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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01185223
Other study ID # ML 22371
Secondary ID
Status Terminated
Phase Phase 3
First received August 18, 2010
Last updated December 7, 2012
Start date September 2010

Study information

Verified date December 2012
Source Pierrel Research Europe GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesAustria: Agency for Health and Food SafetyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Interventional

Clinical Trial Summary

The objective of this study is to assess the efficacy and safety of oral valganciclovir versus intravenous ganciclovir in patients following allogenic stem cell transplantation.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms

  • Allogeneic Stem Cell Transplantation

Intervention

Drug:
Valganciclovir
Valganciclovir 450mg tablet or Valganciclovir powder for oral solution 50mg/mL
Ganciclovir
2x5mg/kg/d intravenous ganciclovir

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Sponsors (2)

Lead Sponsor Collaborator
Pierrel Research Europe GmbH Roche Pharma AG

Countries where clinical trial is conducted

Austria,  Germany,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir Main variable for efficacy in the primary endpoint will be evaluated by assessment of the event-free survival within 180 days after stem cell transplantation.
Main variable for safety in the primary endpoint will be evaluated by the porpotion of patients with severe neutropenia until 7 days after discontinuation of antiviral therapy with the study drug.
max. 2 years (recruitement time) Yes
Secondary Combined secondary endpoint of efficacy and safety The secondary variables of efficacy will be:
The proportion of patients with persistently positive blood specimens for CMV after completion of antiviral therapy with the Study Drug,
The proportion of patients who require retreatment after discontinuation of antiviral therapy with the Study Drug until day 180,
The proportion of patients with CMV disease within 180 days after SCT,
The number of days patients were alive and not hospitalized between randomization and day 180 post SCT,
The proportion of patients who died from any cause within 180 days after SCT.
max. 2 years (recruitement time) Yes
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