EUCTR2016-000624-25-IT进行中（未招募）1 期
An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Biological Activity of ATYR1940 in Patients with Limb Girdle and Fascioscapulohumeral Muscular Dystrophy - na
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 8
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. Enrolled in and completed the treatment period in the parent study.
- •2. Demonstrated, in the Investigator’s opinion, acceptable tolerability of ATYR1940.
- •3. In the Investigator’s opinion, patient has shown acceptable compliance with ATYR1940 and the study procedures in the parent study and is willing and able to comply with all procedures in the current study.
- •4. Is, in the Investigator’s and Sponsor’s opinion, a suitable candidate for continued ATYR1940 treatment.
- •5. Provide written informed consent after the nature of the study has been explained and prior to the performance of any research-related procedures.
- •Are the trial subjects under 18? yes
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. At any time during participation in the parent study, met a ATYR1940 discontinuation criterion, including, but not limited to:
- •- Jo-1 antibody (Ab) levels =1.5 U/mL.
- •- Clinical evidence of a generalized infusion-related reaction (IRR).
- •- Clinical evidence of a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.03) =Grade 2, study-drug-related serious adverse event (SAE).
- •- Pregnancy.
- •- Progression of disease that, in the opinion of the Investigator, precluded further participation in the study.
- •- Withdrawal of consent.
- •- Other findings that, at the discretion of the Investigator and/or Sponsor, indicated that study drug administration should be discontinued.
- •2. Is expected to require treatment with curcumin or systemic albuterol (intermittent inhaled albuterol is permissible) during study participation; or use of a product that putatively enhances muscle growth (e.g., insulin-like growth factor, growth hormone) or activity (e.g., Coenzyme Q, Coenzyme A, creatine, L-carnitine) on a chronic basis; or statin treatment initiation or significant adjustment to statin regimen (stable, chronic statin use is permissible).
- •3. Patient planned to receive any vaccination during study participation.
- •4. Abnormal baseline findings, medical condition(s), or laboratory findings that, in the Investigator’s opinion, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •5. Evidence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, metabolic, dermatological, or gastrointestinal disease, or has a condition that requires immediate surgical intervention or other treatment or may not allow safe participation.
- •6. If female and of childbearing potential (premenopausal and not surgically sterile), has a positive pregnancy test at entry or is unwilling to use contraception from the time of entry through the 3-month Follow-up visit. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra-uterine device.
- •7. If male, is unwilling to use a condom plus spermicide during sexual intercourse from the time of entry through the 1 month Follow-up visit.
研究者
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