NCT04807309撤回1 期
PRETELL: PREvention of TELomere-related Complications After Lung Transplant
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
To evaluate the safety and efficacy of Danzol in lung transplant recipients with short telomeres.
Subjects with short telomeres recipient of lung transplant, will be randomized in the first month post-transplant to either placebo or Danazol (200mg bid) in a 2:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Similar tablets will be generated.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18
- •Ability to give informed consent
- •Recipient of lung transplantation
- •Short telomeres assessed either pre-transplant or post-transplant with FLOW-FISH as lymphocyte telomere length <10th percentile predicted for age
- •Clinically stable one month after lung transplant
排除标准
- •Patients on androgen hormones to include testosterone or high dose estrogen (estradiol 0.5 mg/day or greater) during 12 months prior to enrollment
- •Patients with active thrombosis or thromboembolic disease and history of such events unless thrombosis is line related.
- •Undiagnosed abnormal genital bleeding, porphyria, androgen-dependent tumor, or prostatic hypertrophy
- •Patients with active hepatitis B or C
- •Patients who have received a bone marrow transplant
- •Clinically unstable after lung transplantation
- •Current pregnancy, or unwillingness to take be on two forms of contraceptives including a barrier method of birth control or practice abstinence to refrain from pregnancy if of childbearing potential during the course of the study
- •Lactating women, due to the potentially harmful effects on the nursing child
- •Patients with abnormal liver function AST, ALT >3 times normal
- •Subjects with a history of benign intracranial hypertension
- •Subjects with a history of liver disease not limited to alcoholic hepatitis/cirrhosis, non-alcoholic steatohepatitis (NASH), autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), and/or history of hepatic adenoma.
- •Subjects with poorly controlled or uncontrolled Type I or II diabetes mellitus
- •Significant renal abnormalities GFR< 40 ml/min/m2
- •Significant cardiac dysfunction with ejection fraction less than 50%
- •Moribund status such as death is expected in the coming year
- •Currently taking carbamazepine, pimozide or lomitapide
- •Inability to understand the investigational nature of the study or to give informed consent
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo comparison
干预措施: Placebo (Drug)
Danazol Pill
Active Comparator
Danazol 200mg orally twice a day
干预措施: Danazol Pill (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 48 weeks
The incidence, severity, outcome, and relationship to study treatment of adverse events and serious adverse events. Change from baseline in clinical laboratory test results.
次要结局
- Occurrence of WBC <2000/µl(48 weeks)
- Cumulative number of events where WBC < 2000/µl(48 weeks)
研究者
Souheil El-Chemaly, MD, MPH
Associate Physician
Brigham and Women's Hospital
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