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 10 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] 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)
  • [3] 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
  • [4] First-line rituximab combined with short-term prednisone versus prednisone alone for the treatment of pemphigus (Ritux 3): a prospective, multicentre, parallel-group, open-label randomised trial
    Joly, Pascal
    Maho-Vaillant, Maud
    Prost-Squarcioni, Catherine
    Hebert, Vivien
    Houivet, Estelle
    Calbo, Sebastien
    Caillot, Frederique
    Golinski, Marie Laure
    Labeille, Bruno
    Picard-Dahan, Catherine
    Paul, Carle
    Richard, Marie-Aleth
    Bouaziz, Jean David
    Duvert-Lehembre, Sophie
    Bernard, Philippe
    Caux, Frederic
    Alexandre, Marina
    Ingen-Housz-Oro, Saskia
    Vabres, Pierre
    Delaporte, Emmanuel
    Quereux, Gaelle
    Dupuy, Alain
    Debarbieux, Sebastien
    Avenel-Audran, Martine
    D'Incan, Michel
    Bedane, Christophe
    Beneton, Nathalie
    Jullien, Denis
    Dupin, Nicolas
    Misery, Laurent
    Machet, Laurent
    Beylot-Barry, Marie
    Dereure, Olivier
    Sassolas, Bruno
    Vermeulin, Thomas
    Benichou, Jacques
    Musette, Philippe
    LANCET, 2017, 389 (10083) : 2031 - 2040
  • [5] Impact of switching from mycophenolate mofetil to enteric-coated mycophenolate sodium on gastrointestinal side effects in patients with autoimmune disease: a Phase III, open-label, single-arm, multicenter study
    Manger, Bernhard
    Hiepe, Falk
    Schneider, Matthias
    Worm, Margitta
    Wimmer, Peter
    Paulus, Eva-Maria
    Schwarting, Andreas
    CLINICAL AND EXPERIMENTAL GASTROENTEROLOGY, 2015, 8 : 205 - 213
  • [6] Study protocol of an open-label, single arm phase II trial investigating the efficacy and safety of Trifluridine/Tipiracil combined with irinotecan as a second line therapy in patients with cholangiocarcinoma (TRITICC)
    Kehmann, Linde
    Berres, Marie-Luise
    Gonzalez-Carmona, Maria
    Modest, Dominik P.
    Mohr, Raphael
    Wree, Alexander
    Venerito, Marino
    Strassburg, Christian
    Keitel, Verena
    Trautwein, Christian
    Luedde, Tom
    Roderburg, Christoph
    BMC CANCER, 2023, 23 (01)
  • [7] Study protocol of an open-label, single arm phase II trial investigating the efficacy and safety of Trifluridine/Tipiracil combined with irinotecan as a second line therapy in patients with cholangiocarcinoma (TRITICC)
    Linde Kehmann
    Marie-Luise Berres
    Maria Gonzalez-Carmona
    Dominik P. Modest
    Raphael Mohr
    Alexander Wree
    Marino Venerito
    Christian Strassburg
    Verena Keitel
    Christian Trautwein
    Tom Luedde
    Christoph Roderburg
    BMC Cancer, 23
  • [8] Open-Label, Multicenter Phase II Study of Combination Therapy of Imatinib Mesylate and Mycophenolate Mofetil in Pediatric Patients with Steroid-Refractory Sclerotic/Fibrotic Type Chronic Graft-versus-Host Disease
    Choi, Jung Yoon
    Kim, Hyery
    Baek, Hee Jo
    Kook, Hoon
    Lee, Jae Min
    Kim, Bo Kyung
    An, Hong Yul
    Hong, Kyung Taek
    Shin, Hee Young
    Kang, Hyoung Jin
    TRANSPLANTATION AND CELLULAR THERAPY, 2021, 27 (11): : 925.e1 - 925.e7
  • [9] Design rationale of the ATHENA study - A 12-month, multicentre, prospective study evaluating the outcomes of a de novo everolimus-based regimen in combination with reduced cyclosporine or tacrolimus versus a standard regimen in kidney transplant patients: study protocol for a randomised controlled trial
    Sommerer, Claudia
    Suwelack, Barbara
    Dragun, Duska
    Schenker, Peter
    Hauser, Ingeborg A.
    Nashan, Bjoern
    Thaiss, Friedrich
    TRIALS, 2016, 17
  • [10] Efficacy, safety and cost-effectiveness of methotrexate, adalimumab or their combination in non-infectious non-anterior uveitis: a protocol for a multicentre, randomised, parallel three arms, active-controlled, phase III open label with blinded outcome assessment study
    Belen Rivas, Ana
    Lopez-Picado, Amanda
    Calamia, Valentina
    Carreno, Ester
    Cocho, Lidia
    Cordero-Coma, Miguel
    Fonollosa, Alex
    Francisco Hernandez, Felix M.
    Garcia-Aparicio, Angel
    Garcia-Gonzalez, Javier
    Juan Mondejar, Jose
    Lojo-Oliveira, Leticia
    Martinez-Costa, Lluci
    Munoz, Santiago
    Peiteado, Diana
    Antonio Pinto, Jose
    Rodriguez-Lozano, Beatriz
    Pato, Esperanza
    Diaz-Valle, David
    Molina, Elena
    Alberto Tebar, Luis
    Rodriguez-Rodriguez, Luis
    BMJ OPEN, 2022, 12 (03):