EUCTR2017-002713-58-IT进行中（未招募）1 期
Multicenter, Safety and Efficacy, Open-Label Extension Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects with Thyroid Eye Disease - OPTIC-X
HORIZON PHARMA USA, INC.0 个研究点目标入组 50 人开始时间: 2019年1月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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. Written informed consent.
- •2. Completed the 24-week double-maskedTreatment Period in Study HZNP-TEP-301.
- •3. Proptosis non-responder (< 2 mm reduction in proptosis in the study eye) at Week 24 ofStudy HZNP-TEP-301 OR proptosis responder at Week 24 who relapses (see Section 9.3.4)during the Follow-Up Period of Study HZNP-TEP-301.
- •4. Subject must be euthyroid with the baseline disease under control, or have mild hypo- or hyperthyroidism (defined as free thyroxine [FT4] and free triiodothyronine [FT3] levels < 50% above or below the normal limits) at the most recent clinic visit.Every effort should be made to correct the mild hypo-or hyperthyroidism promptly and to maintain the euthyroid state for the full duration of the clinical trial.
- •5. Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) =3 times the upper limit of normal (ULN) or serum creatinine <1.5 times the ULN (according to age) at the most recent clinic visit.
- •6. Diabetic subjects must have well-controlled disease (defined as HgbA1c < 9.0%at most recent clinic visit).
- •7. Does not require immediate surgical ophthalmological interventionand is not planning corrective surgery/irradiation during the course of the study.
- •8. Women of childbearing potentialmust have a negative urine pregnancy testat Baseline/Day 1and agree to use 2 reliable forms of contraception during the trialand continue for 180 days after the last dose of study drug.One of the 2 forms of contraceptionis recommended to be hormonal, such as an oral contraceptive.Hormonal contraception must be in use for at least one full cycle prior to Baseline. Highly effective contraceptive methods (with a failure rate less than 1% per year), when used consistently and correctly, includes implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner.
- •9. Male subjects must be surgically sterile or must agree to use a barrier contraceptive method from Baseline through 180days after the last dose of study drug.
- •10. Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.
- •11. Has not received any treatment for TED since Week 24 of the HZNP-TEP-301 study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Subjects will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the study protocol or have a concomitant disease or condition that could interfere with the conduct of the study or potentially put the subject at unacceptable risk.
研究者
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