Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
NCT ID: NCT01185223
Last Updated: 2012-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
212 participants
INTERVENTIONAL
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Valganciclovir
Valganciclovir
Valganciclovir 450mg tablet or Valganciclovir powder for oral solution 50mg/mL
Ganciclovir
Ganciclovir
2x5mg/kg/d intravenous ganciclovir
Interventions
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Valganciclovir
Valganciclovir 450mg tablet or Valganciclovir powder for oral solution 50mg/mL
Ganciclovir
2x5mg/kg/d intravenous ganciclovir
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after SCT
* Absolute neutrophil count (ANC) ≥1000 cells/µL on 2 consecutive follow-ups within 10 days before randomization
* Patient has a creatinine clearance of ≥25 mL/min (calculated by the Cockcroft-Gault formula, see Part I Section 6.1.2) with evidence of improving renal function,
* None or gastrointestinal graft-versus-host disease (GVHD) up to grade 2
Exclusion Criteria
* Patient has received syngeneic SCT
* Patient who received an investigational medicinal product (IMP) within the last 30 days prior to screening or who is simultaneously participating in another clinical study with an IMP
* Patient with a body weight \<50 kg or \>95 kg,
* Patient has received anti-CMV therapy within the past 30 days prior to screening (the use of acyclovir, valacyclovir, or famciclovir is permitted)
* Patient who has participated in this study before,
* Patient who shows a neutropenia, thrombocytopenia, or anemia within 10 days before or at the time point of randomization as following:
* The ANC is \<1000 cells/μL on 2 consecutive follow-ups, or
* A platelet count of ≥25000/μL can not be achieved/maintained with platelet transfusions
* A hemoglobin level of ≥8g/dL can not be achieved/maintained by red blood cell transfusions
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Pierrel Research Europe GmbH
INDUSTRY
Responsible Party
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Pierrel Research Europe GmbH
Principal Investigators
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Hermann Einsele, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital
Locations
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Pierrel Site 50
Vienna, , Austria
Pierrel Site 12
Berlin, , Germany
Pierrel Site 13
Berlin, , Germany
Pierrel Site 9
Bremen, , Germany
Pierrel Site 3
Essen, , Germany
Pierrel Site 7
Kiel, , Germany
Pierrel Site 5
Leipzig, , Germany
Pierrel Site 4
Münster, , Germany
Pierrel Site 8
Oldenburg, , Germany
Pierrel Site 10
Rostock, , Germany
Pierrel Site 1
Würzburg, , Germany
Pierrel Site 32
Barcelona, , Spain
Pierrel Site33
Barcelona, , Spain
Pierrel Site 30
Madrid, , Spain
Pierrel Site 34
Madrid, , Spain
Pierrel Site 31
Salamanca, , Spain
Pierrel Site 35
Valencia, , Spain
Countries
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Other Identifiers
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ML 22371
Identifier Type: -
Identifier Source: org_study_id