EUCTR2018-002135-19-FR进行中（未招募）1 期
A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •Capable of providing informed consent, which must be obtained prior to any study-related procedures.
- •1. One of the following:
- •a. Those who demonstrated persistent (as confirmed by endoscopy) loss of response (no improvement approximately 6 to 8 weeks after meeting loss of response criteria) or
- •b. two Clinical Flares after an episode (as confirmed by endoscopy) of loss of response during the Maintenance Study.
- •c. Those who have completed the MaintenanceStudy (even if the subject
- •declined endoscopy during a clinical flare assessment during the
- •Maintenance Study of Protocol 0157) and have a confirmed clinical remission status (in remission or not in remission) with available results
- •2. During the study and for 7 days after receiving the last dose of the study drug, females of childbearing potential or men capable of fathering children must agree to use highly effective birth control measures (failure rate <1% when used consistently and correctly) or agree to abstain from sexual intercourse. Females of childbearing potential must test negative for pregnancy at Day 1.
- •3. All male subjects must agree to refrain from semen donation during the study and for 7 days after the last dose of study drug.
- •4. Must be able and willing to adhere to the study visit schedule and comply with other study requirements.
- •Are the trial subjects under 18? no
- •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 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Has current symptoms or signs suggestive of fulminant colitis, toxic megacolon, intestinal perforation
- •2. Has a high risk of requiring surgery for UC during the study
- •3. Has been diagnosed during Protocol 0157 with Crohn’s disease, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, indeterminate colitis, or the subject has a current or past diagnosis of a fistula or abdominal abscess
- •4. Has dysplasia that was not completely resected or high-grade
- •dysplasia detected during Protocol 0157 ; however, subjects with spontaneous (non-colitis-associated) adenomas with low grade dysplasia that have been completely resected are eligible
- •5. Taking any medications of exclusion as listed in the protocol currently or previously during Protocol 0157 Maintenance
- •6. Deemed by the investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety or tolerability of the study drug (eg, developed unstable or uncontrolled and clinically significant allergic (except for untreated,
- •asymptomatic, seasonal allergies), hematological, endocrine/metabolic,
- •coagulation, immunologic, pulmonary, cardiovascular, hepatic (except
- •hepatic steatohepatitis), GI (except UC), genitourinary, psychiatric,
- •oncologic thrombotic (e.g., deep vein thromboses (DVT) or pulmonary
- •embolism or neurological disease or other medical disorder before,
- •during or after Protocol 0157]; or is unable or unwilling to comply with
- •the study protocol.
- •7. Develops hypersensitivity to excipients or contents of the study drug as noted in Protocol 0157.
- •8. Participating in or interested in participating in another investigational study (exception Protocol 0157)
- •9. Has clinically significant abnormalities in the results of laboratory evaluations at the most recent laboratory evaluation prior to LTS Day 1 visit as determined by the investigator, including:
- •AST, ALT, or alkaline phosphatase = 2x the upper limit of normal (ULN)
- •Total bilirubin > 2x ULN (unless diagnosis of Gilbert’s syndrome)
- •Creatinine clearance as calculated by the Cockcroft-Gault formula < 30 mL/min
- •Total white blood cell count (WBC) < 3 x 10^9/L
- •Absolute neutrophil count < 1.5 x 10^9/L
- •Absolute lymphocyte count < 0.8 x 10^9/L
- •Hemoglobin < 8 g/dL
- •Platelet count < 100 x 10^9/L.
- •10. Subject has had a live viral vaccine (e.g., MMR, varicella zoster, herpes zoster, oral polio virus, FluMist®, attenuated typhoid fever vaccine, attenuated rotavirus vaccine, yellow fever vaccine, or any
- •investigational live vaccine) within 4 weeks prior to Day 1 and/or is
- •unwilling or unable to avoid live viral vaccines during the Study and for 8
- •weeks following the last dose of study drug. Subject must be willing to avoid contact with any household member who has been vaccinated with a live attenuated vaccine within 2 weeks after vaccination.
- •11. Are pregnant, lactating, breastfeeding or planning to become
- •pregnant during the Study or within 7 days after the last dose of Study
- •12. Within 4 weeks of Day 1, has [1] confirmed severe acute respiratory
- •syndrome coronavirus 2 (SARS-CoV-2) infection (coronavirus disease
- •2019 [COVID-19]) (test positive), OR [2] suspected SARS-CoV-2
- •infection (clinical features without documented test results) unless has a
- •negative test for SARS-CoV-2 two weeks after resolution of symptoms
- •and remains asymptomatic until Day 1, OR [3] close contact with a person with known or suspected SAR
研究者
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