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Trial record 11 of 101 for:    Valcyte

Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation (CONVINCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01185223
Recruitment Status : Terminated
First Posted : August 19, 2010
Last Update Posted : December 10, 2012
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Pierrel Research Europe GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Allogeneic Stem Cell Transplantation Drug: Valganciclovir Drug: Ganciclovir Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multicenter, Randomized Study Comparing Oral Valganciclovir Versus Intravenous Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
Study Start Date : September 2010
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Valganciclovir Drug: Valganciclovir
Valganciclovir 450mg tablet or Valganciclovir powder for oral solution 50mg/mL
Other Names:
  • Ro 107-9070
  • Valcyte

Active Comparator: Ganciclovir Drug: Ganciclovir
2x5mg/kg/d intravenous ganciclovir
Other Name: Cymeven




Primary Outcome Measures :
  1. Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir [ Time Frame: max. 2 years (recruitement time) ]

    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.



Secondary Outcome Measures :
  1. Combined secondary endpoint of efficacy and safety [ Time Frame: max. 2 years (recruitement time) ]

    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient following allogeneic SCT
  • 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 a suspected or diagnosed CMV disease
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185223


Locations
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Austria
Pierrel Site 50
Vienna, Austria
Germany
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
Spain
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
Sponsors and Collaborators
Pierrel Research Europe GmbH
Roche Pharma AG
Investigators
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Principal Investigator: Hermann Einsele, Prof. Dr. Hospital

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Responsible Party: Pierrel Research Europe GmbH
ClinicalTrials.gov Identifier: NCT01185223     History of Changes
Other Study ID Numbers: ML 22371
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 2012

Keywords provided by Pierrel Research Europe GmbH:
Valganciclovir
Ganciclovir
Antiviral Drug
CMV disease

Additional relevant MeSH terms:
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Ganciclovir
Valganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action