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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.
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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
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Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) |
18 Year(s) |
75 Year(s) |
Both |