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ジェネンテック社および/またはF.ホフマン・ラ・ロシュ社がスポンサーとなったアテゾリズマブ研究に以前登録された患者を対象とした研究

実施中(募集終了)NCT03768063第3相

This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or combination/comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.

対象疾患:
Cancer

統合失調症に伴う認知機能障害(CIAS)を有する参加者におけるBIIB104の安全性および有効性を評価するための研究

完了NCT03745820第2相

The primary objective of the study is to evaluate the efficacy of BIIB104 in participants with CIAS, using the Working Memory Domain of the MATRICS Consensus Cognitive Battery (MCCB). The secondary objectives of this study are to evaluate the safety and tolerability of BIIB104 in participants with CIAS, and to evaluate the efficacy of BIIB104 in participants with CIAS on measures of cognition, functioning, and psychiatric symptomology.

対象疾患:
Cognitive Impairment Associated With Schizophrenia

アグリリン薬の使用結果調査

完了NCT03625895

The objective of this survey is to collect data to evaluate the safety and efficacy of anagrelide hydrochloride in the post-marketing phase in participants diagnosed with Essential Thrombocythemia (ET).

対象疾患:
Essential Thrombocythemia (ET)

透析患者における腎性貧血の改善を目的としたモリデュスタットの研究

完了NCT03351166第3相

The purpose of this study is to evaluate the efficacy and safety of Molidustat in dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)

対象疾患:
AnemiaRenal Insufficiency, Chronic

ペンブロリズマブ(MK-3475)試験(MK-3475-587/KEYNOTE-587)で現在治療中または追跡調査中の進行腫瘍患者を対象とした長期安全性および有効性延長試験

募集中NCT03486873第3相

The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.

対象疾患:
造血悪性腫瘍固形腫瘍

中等度から重度のアトピー性皮膚炎の成人患者を対象に、既存の外用療法下でPF-04965842とデュピルマブの有効性および安全性を評価する研究

完了NCT03720470第3相

B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily will be evaluated relative to placebo over 12 weeks. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment.

対象疾患:
DermatitisDermatitis, AtopicEczemaGenetic Diseases, InbornHypersensitivity5

ヒトメタニューモウイルスに感染した入院成人患者における経口ルミシタビン投与レジメンの抗ウイルス活性、臨床転帰、安全性、忍容性、および薬物動態

取り下げNCT03502694第2相

The purpose of this study is to determine in hospitalized adult participants infected with human metapneumovirus (hMPV - a virus closely related to respiratory syncytial virus (RSV) and has been identified as an important cause of acute respiratory infections, affecting all age groups) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal hMPV shedding using quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.

対象疾患:
Metapneumovirus

双極性障害に伴ううつ病患者におけるクエチアピン徐放錠に関する調査

完了NCT03403790

The purpose of this study is to evaluate the safety and effectiveness of quetiapine in actual clinical settings.

対象疾患:
Bipolar DisorderDepression

この研究は、様々な種類の進行癌(固形腫瘍)患者におけるBI 907828(ブリギマドリン)の最適な投与量を見つけることを目的としている。

完了NCT03449381第1相

This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the second part to find out whether brigimadlin makes tumors shrink. In this study, brigimadlin is given to humans for the first time. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Brigimadlin is taken as a tablet. Participants either take a dose of brigimadlin on one day every 3 weeks or on two days every 4 weeks. The participants are in the study for as long as they benefit from and can tolerate treatment. The doctors regularly check the participants' general health during the study.

対象疾患:
Neoplasms

アレクチニブまたはセリチニブ投与中に進行した未分化リンパ腫キナーゼ陽性(ALK+)進行非小細胞肺癌(NSCLC)患者を対象としたブリガチニブの試験

完了NCT03535740第2相

The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors \[RECIST\]), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.

対象疾患:
ALK-positive Advanced NSCLC

切除された高リスクステージII黒色腫患者におけるペムブロリズマブとプラセボの安全性および有効性の比較(MK-3475-716/KEYNOTE-716)

実施中(募集終了)NCT03553836第3相

This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/\~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo. Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively.

対象疾患:
Melanoma

卵巣がん患者を対象とした、プラチナ製剤をベースとした第一選択化学療法への反応後の維持療法としてルカパリブとニボルマブを評価する研究

実施中(募集終了)NCT03522246第3相

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

対象疾患:
Complete ResponseEpithelial Ovarian CancerFIGO Stage III-IVFallopian Tube CancerNewly Diagnosed2

TS-143の健康成人男性を対象とした臨床試験(単回投与)

完了NCT03591133第1相

To investigate the safety, pharmacokinetics and pharmacodynamics when administering a single dose of TS-143 to Japanese healthy adult males using a placebo-controlled, double-blind, dose-ascending study, in addition to the effects of meals.

対象疾患:
Healthy Participants

健康な男性被験者におけるE2082の安全性、忍容性、および薬物動態を評価するための研究

中止NCT03402178第1相

This study will be conducted to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending oral doses of E2082 in healthy Japanese adult and elderly male participants, and to evaluate the safety, tolerability, and PK of multiple ascending oral doses of E2082 in healthy Japanese and Caucasian adult male participants.

対象疾患:
Healthy Participants

自閉症スペクトラム障害に対するTTA-121の臨床試験

不明NCT03466671第2相

To test efficacy and safety of a novel nasal spray of oxytocin on social deifies in autism spectrum disorder, and To compare effect sizes of different doses

対象疾患:
Autism Spectrum Disorder

活動性全身性エリテマトーデス患者を対象としたウステキヌマブの研究

中止NCT03517722第3相

The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.

対象疾患:
Lupus Erythematosus, Systemic

がん患者を対象としたPF-06873600の研究

中止NCT03519178第1/第2相

The purpose of this clinical trial is to learn about the safety and effects of study medicine (PF-06873600) when taken alone or with hormone therapy by people with cancer. People may be able to participate in this study if they have the following types of cancer: Hormone Receptor positive (HR+) breast cancer; Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer that is advanced or metastatic (spread to other parts of the body); triple negative breast cancer; epithelial ovarian cancer; fallopian tube cancer; or primary peritoneal cancer. All participants in this study will receive the study medicine by mouth, 1 to 2 times a day at home. The dose of the study medicine may be changed during the study. Some participants will also receive hormone therapy. The hormone therapy will be either letrozole by mouth once a day at home, or fulvestrant as a shot into the muscle. Fulvestrant will be given every two weeks at the study clinic for the first month, and then once a month after that. Participants will take part in this study for at least 7 to 8 months, depending on how they respond to the therapy. During this time participants will visit the study clinic once a week for the first 2 cycles and every cycle thereafter.

対象疾患:
HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer

中等度から重度の活動性潰瘍性大腸炎患者を対象としたミリキズマブの導入試験(LUCENT 1)

完了NCT03518086第3相

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

対象疾患:
Ulcerative Colitis

肝細胞癌患者を対象としたレンバチニブとニボルマブの併用療法に関する研究

完了NCT03418922第1相

The primary objective of this study is to evaluate the tolerability and safety of a combination of lenvatinib plus nivolumab in participants with hepatocellular carcinoma (HCC).

対象疾患:
Carcinoma, Hepatocellular

ラサギリン錠 特殊医薬品使用結果調査「長期安全性に関する調査」

完了NCT03727139

The purpose of this survey is to evaluate the long-term safety of Rasagiline (AZILECT) in patients with Parkinson's disease in daily clinical practice and also collect efficacy information.

対象疾患:
Parkinson's Disease