Tacrolimus versus mycophenolate for AutoImmune hepatitis patients with incompLete response On first-line therapy (TAILOR study): a study protocol for a phase III, open-label, multicentre, randomised controlled trial

被引:0
|
作者
Anna E. C. Stoelinga
Maarten E. Tushuizen
Wilbert B. van den Hout
Mar D. M. Rodriguez Girondo
Elsemieke S. de Vries
Amar D. Levens
Dirk-Jan A. R. Moes
Tom J. G. Gevers
Suzanne van der Meer
Hans T. Brouwer
Hendrik J. M. de Jonge
Ynte S. de Boer
Ulrich H. W. Beuers
Adriaan J. van der Meer
Aad P. van den Berg
Maureen M. J. Guichelaar
Joost P. H. Drenth
Bart van Hoek
机构
[1] Leiden University Medical Center,Department of Gastroenterology and Hepatology
[2] Leiden University Medical Center,Department of Biomedical Data Sciences
[3] Isala Hospital,Department of Gastroenterology and Hepatology
[4] Leiden University Medical Center,Department of Clinical Pharmacy and Toxicology
[5] Maastricht University Medical Center,Division of Gastroenterology and Hepatology, Department of Internal Medicine
[6] European Reference Network RARE-LIVER,Department of Gastroenterology and Hepatology
[7] University Medical Center Utrecht,Department of Gastroenterology and Hepatology
[8] Reinier de Graaf Gasthuis,Department of Gastroenterology and Hepatology
[9] Jeroen Bosch Hospital,Department of Gastroenterology and Hepatology
[10] Amsterdam University Medical Centre,Department of Gastroenterology and Hepatology
[11] Location VU University Medical Center,Department of Gastroenterology and Hepatology
[12] Amsterdam University Medical Centre,Department of Gastroenterology and Hepatology
[13] Location Academic Medical Center,Department of Gastroenterology and Hepatology
[14] Erasmus University Medical Center,Department of Gastroenterology and Hepatology
[15] University Medical Center Groningen,Department of Gastroenterology and Hepatology
[16] Medisch Spectrum Twente,Department of Gastroenterology and Hepatology
[17] Radboud University Medical Center,Department of Gastroenterology and Hepatology
[18] Elisabeth Tweesteden Hospital,Department of Gastroenterology and Hepatology
[19] Rijnstate Hospital,undefined
[20] Haaglanden Medical Center,undefined
[21] Rode Kruis Hospital,undefined
来源
Trials | / 25卷
关键词
AIH; Autoimmune hepatitis; Autoimmune liver disease; Tacrolimus; Mycophenolate mofetil; Randomised controlled trials; Second-line treatment; Complete biochemical response;
D O I
暂无
中图分类号
学科分类号
摘要
引用
收藏
相关论文
共 50 条
  • [1] Tacrolimus versus mycophenolate for AutoImmune hepatitis patients with incompLete response On first-line therapy (TAILOR study): a study protocol for a phase III, open-label, multicentre, randomised controlled trial
    Stoelinga, Anna E. C.
    Tushuizen, Maarten E.
    van den Hout, Wilbert B.
    Girondo, Mar D. M. Rodriguez
    de Vries, Elsemieke S.
    Levens, Amar D.
    Moes, Dirk-Jan A. R.
    Gevers, Tom J. G.
    van der Meer, Suzanne
    Brouwer, Hans T.
    de Jonge, Hendrik J. M.
    de Boer, Ynte S.
    Beuers, Ulrich H. W.
    van der Meer, Adriaan J.
    van den Berg, Aad P.
    Guichelaar, Maureen M. J.
    Drenth, Joost P. H.
    van Hoek, Bart
    TRIALS, 2024, 25 (01)
  • [2] Sequential versus triple therapy for the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial
    Liou, Jyh-Ming
    Chen, Chieh-Chang
    Chen, Mei-Jyh
    Chen, Chien-Chuan
    Chang, Chi-Yang
    Fang, Yu-Jen
    Lee, Ji-Yuh
    Hsu, Shih-Jer
    Luo, Jiing-Chyuan
    Chang, Wen-Hsiung
    Hsu, Yao-Chun
    Tseng, Cheng-Hao
    Tseng, Ping-Huei
    Wang, Hsiu-Po
    Yang, Ueng-Cheng
    Shun, Chia-Tung
    Lin, Jaw-Town
    Lee, Yi-Chia
    Wu, Ming-Shiang
    LANCET, 2013, 381 (9862): : 205 - 213
  • [3] Prone versus lateral position in acute hypoxemic respiratory failure patients with HFNO therapy: study protocol for a multicentre randomised controlled open-label trial
    Zhou, Xixin
    Luo, Xiaoqing
    Li, Qin
    Chen, Guihua
    Tong, Jin
    Deng, Wang
    TRIALS, 2023, 24 (01)
  • [4] Prone versus lateral position in acute hypoxemic respiratory failure patients with HFNO therapy: study protocol for a multicentre randomised controlled open-label trial
    Xixin Zhou
    Xiaoqing Luo
    Qin Li
    Guihua Chen
    Jin Tong
    Wang Deng
    Trials, 24
  • [5] APPROACH: Analysis of Proton versus Photon Radiotherapy in Oligodendroglioma and Assessment of Cognitive Health - study protocol paper for a phase III multicentre, open-label randomised controlled trial
    Slevin, Finbar
    Hudson, Eleanor Mae
    Boele, Florien W.
    Powell, James R.
    Noutch, Samantha
    Borland, Myfanwy
    Brown, Sarah
    Bruce, Anna
    Bulbeck, Helen
    Burnet, Neil G.
    Chang, Yen Ching
    Colaco, Rovel
    Currie, Stuart
    Egleston, Daniel
    Fersht, Naomi
    Klein, Martin
    Lilley, John
    Lowe, Matthew
    Miles, Elizabeth
    Murray, Robert D.
    O'Hara, Daniel J.
    Norris, Matthew
    Parbutt, Catherine
    Smith, Alexandra
    Smith, Charlotte
    Whitfield, Gillian A.
    Short, Susan
    Murray, Louise
    BMJ OPEN, 2025, 15 (02):
  • [6] Pemafibrate for treating MASLD complicated by hypertriglyceridaemia: a multicentre, open-label, randomised controlled trial study protocol
    Iwaki, Michihiro
    Kobayashi, Takashi
    Nogami, Asako
    Ogawa, Yuji
    Imajo, Kento
    Sakai, Eiji
    Nakada, Yoshinobu
    Koyama, Satoshi
    Kurihashi, Takeo
    Oza, Noriko
    Kohira, Toshikazu
    Okada, Michiaki
    Yamaguchi, Yuki
    Iwane, Shinji
    Kageyama, Fujito
    Sasada, Yuzo
    Matsushita, Masahiro
    Tadauchi, Akimitsu
    Murohisa, Gou
    Nagasawa, Masamichi
    Sato, Shuichi
    Maeda, Kazuhisa
    Furuta, Koichiro
    Shigefuku, Ryuta
    Seko, Yuya
    Tobita, Hiroshi
    Kawata, Kazuhito
    Kawanaka, Miwa
    Sugihara, Takaaki
    Tamaki, Nobuharu
    Iwasa, Motoh
    Kawaguchi, Takumi
    Itoh, Yoshito
    Kawaguchi, Atsushi
    Takahashi, Hirokazu
    Nakajima, Atsushi
    Yoneda, Masato
    BMJ OPEN, 2024, 14 (11):
  • [7] Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: a randomised open-label phase 3 trial
    Hutson, Thomas E.
    Lesovoy, Vladimir
    Al-Shukri, Salman
    Stus, Viktor P.
    Lipatov, Oleg N.
    Bair, Angel H.
    Rosbrook, Brad
    Chen, Connie
    Kim, Sinil
    Vogelzang, Nicholas J.
    LANCET ONCOLOGY, 2013, 14 (13): : 1287 - 1294
  • [8] Assessing the efficacy and safety of mycophenolate mofetil versus azathioprine in patients with autoimmune hepatitis (CAMARO trial): study protocol for a randomised controlled trial
    Romée J. A. L. M. Snijders
    Anna E. C. Stoelinga
    Tom J. G. Gevers
    Simon Pape
    Maaike Biewenga
    Robert C. Verdonk
    Hendrik J. M. de Jonge
    Jan Maarten Vrolijk
    Sjoerd F. Bakker
    Thomas Vanwolleghem
    Ynto S. de Boer
    Martine A. M. C. Baven Pronk
    Ulrich H. W. Beuers
    Adriaan J. van der Meer
    Nicole M. F. van Gerven
    Marijn G. M. Sijtsma
    Bart J. Verwer
    Ingrid A. M. Gisbertz
    Maartje Bartelink
    Floris F. van den Brand
    Kerem Sebib Korkmaz
    Aad P. van den Berg
    Maureen M. J. Guichelaar
    Khalida Soufidi
    Amar D. Levens
    Bart van Hoek
    Joost P. H. Drenth
    Trials, 23
  • [9] Assessing the efficacy and safety of mycophenolate mofetil versus azathioprine in patients with autoimmune hepatitis (CAMARO trial): study protocol for a randomised controlled trial
    Snijders, Romee J. A. L. M.
    Stoelinga, Anna E. C.
    Gevers, Tom J. G.
    Pape, Simon
    Biewenga, Maaike
    Verdonk, Robert C.
    de Jonge, Hendrik J. M.
    Vrolijk, Jan Maarten
    Bakker, Sjoerd F.
    Vanwolleghem, Thomas
    de Boer, Ynto S.
    Pronk, Martine A. M. C. Baven
    Beuers, Ulrich H. W.
    van Der Meer, Adriaan J.
    van Gerven, Nicole M. F.
    Sijtsma, Marijn G. M.
    Verwer, Bart J.
    Gisbertz, Ingrid A. M.
    Bartelink, Maartje
    van den Brand, Floris F.
    Korkmaz, Kerem Sebib
    van den Berg, Aad P.
    Guichelaar, Maureen M. J.
    Soufidi, Khalida
    Levens, Amar D.
    van Hoek, Bart
    Drenth, Joost P. H.
    TRIALS, 2022, 23 (01)
  • [10] An open-label phase II study of sorafenib and dacarbazine as first-line therapy in patients with advanced melanoma
    Eisen, T.
    Marais, R.
    Affolter, A.
    Lorigan, P.
    Ottensmeier, C.
    Robert, C.
    Corrie, P.
    Chevreau, C.
    Erlandsson, F.
    Gore, M.
    JOURNAL OF CLINICAL ONCOLOGY, 2007, 25 (18)