NCT04837703Available不适用
Managed Access Programs for ETB115, Eltrombopag
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
研究概览
简要总结
The purpose of this registration is to list Managed Access Programs (MAPs) related to ETB115, Eltrombopag
详细描述
CETB115B2003I - Available - Managed Access:Treatment Plan: Individual Patient Program of Eltrombopag for Treatment of Patients with medically significant thrombocytopenia
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
- •The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
- •There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
- •The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
- •Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
- •Managed Access provision is allowed per local laws/regulations.
排除标准
- •Patients eligible for this Treatment Plan must not meet any of the following criteria:
- •Presence of moderate to severe impaired renal function as indicated by any or all of the following criteria:
- •Creatinine clearance < 45 mL/min as calculated using Cockcroft-Gault formula
- •Serum creatinine > 1.5 mg/dL
- •Total bilirubin > 1.5 × upper limit of normal (ULN)
- •Aspartate transaminase (AST) > 3.0 × ULN
- •Alanine transaminase (ALT) > 3.0 × ULN
- •Patient with liver cirrhosis.
- •Infection not adequately controlled with appropriate therapy.
- •Patients who are human immune deficiency virus (HIV), hepatitis C virus or hepatitis B surface antigen (HBsAg) positive. HCV-RNA negative patients are allowed to be enrolled.
- •Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to consent, be compliant with study procedures, tolerate protocol therapy, or patients with less than 3 months of life expectancy.
- •History of hypersensitivity to eltrombopag or to any of the excipients in eltrombopag
- •Patients with any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), AND ≥ two of the following risk factors: hormone replacement therapy, systemic contraception (containing oestrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, etc), or any other family history of arterial or venous thrombosis.
- •Patients with concurrent malignant disease.
- •Patients with SLE, antiphospholipid antibody syndrome or chronic hepatitis B infection,
- •Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the treatment guidelines.
- •Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of program treatment.
- •History of non-compliance with medical regimens or patients who are considered potentially unreliable and/or not cooperative, unwilling or unable to comply with the treatment guidelines.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, (or female partners of male patients) unless they are using highly effective methods of contraception while taking study treatment and for 3 months after stopping medication. Highly effective methods of contraception methods include:
- •Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
- •Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
- •Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient
- •Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example, hormone vaginal ring or transdermal hormone contraception..
- •In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
- •Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks in advance. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- •Sexually active males must be willing to use a condom during intercourse while taking study treatment and for 3 months after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above.
- •If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent form (ICF).
- •No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
研究者
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