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利用者名:
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試験進捗状況 開始前/Preinitiation
UMIN試験ID UMIN000045735
受付番号 R000052211
科学的試験名 セリアック病に対する治療薬の研究
一般公開日(本登録希望日) 2021/10/12
最終更新日 2021/10/13

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title セリアック病に対する治療薬の研究 Research on therapeutic drugs for celiac disease
一般向け試験名略称/Acronym セリアック病に対する治療薬の研究 Research on therapeutic drugs for celiac disease
科学的試験名/Scientific Title セリアック病に対する治療薬の研究 Research on therapeutic drugs for celiac disease
科学的試験名略称/Scientific Title:Acronym セリアック病に対する治療薬の研究 Research on therapeutic drugs for celiac disease
試験実施地域/Region
オセアニア/Australia

対象疾患/Condition
対象疾患名/Condition セリアック病 celiac disease
疾患区分1/Classification by specialty
消化器内科学(肝・胆・膵)/Hepato-biliary-pancreatic medicine
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information はい/YES

目的/Objectives
目的1/Narrative objectives1 セリアック病治療薬の効果を評価する Evaluating the effectiveness of therapeutic drugs for celiac disease
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes ELISPOT assay ELISPOT assay
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 単群/Single arm
ランダム化/Randomization 非ランダム化/Non-randomized
ランダム化の単位/Randomization unit
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無対照/Uncontrolled
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 1
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
食品/Food
介入1/Interventions/Control_1 グルテンチャレンジ Gluten challenge
介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
18 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
70 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria 1.Signed and understands the informed consent form.
2.Age between 18 to 70 years of age (inclusive) who have signed an informed consent form.
3.Positive for either of the HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02), HLA-DQ8 (HLA-DQA1*03 and DQB1*0302) or HLA-DQ2.2
4.Able and willing to consume up to 4 slices of wheat bread daily for 3 consecutive days, and provide a total of one unit of blood equivalent to a blood donation.
5.Able to read and understand English.
6.Medically diagnosed with CeD on the basis of a biopsy.
7.Followed GFD for at least 3 months.
1.Signed and understands the informed consent form.
2.Age between 18 to 70 years of age (inclusive) who have signed an informed consent form.
3.Positive for either of the HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02), HLA-DQ8 (HLA-DQA1*03 and DQB1*0302) or HLA-DQ2.2
4.Able and willing to consume up to 4 slices of wheat bread daily for 3 consecutive days, and provide a total of one unit of blood equivalent to a blood donation.
5.Able to read and understand English.
6.Medically diagnosed with CeD on the basis of a biopsy.
7.Followed GFD for at least 3 months.
除外基準/Key exclusion criteria 1.History of known Immunoglobulin E -mediated reaction to wheat, barley or Rye
2.Unable to provide documentation of duodenal histology that reports villous atrophy, and of elevated serum transglutaminase-specific IgA, IgA endomysial immunofluorescence (EMA), or for IgA deficient individuals then DGP IgG.
3.Medication within 3 months that might suppress cellular immunity (e.g. oral or parental corticosteroids, immunosuppressive medication)
4.Any medical condition that in the opinion of the investigator may interfere with study conduct.
5.Any medical condition that in the opinion of the investigator would impact the immune response, confound interpretation of study results, or pose an increased risk to the patient.
6.Haemoglobin level or platelet count at screening that is outside the normal gender-specific and age-specific range
7.Individual has uncontrolled medical conditions that in the opinion of the investigator, would increase the risk of blood collection to the patient. For guidance see American Red Cross Blood Donation eligibility criteria
8.Blood donation (one unit of blood) within the previous 8 weeks.
9.Heart disease with heart related symptoms.
10.Heart murmur, or heart valve disorder that has not been medically evaluated, or has caused symptoms within the last 6 months, and is associated with restrictions on normal daily activities.
11.Any medical condition or therapy resulting in impaired blood clotting and bleeding.
12.Body weight less than 50 kg.
13.The pregnant.
14.Vital signs outside the range: systolic blood pressure 90 to 180 mm Hg, diastolic blood pressure 60 to 100 mm Hg, pulse rate regular and 50 to 100 per minute, or body temperature exceeding 99.5oF.
1.History of known Immunoglobulin E -mediated reaction to wheat, barley or Rye
2.Unable to provide documentation of duodenal histology that reports villous atrophy, and of elevated serum transglutaminase-specific IgA, IgA endomysial immunofluorescence (EMA), or for IgA deficient individuals then DGP IgG.
3.Medication within 3 months that might suppress cellular immunity (e.g. oral or parental corticosteroids, immunosuppressive medication)
4.Any medical condition that in the opinion of the investigator may interfere with study conduct.
5.Any medical condition that in the opinion of the investigator would impact the immune response, confound interpretation of study results, or pose an increased risk to the patient.
6.Haemoglobin level or platelet count at screening that is outside the normal gender-specific and age-specific range
7.Individual has uncontrolled medical conditions that in the opinion of the investigator, would increase the risk of blood collection to the patient. For guidance see American Red Cross Blood Donation eligibility criteria
8.Blood donation (one unit of blood) within the previous 8 weeks.
9.Heart disease with heart related symptoms.
10.Heart murmur, or heart valve disorder that has not been medically evaluated, or has caused symptoms within the last 6 months, and is associated with restrictions on normal daily activities.
11.Any medical condition or therapy resulting in impaired blood clotting and bleeding.
12.Body weight less than 50 kg.
13.The pregnant.
14.Vital signs outside the range: systolic blood pressure 90 to 180 mm Hg, diastolic blood pressure 60 to 100 mm Hg, pulse rate regular and 50 to 100 per minute, or body temperature exceeding 99.5oF.
目標参加者数/Target sample size 60

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
敬弘
ミドルネーム
石黒
Takahiro
ミドルネーム
Ishiguro
所属組織/Organization 中外製薬株式会社 Chugai Pharmaceutical Co., Ltd.
所属部署/Division name 医科学薬理部 Pharmaceutical Science Dept.
郵便番号/Zip code 1038324
住所/Address 東京都中央区日本橋室町2-1-1 1-1 Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo
電話/TEL 03-3281-6611
Email/Email DQB0001-TR@chugai-pharm.co.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person
洋介
ミドルネーム
村上
Yosuke
ミドルネーム
Murakami
組織名/Organization 中外製薬株式会社 Chugai Pharmaceutical Co., Ltd.
部署名/Division name 早期臨床開発部 Early Clinical Development Dept.
郵便番号/Zip code 1038324
住所/Address 東京都中央区日本橋室町2-1-1 1-1 Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo
電話/TEL 03-3281-6611
試験のホームページURL/Homepage URL
Email/Email DQB0001-TR@chugai-pharm.co.jp

実施責任組織/Sponsor
機関名/Institute 中外製薬株式会社 Chugai Pharmaceutical Co., Ltd.
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization 無し None
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization The Royal Melbourne Hospital The Royal Melbourne Hospital
住所/Address Level 2 South West 300 Grattan Street Parkville VIC 3050 Australia Level 2 South West 300 Grattan Street Parkville VIC 3050 Australia
電話/Tel +61393428530
Email/Email research@mh.org.au

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2021 10 12

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 開始前/Preinitiation
プロトコル確定日/Date of protocol fixation
2021 10 12
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2021 11 01
フォロー終了(予定)日/Last follow-up date
2022 07 30
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2021 10 12
最終更新日/Last modified on
2021 10 13


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000052211
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052211

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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