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特定の遺伝子変異(KRAS G12C)を有する癌患者におけるLY3537982の研究

募集中NCT04956640第1/第2相

The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.

対象疾患:
Biliary Tract NeoplasmsCarcinoma, Non-Small-Cell LungColorectal NeoplasmsEndometrial NeoplasmsOvarian Neoplasms1

非小細胞肺癌(NSCLC)患者を対象とした手術または放射線治療後のセルペルカチニブに関する研究

実施中(募集終了)NCT04819100第3相

The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.

対象疾患:
Carcinoma, Non-Small-Cell Lung

過体重または肥満の人におけるセマグルチド錠の1日1回服用の効果を調査する研究調査(OASIS 1)

完了NCT05035095第3相

This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation. Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes. Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning In addition to taking the medicine, participants will have talks with study staff about: * healthy food choices * how to be more physically active * what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits. Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.

対象疾患:
ObesityOverweight

円形脱毛症患者を対象としたJNJ-64304500の研究

取り下げNCT04740970第2相

The purpose of this study is to evaluate the clinical response of 22 weeks of study intervention with JNJ-64304500, compared with placebo, in participants with moderate to severe alopecia areata (AA).

対象疾患:
Alopecia Areata

ヒト免疫不全ウイルス1型(HIV-1)感染症患者を対象としたドラビリン/イスラトラビル(DOR/ISL 100 mg/0.75 mg)の非盲検追跡調査(MK-8591A-033)

実施中(募集終了)NCT04776252第3相

The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (100mg) and islatravir (0.75mg) \[DOR/ISL 100 mg/0.75 mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.

対象疾患:
HIV-1 Infection

慢性特発性蕁麻疹の成人患者におけるテゼペルマブの評価研究

完了NCT04833855第2相

The primary objective of this study is to evaluate the effect of tezepelumab on improvement in the Urticaria Activity Score over 7 days (UAS7).

対象疾患:
Chronic Spontaneous Urticaria

B細胞悪性腫瘍患者を対象としたBGB-16673の用量漸増および拡大試験

募集中NCT05006716第1/第2相

Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)

対象疾患:
B細胞悪性腫瘍慢性リンパ性白血病びまん性大細胞型B細胞リンパ腫濾胞性リンパ腫マントル細胞リンパ腫4

日常臨床診療における乾癬性関節炎患者を対象としたグセルクマブとインターロイキン-17(IL-17)阻害剤療法の研究

実施中(募集終了)NCT05049798

The purpose of this study is to evaluate treatment persistence with guselkumab and interleukin-17 inhibitor (IL-17i) initiated at enrollment into this study (PsABIOnd).

対象疾患:
関節炎、乾癬

健康な男性を対象としたBI 474121の忍容性試験

完了NCT04964453第1相

Safety, tolerability, and pharmacokinetics of BI 474121 will be assessed in healthy Japanese male using single rising oral doses in order to provide the basis for an ongoing clinical development of BI 474121 for the treatment of cognitive impairment in patients with Alzheimer's Disease and schizophrenia.

対象疾患:
Healthy

MLL再構成またはNPM1変異の有無にかかわらず再発性/難治性AML/ALLに対するDSP-5336の研究

募集中NCT04988555第1/第2相

A phase 1/2 dose escalation / dose expansion study of Enzomenib (DSP-5336) in adult patients with acute leukemia.

対象疾患:
Leukemia, Lymphocytic, AcuteLeukemia, Myeloid, Acute

アベニールの完全な市販後臨床追跡調査

実施中(募集終了)NCT04731077該当なし

The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty.

対象疾患:
Avascular Necrosis of HipAvascular Necrosis of the Femoral HeadOsteoarthritis, HipPost-traumatic; Arthrosis

進行性MTAP遺伝子変異陽性固形腫瘍患者を対象としたAMG 193試験(MTAPESTRY 101)

実施中(募集終了)NCT05094336第1/第2相

The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors. The primary objective of Part 3 of this study is to evaluate the efficacy of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors.

対象疾患:
Advanced MTAP-null Solid Tumors

再発性/難治性(R/R)濾胞性リンパ腫または辺縁帯リンパ腫患者を対象に、タファシタマブ+レナリドミドおよびリツキシマブの併用とプラセボ+レナリドミドおよびリツキシマブの併用を比較し、有効性と安全性を評価する第3相試験。

実施中(募集終了)NCT04680052第3相

This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

対象疾患:
Follicular LymphomaMarginal Zone Lymphoma

RESTORE - 二次性股関節骨折予防のためのAGN1 LOEPの研究

募集中NCT04796350該当なし

A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures. Up to 2400 subjects will be randomized between a treatment group and a control group. Subjects will be followed for a minimum of 5 years after undergoing hip fracture repair surgery.

対象疾患:
Fragility FractureHip FracturesOsteoporosis

胃癌治療歴のある患者におけるツサミタマブ・ラブタンシン(SAR408701)とラムシルマブの併用

中止NCT05071053第2相

Primary Objectives: Part 1: to confirm the recommended tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma population Part 2: to assess the antitumor activity of tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or GEJ adenocarcinoma Secondary Objectives: * To assess safety and tolerability * To assess durability of response (DOR) * To assess progression-free survival (PFS) * To assess the disease control rate (DCR) * To assess the pharmacokinetics (PK) * To assess the immunogenicity

対象疾患:
Adenocarcinoma GastricGastrooesophageal Cancer

ベピロビルセンの過去の試験参加者における治療反応の持続性を評価するための長期追跡調査(B-Sure)

募集中NCT04954859第2相

This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study and achieved a complete or partial response. Eligible participants will be enrolled in this study after completing the end of study (EoS) visit in the respective parent bepirovirsen studies (studies B-Clear \[209668: NCT04449029\], B-Together \[209348: NCT04676724\], B-Fine \[212602: NCT04544956\], B-Well 1 \[202009: NCT05630807\], B-Well 2 \[219288: NCT05630820\], and TH HBV ASO-001 \[217023: NCT05276297\]). Participants will be categorized as Not-on-NA, NA-cessated, or On-NA based on their nucleos(t)ide analogue (NA) status in the parent study. No further treatment with bepirovirsen will be administered in this study.

対象疾患:
Hepatitis B

慢性リンパ性白血病(CLL)/小リンパ球性リンパ腫(SLL)の未治療患者におけるピルトブルチニブ(LOXO-305)とベンダムスチン+リツキシマブ(BR)の併用療法を比較する試験

実施中(募集終了)NCT05023980第3相

The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

対象疾患:
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

中等度から重度の活動性潰瘍性大腸炎を有する日本人成人患者を対象とした、エトラシモドの用量設定試験とプラセボの比較による導入療法試験

完了NCT05061446第2相

The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.

対象疾患:
Ulcerative Colitis

成人における新型コロナウイルス感染症(COVID-19)予防のためのMK-4482の研究(MK-4482-013)

完了NCT04939428第3相

The purpose of the study is to assess if the study medication (molnupiravir, MK-4482) will prevent symptomatic coronavirus disease 2019 (COVID-19) in adults who live with someone with confirmed COVID-19 infection. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study; half of the study participants will receive molnupiravir twice daily by mouth and the other half will receive a placebo. The primary objectives of the study are to determine if molnupiravir prevents symptomatic COVID-19 disease and to evaluate its safety and tolerability. All participants who develop COVID-19 during the study are still eligible for any COVID-19 treatment recommended by their doctor.

対象疾患:
Coronavirus Disease (COVID-19)

短腸症候群の日本人患者におけるテドグルチドの研究

募集中NCT05023382

The main aims of this study are to check for side effects from treatment with teduglutide (Revestive) and how well teduglutide controls symptoms of short bowel syndrome. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. During the study, participants with short bowel syndrome will receive an injection of teduglutide just under the skin (subcutaneous) according to their clinic's standard practice. The study doctors will check for side effects from teduglutide for 36 months.

対象疾患:
Short Bowel Syndrome