EUCTR2018-002135-19-PT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
- 46
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 Maintenance Study (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
- •adenomas with low grade dysplasia that have been completely resected
- •are eligible
- •5. Taking any medications/treatments 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 [e.g., 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
- •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
- 另有 5 项未显示
研究者
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