Gastroenterology
Volume 134, Issue 5 , Pages 1360-1368 , May 2008

A Randomized, Prospective, Double-Blind, Placebo-Controlled Trial of Terlipressin for Type 1 Hepatorenal Syndrome

  • Arun J. Sanyal

      Affiliations

    • Division of Gastroenterology, Hepatology and Nutrition, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia
    • Corresponding Author InformationAddress requests for reprints to: Arun J. Sanyal, MD, Professor of Medicine, Pharmacology and Pathology, MCV Box 980341, Richmond, Virginia 23298-0341. fax: (804) 828 2992.
    • ,
  • Thomas Boyer

      Affiliations

    • Liver Research Institute, Department of Internal Medicine, University of Arizona, College of Medicine, Tucson, Arizona
    • ,
  • Guadalupe Garcia–Tsao

      Affiliations

    • Digestive Diseases Section, Department of Internal Medicine, Yale University and VA CT Healthcare System, New Haven, Connecticut
    • ,
  • Frederick Regenstein

      Affiliations

    • Division of Gastroenterology, Department of Internal Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana
    • ,
  • Lorenzo Rossaro

      Affiliations

    • Division of Gastroenterology and Hepatology, Department of Internal Medicine, UC Davis Medical Center, Sacramento, California
    • ,
  • Beate Appenrodt

      Affiliations

    • Department of Medicine I, University of Bonn, Bonn, Germany
    • ,
  • Andres Blei

      Affiliations

    • Division of Hepatology, Northwestern University, Chicago, Illinois
    • ,
  • Veit Gülberg

      Affiliations

    • Department of Medicine II, Klinikum Grosshadern, Ludwig-Maximilians University of Munich, Germany
    • ,
  • Samuel Sigal

      Affiliations

    • Weill Cornell Medical Center and Columbia University Medical Center, New York, New York
    • ,
  • Peter Teuber

      Affiliations

    • Orphan Therapeutics, LLC, Lebanon, New Jersey
    • ,
  • The Terlipressin Study Group

Received 27 August 2007 ,Accepted 7 February 2008.

References 

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 Supported in part by a grant from the FDA (Office of Orphan Products Grant 1R01FD003024-01) and in part by Orphan Therapeutics.

 This is original work and is not under consideration for publication elsewhere. This work has been presented in part at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston in November 2006. The study was registered at www.clinicaltrials.gov (ClinicalTrials.gov identifier NCT00089570).

 A.J.S. and T.B. contributed equally to the writing of the manuscript.

 Conflicts of interest and financial disclosures: Arun J. Sanyal, MBBS, MD: Stipends paid by Orphan Therapeutics to maintain the 24-hour study Medical Hotline (June 2004, $12,000; May 2005, $12,000). Reimbursement for travel costs and data reviews for FDA meetings (2006, $501.90; April 2007, $251.67). Thomas Boyer, MD: Reimbursement for travel costs and data reviews for FDA meetings (February 2004, $1157.90; June 2006, $377.70; October 2006, $699.20; March 2007, $389.60). Honorarium for OT-0401 Steering Committee in 2004 ($1350.00). Guadalupe Garcia-Tsao, MD: Honorarium for OT-0401 Steering Committee in 2004 ($750.00). Frederick Regenstein, MD: Honorarium for OT-0401 Steering Committee in 2004 ($750.00). Lorenzo Rossaro, MD: Honorarium for OT-0401 Steering Committee in 2004 ($750.00). Andres Blei, MD: None. Veit Gülberg, MD: None. Beate Appenrodt, MD: None. Samuel Sigal, MD: None. Peter Teuber, PhD: President and Managing Partner of Orphan Therapeutics, LLC (OT-0401 study cosponsor).

PII: S0016-5085(08)00245-X

doi: 10.1053/j.gastro.2008.02.014

Gastroenterology
Volume 134, Issue 5 , Pages 1360-1368 , May 2008

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