EUCTR2008-002113-48-FR进行中（未招募）1 期
A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 99
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female = 18 years.
- •2. Clinically definite diagnosis of tuberous sclerosis according to the modified Gomez criteria (Roach et al, 1998; Hyman and Whittemore, 2000) or sporadic LAM (biopsy-proven or compatible chest CT).
- •3. Clinically definite diagnosis of renal angiomyolipoma.
- •4. Presence of at least one angiomyolipoma = 3 cm in its longest diameter using MRI.
- •5. If female and of child bearing potential, documentation of negative pregnancy test prior to enrollment. Sexually active pre-menopausal female patients (and female partners of male patients) must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study.
- •6. Written informed consent. Parents or legal guardians must sign the informed consent for patients with developmental delays.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Angiomyolipoma-related bleeding or embolization during the 6 months prior to randomization.
- •2. History of myocardial infarction, angina or stroke related to atherosclerosis.
- •3. Impaired lung function, defined as any of the following:
- •FEV1 = 70% of predicted, or
- •DLCO = 70% of predicted, or
- •= 88% O2 saturation at rest in room air.
- •4. Chylous ascites sufficient to affect diaphragmatic function or pulmonary function testing.
- •5. Significant hematological or hepatic abnormality (i.e., transaminase levels > 2.5 × the upper limit of normal (ULN), serum bilirubin > 1.5 × ULN, hemoglobin < 9g/dL, platelets < 80,000/mm3, or absolute neutrophil count < 1,000/mm3).
- •6. Pregnancy or breast feeding.
- •7. Use of estrogen containing medications.
- •8. Intercurrent infection at date of randomization.
- •9. Prior history of organ transplant.
- •10. Recent surgery (involving entry into a body cavity or requiring sutures) within the 2 months prior to randomization.
- •11. Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus).
- •12. Use of an investigational drug within the 30 days prior to randomization.
- •13. Uncontrolled hyperlipidemia: Fasting serum cholesterol > 300 mg/dL OR > 7.75 mmol/L AND Fasting triglycerides > 2.5 × ULN.
- •14. Uncontrolled diabetes mellitus as defined by fasting serum glucose > 1.5 × ULN.
- •15. Patients with bleeding diathesis or on oral anti-vitamin K medication (except low dose warfarin).
- •16. Patients with a known history of HIV seropositivity.
- •17. Inability to attend scheduled clinic visits.
- •18. For the purpose of MRI assessments:
- •Ferromagnetic metal implants other than those approved as safe for use in MR scanner (e.g., braces, some types of aneurysm clips, shrapnel).
- •Patients suffering from uncontrollable claustrophobia or physically unable to fit into the machine (e.g., obesity, etc).
- •19. Serum creatinine > 1.5 × ULN.
- •20. History of malignancy in the past two years, other than squamous or basal cell skin cancer.
研究者
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