NCT03038633已完成1 期
A Trial to Evaluate the Safety and Tolerability of a Novel Medical Food for Management of Iron Deficiency Anemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Dose-limiting toxicity, (DLT)
研究概览
简要总结
This is a Phase 1 clinical trial designed to evaluate the safety and tolerability of a novel medical food utilizing a nutritional strain of yeast for management of Iron Deficiency Anemia.
详细描述
The investigational product is a medical food and is the result of discoveries following extensive research on two preclinical models carried out by a team of researchers at Penn State University. This study will utilize the standard "3+3" rule-based dose-escalation schemes, which use predetermined dose levels and cohorts of three patients. The total time commitment for each subject is approximately three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemoglobin, (Hgb) 7-10 g/dL; transferrin saturation <20%; and serum ferritin <20ng/mL
排除标准
- •Pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception (tubal ligation or otherwise be incapable of pregnancy, hormonal contraceptives, spermicide plus barrier or intrauterine device).
- •Present consumption of iron supplements or multivitamins must be switched to vitamins not containing iron, such as the multivitamin Centrum Silver. No washout period is necessary since it will be apparent from the ongoing anemia that any current supplements are ineffective.
- •Current anemia not attributed to immune deficiency, (ID) (e.g. other microcytic anemia or hemolytic, macrocytic, sideroblastic or myelosuppression or chemotherapy or radiotherapy induced anemia).
- •Active malignancy within 1 year. Basal or squamous cell skin cancer is not exclusionary.
- •Aspartate Aminotransferase, (AST) or Alanine Aminotransferase, (ALT) at screening greater than 1.5 times the upper limit of normal.
- •Known positive hepatitis B with evidence of active hepatitis.
- •Known positive HIV-1/HIV-2 antibodies (anti-HIV).
- •Patient has a current diagnosis of asthma and is actively using an anti-asthmatic therapy.
- •Received an investigational drug within 30 days of screening.
- •Hemochromatosis or other iron storage disorders.
- •Unregulated hypertension
- •Chronic kidney disease.
- •Chronic inflammatory condition including but not limited to Lupus and Rheumatoid Arthritis.
- •Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of New York Heart Association, (NYHA) Class III or IV congestive heart failure.
- •Irritable Bowel Syndrome
- •Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator puts the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
- •Breastfeeding planned on or after enrolling in the study.
- •Known allergy to yeast
- •Currently on Monoamine oxidase inhibitors, (MAOI's) or Demerol
结局指标
主要结局
Dose-limiting toxicity, (DLT)
时间窗: 28 Days
Still evaluating data
次要结局
未报告次要终点
研究者
Jeffrey J. Pu, MD, PhD
Assistant Proffesor of Medicine
Milton S. Hershey Medical Center
研究点 (2)
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