Last updated on October 2016

hATG+CsA vs hATG+CsA+Eltrombopag for SAA


Brief description of study

The null hypothesis of no difference in CR% at 3 months between the arms will be tested against the alternative of a difference in CR% at an alpha level of .05 by assessing the odds ratio for arm yielded by this model.

Detailed Study Description

This is a superiority trial aiming to increase the 3 month complete response rate. The sample size is calculated on the hypothesis that the experimental treatment will increase the 3 months response rate up to 21% (by 3 folds, based on the 7% reported in Scheinberg et al [17]). Under these assumptions, the sample size to reject the null hypothesis is n=96 patients for each treatment arm, increased by 4% for possibly not evaluable patients (total number of 200 patients, 100 each treatment arm). Statistical design for sample size calculation: increase from 7% (control arm) to 21% (investigational arm) in 3 month complete response rate (two-sided binomial test); alpha-error 0.05; power 0.8.

Clinical Study Identifier: NCT02099747

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Eric Deconinck, Prof, MD

Hopital Jean Minjoz
Besancon, France
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Reza Tabrizi, MD, PhD

H pital Haut-L v que
Bordeaux, France
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Alain Barrois, MSc

H pital Huriez
Lille, France
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Fiorenza Barraco, MD

Centre Hospitalier Lyon-Sud
Lyon, France
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Regis Peffault de la Tour, ...

St. Louis Hospital
Paris, France
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Christian Recher, Prof, MD.

H pital Purpan
Toulouse, France
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Tim Brümmendorf, Prof, MD

Uniklinik RWTH Aachen
Aachen, Germany
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Alexander Röth, MD, PhD

Universitatsklinikum Essen
Essen, Germany
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Philippe Schafhausen, MD

Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany
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Arnold Ganser, Prof, MD

Hannover Medical School
Hannover, Germany
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Richard Schlenk, MD

University of Ulm
Ulm, Germany
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Alessandro Rambaldi, Prof, MD

Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
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Alain Barrois, MSc

Istituto G. Gaslini children's Hospital
Genova, Italy
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Maria-Theresa van Lint, MD

San Martino Hospital
Genova, Italy
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Wilma Barcelini, MD

Fondazione IRCCS ca Granda Ospedale
Milan, Italy
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Antonio Risitano, MD, PhD

`Federico II` Medical School
Napels, Italy
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Roberto Foa, Prof, MD

La Sapienza University Hospital
Rome, Italy
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Sacha Zeerleder, MD, PhD

AMC
Amsterdam, Netherlands
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Alain Barrois, MSc

UMCG
Groningen, Netherlands
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Stijn Halkes, MD, PhD

Leiden University Medical Center
Leiden, Netherlands
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Alain Barrois, MSc

UMCU
Utrecht, Netherlands
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Blanca Xicoy, MD

Hospital Universitari Germans Trias I Pujol
Badalona, Spain
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Marta Polo Zarzuela, MD

Hospital Clinico San Carlos
Madrid, Spain
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Ana Rosell Mas, MD

Hospital Virgen de la Victoria
Malaga, Spain
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Alain Barrois, MSc

Donostia Hospital
San Sebastian, Spain
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Isidro Jarque Ramos, MD, PhD

Hospital La Fe
Valencia, Spain
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Dominik Heim, MD, PhD

University Hospital Basel
Basel, Switzerland
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Damian Finnegan, MD, PhD

City Hospital
Belfast, United Kingdom
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Anita Hill, MD, PhD

St. James Hospital
Leeds, United Kingdom
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Judith Marsh, Prof, MD

King's College Hospital
London, United Kingdom
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Alain Barrois, MSc

St. Bartholomew's Hospital
London, United Kingdom
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Alain Barrois, MSc

City Hospital
Nottingham, United Kingdom
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