thyroid medications.
- •Severe hyperthyroidism was defined in patients who have one or more of the following items:
- •Those who are extremely symptomatic especially with heart rate?>?120 b/min, got hyperthyroid heart disease, or loss of weight?>?10?kg,
- •patients who have free T4 or free T3 estimates 2–3 times the upper limit of normal. (FT4 = 3.6 ng/dL,or FT3 = 8.4 pg/mL, respectively)
- •d.If a female in the childbearing period must:
- •i.neither be pregnant nor breastfeeding nor attempting to conceive.
- •ii.use a highly effective method of contraception throughout the entire duration of the study and for at least 90 days after the last dose of azathioprine.
- •iii.A serum pregnancy test will be performed at the first screening visit.
排除标准
- •a-End stage diseases.
- •b-Live vaccines within the past 3 months
- •c-Haemoglobin concentration < 12 g/dl ; platelet count < 130 × 109/L. White cell count below the local laboratory's reference range; Lymphocyte count < 0.8 × 109/L
- •d-Known history of active or chronic infectious disease or any disease which compromises immune function (e.g. HIV+, HTLV-1, Latent or active TB, Hepatitis).
- •e-A known history of hypersensitivity reactions to Aza.
- •f-Signs of moderate or severe orbitopathy including optic nerve compression requiring steroids and/or a clinical activity score >3.
- •g-Treatment with steroids (administered via the oral and/or parenteral routes) or adrenocorticotropic hormone with the exception of inhaled steroids within the three months prior to Study Day 1.
- •h-Patients require urgent treatment of thyrotoxicosis.
- •i.Significant cardiac disease and/or atrial fibrillation
- •ii.Symptoms and signs of thyroid storm.
- •iii.Large and compressive goiters causing localized symptoms such as difficulty swallowing or breathing
- •i-The use of azathioprine, or participation in any Clinical Trial within three months prior to Study Day 1.
- •j-Treatment with any cytokine or anti-cytokine therapy within three months prior to Study Day 1.
- •k-Inadequate liver function, defined by total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase
- •(ALT) or alkaline phosphatase > 3 times the upper limit of the normal values at the screening visit.
- •l-Subject with any significant medical illness or psychiatric condition would preclude participation in the study or impair the ability to give informed consent; any other clinically apparent autoimmune disease.
- •M- pregnant or lactating females. Also, females attempting to conceive will be excluded
研究者
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