JPRN-jRCT2051210050进行中（未招募）2 期
A Phase 2, Double-Blind, Randomized, Active Controlled Study to Evaluate Dose-Response of TAS-115 in Patients with Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype
Motoo Yoshiharu0 个研究点目标入组 240 人开始时间: 2021年7月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1)Provide written informed consent
- •(2)Patients whose age at the time of informed consent is >= 20 years
- •(3)Patients who have been given a diagnosis of interstitial lung disease by the investigator and have received nintedanib or pirfenidone for at least 90 days at Visit 1 for any of the approved indications
- •(4)Pulmonary fibrosis of > 10% of all lung fields observed from central reading of chest high-resolution computed tomography (HRCT) at Visit 1
- •(5)Patients who meet the following criteria for progressiveness:
- •Decline in percent predicted forced vital capacity (%FVC) based on a relative decline of >= 5%/year at Visit 1, as follows
- •(Basepoint %FVC - Visit 1 %FVC) / Basepoint %FVC x 365 (days) / Measurement interval (days) x 100 >= 5%
- •However, if the measurement interval is less than 365 days for decline in %FVC, a relative decline of >= 5% is required as follows:
- •(Basepoint %FVC - Visit 1 %FVC) / Basepoint %FVC x 100 >= 5%
- •The basepoint data are defined as measured data of the earliest date among the previous data obtained immediately before the start of or during the treatment with antifibrotic drugs (nintedanib or pirfenidone) that have been administered at Visit 1, excluding those with a clear reason such as incorrect measurement. The interval between the measurement date of basepoint data and the measurement at Visit 1 should be at least 90 days apart.
- •(6)Difference between the FVC at Visit 2 and the FVC at Visit 1 of =< +5% or =< 150 mL, as calculated below:
- •(FVC at Visit 2- FVC at Visit 1) / FVC at Visit 1 x 100 =< 5%
- •Or FVC at Visit 2 - FVC =< 150 mL at Visit 1
- •(7)Patients with a %FVC: >= 50% at Visit 2
- •(8)Percent predicted diffusing capacity for carbon monoxide (%DLco) [corrected for the hemoglobin (Hb) level at Visit 1] of >= 25%
- •(9)Patients who have not started or discontinued treatment other than nintedanib or pirfenidone for interstitial lung disease within 42 days before randomization
- •(10)The extent of fibrotic changes is greater than the extent of emphysema on chest HRCT scan at Visit 1 (the central review will be performed, but the final decision will be made by the investigator).
- •(11)Patients who can take medication orally
排除标准
- •(1)Patients with a history of TAS-115 use
- •(2)Patients who received the following treatment during the specified period before randomization in this study
- •a)Major surgery within 28 days before randomization (surgical wounds have to be healed before randomization)
- •b)Patients who received nintedanib or pirfenidone within 7 days before randomization
- •c)Treatment with another investigational product within 5 half-lives prior to randomization in this study (if half-life is unknown, 56 days must have elapsed)
- •(3)Patients with airflow obstruction (percent forced expiratory volume in 1 second [FEV1/FVC] before treatment with a bronchodilator is < 0.7 at Visit 2)
- •(4)Patients given a diagnosis of severe pulmonary hypertension
- •(5)Patients with medical history of acute exacerbation of interstitial lung disease
- •(6)Patients with a history of hypersensitivity to any component of TAS-115
- •(7)Patients with moderate or severe adverse drug reactions to prior treatment for moderate or severe decreased appetite, malaise, diarrhoea, nausea, skin disorder or interstitial lung disease (excluding alopecia and pigmentation)
- •(8)Pregnant or lactating women
- •(9)Male patients or female patients of childbearing potential who do not agree to use appropriate contraception during the following period:
- •Male patients: During the study and for 4 months after the last dose of study drug
- •Female patients of childbearing potential: During the study and for 7 months after the last dose of study drug
研究者
相似试验
进行中（未招募）
1 期
Study to Evaluate the Efficacy and Safety of Miconazole Nitrate 2% + Domiphen Bromide Vaginal cream in the Treatment of Subjects with Acute Vulvovaginal CandidiasisEUCTR2021-001201-75-BEFemale Healthcare Purna95
进行中（未招募）
1 期
Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC).Primary biliary cholangitisMedDRA version: 27.0Level: PTClassification code: 10080429Term: Primary biliary cholangitis Class: 100000004871CTIS2024-513584-77-00Intercept Pharmaceuticals Inc.60
进行中（未招募）
1 期
Efficacy, safety and tolerability of AZD9977 and dapagliflozin in patients with heart failure and chronic kidney diseaseHeart Failure and Chronic Kidney DiseaseMedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2020-003126-23-SKAstraZeneca AB500
招募中
1 期
Phase 2 study comparing INBRX-101 to plasma-derived A1PI therapy for AATD emphysemaAlpha-1 Antitrypsin Deficiency (AATD) EmphysemaMedDRA version: 23.1Level: LLTClassification code: 10001806Term: Alpha-1 anti-trypsin deficiency Class: 10010331CTIS2023-508084-76-00Inhibrx Inc.94
进行中（未招募）
1 期
A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitislcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2018-001510-15-PLJanssen-Cilag International NV210