🏥 治験ポータル

治験一覧

8,963 件中 36813700 件を表示

中等度から重度の活動性クローン病患者におけるグセルクマブの有効性と安全性に関する研究

実施中(募集終了)NCT03466411第2/第3相

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.

対象疾患:
クローン病

胃癌または胃食道接合部(GEJ)腺癌患者におけるペムブロリズマブ(MK-3475)+化学療法とプラセボ+化学療法の比較(MK-3475-859/KEYNOTE-859)

完了NCT03675737第3相

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil \[FP regimen\] or oxaliplatin combined with capecitabine \[CAPOX regimen\]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).

対象疾患:
Stomach Neoplasms

進行または転移した固形癌患者を対象としたBMS-986258単独およびニボルマブとの併用による免疫療法試験

中止NCT03446040第1/第2相

The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

対象疾患:
Advanced Cancer

ホルモン受容体陽性、HER2陰性の進行乳がん女性に対するパルボシクリブとタモキシフェンの併用療法 - アジア人女性を対象とした研究

実施中(募集終了)NCT03423199第3相

This study is conducted to evaluate the benefit of adding palbociclib in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients, regardless of menopausal status, treated with tamoxifen (with or without goserelin) versus tamoxifen alone (with or without goserelin).

対象疾患:
Breast Neoplasms

ALSに対する超高用量メチルコバラミンの臨床試験

完了NCT03548311第3相

To examine the clinical efficacy and safety of ultra-high dose (50mg, im, twice a week) methylcobalamin in retarding the progression of symptoms in amyotrophic lateral sclerosis (ALS) patients, we enroll ALS patients diagnosed by Updated Awaji Criteria within 12 months after the clinical onset. First they are followed for 12 weeks with Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) scores, and only those who exhibit drops of 1-2 points are allowed to enter into the test period. A total of 128 patients are randomized and the half having placebo. They are blindly evaluated for drops of ALSFRS-R in 16 weeks, as the primary outcome. After this, all subjects receive methylcobalamin.

対象疾患:
Amyotrophic Lateral Sclerosis

特発性肺線維症(IPF)患者を対象に、標準治療と併用した場合のGLPG1690の有効性と安全性を検証する臨床試験

中止NCT03733444第3相

The main purpose of this study was to see how GLPG1690 works together with the current standard treatment on your lung function and IPF disease in general. The study also investigated how well GLPG1690 is tolerated (for example if you get any side effects while on study drug).

対象疾患:
Idiopathic Pulmonary Fibrosis

早期アルツハイマー病(AD)患者を対象としたガンテネルマブの有効性および安全性に関する研究

中止NCT03444870第3相

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.

対象疾患:
Alzheimer Disease

小児患者におけるネキシウムのS-CEI

完了NCT03562026

To capture safety and efficacy when Nexium are administered to pediatric patients in clinical practice after launch

対象疾患:
Peptic Ulcer, Gastroesophageal Reflux

LEO 90100フォーム(カルシポトリオール水和物とベタメタゾンプロピオン酸エステル)の健康な日本人被験者における皮膚刺激性試験

完了NCT03442244第1相

This trial is looking at whether the LEO 90100 foam causes irritation of the skin in healthy Japanese male adults without psoriasis. A single application of LEO 90100 foam and its vehicle will each be made to 2 body sites in 20 subjects.

対象疾患:
Psoriasis Vulgaris

EMPA-KIDNEY(エンパグリフロジンによる心臓および腎臓の保護に関する研究)

完了NCT03594110第3相

The primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease. After completion of the interventional part of the study (primary study completion) a subset of participants will be followed up in a post-trial observational (non-interventional) manner for cardio-renal outcomes (estimated study completion date).

対象疾患:
Chronic Kidney Disease

中等度から重度のアトピー性皮膚炎患者12歳以上における外用薬併用の有無によるPF-04965842の有効性と安全性を評価する試験

完了NCT03422822第3相

B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying parent study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country. The B7451015 study also includes a sub-study evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee MRI. The sub-study will be conducted in selected countries at selected sites. Eligible subjects are those who were 12 to \<18 years of age at the screening visit of the qualifying parent study and who are currently participating in the main B7451015 study. The sub-study will include serial Magnetic Resonance Imaging (MRI) annually and continue until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued/withdrawn.

対象疾患:
Dermatitis, Atopic

HFpEF患者におけるベリシグアト治療後の患者報告アウトカム

完了NCT03547583第2相

The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.

対象疾患:
Chronic Heart Failure With Preserved Ejection Fraction

NPC-12(シロリムス)顆粒剤および錠剤の生物学的同等性試験

完了NCT03765944第1相

The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with NPC-12T tablets in Japanese healthy Adults

対象疾患:
Bioequivalence Study

薬剤抵抗性てんかんを有する成人患者における焦点発作の補助療法としてのパドセボニルの安全性および有効性を検証する研究

中止NCT03370120第2相

The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.

対象疾患:
Drug-Resistant EpilepsyFocal-Onset Seizures

血液透析患者における限外濾過率の影響と生存率との関連性

完了NCT03471299

This study assesses retrospectively the association of mortality on UFR assessments in our study population undergoing HD.

対象疾患:
Hemodialysis

糖尿病性黄斑浮腫患者におけるファリシマブ(RO6867461)の有効性と安全性を評価する研究(YOSEMITE)

完了NCT03622580第3相

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

対象疾患:
Diabetic Macular Edema

肝硬変の追跡調査

完了NCT03472742

This is a follow-up study to assess safety and preliminary clinical activity of ADR-001 in patients with liver cirrhosis (Child-Pugh score; Grade B) caused by Hepatitis C or Nonalcoholic Steatohepatitis. Patients who have already participated in the ADR-001-01 study and completed the last evaluation after 24 weeks of administration will be eligible to this study. Patients registered will continue follow-up observation and evaluate long-term safety and exploratory efficacy.

対象疾患:
Decompensated Liver Cirrhosis

高尿酸血症の外来患者(痛風の有無を問わず)におけるFYU-981の有効性に関する研究(2種類の高尿酸血症に対する効果)

完了NCT03375632第1相

To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatients with or without gout.

対象疾患:
Hyperuricemia With or Without Gout

遺伝子改変T細胞治療を受けた参加者の長期追跡調査プロトコル

募集中NCT03435796第2/第3相

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

対象疾患:
Neoplasms

潰瘍性大腸炎におけるTD-1473の有効性および安全性

中止NCT03758443第2/第3相

A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

対象疾患:
Ulcerative Colitis (UC)