Clinical trial NCT01185223: Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
Official title: Multicenter, Randomized Study Comparing Oral Valganciclovir Versus Intravenous Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Allogeneic Stem Cell Transplantation
Keywords: Valganciclovir
Ganciclovir
Antiviral Drug
CMV disease
Lead sponsor: Pierrel Research Europe GmbH
Sponsor class: INDUSTRY
Collaborators: name: Roche Pharma AG
First posted: 2010-08-19
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir
timeFrame: max. 2 years (recruitement time)
Secondary outcomes:
measure: Combined secondary endpoint of efficacy and safety
timeFrame: max. 2 years (recruitement time)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Pierrel Site 50
city: Berlin
country: Germany
facility: Pierrel Site 12
city: Berlin
country: Germany
facility: Pierrel Site 13
city: Bremen
country: Germany
facility: Pierrel Site 9
city: Essen
country: Germany
facility: Pierrel Site 3
city: Kiel
country: Germany
facility: Pierrel Site 7
city: Leipzig
country: Germany
facility: Pierrel Site 5
city: Münster
country: Germany
facility: Pierrel Site 4
city: Oldenburg
country: Germany
facility: Pierrel Site 8
city: Rostock
country: Germany
facility: Pierrel Site 10
city: Würzburg
country: Germany
facility: Pierrel Site 1
city: Barcelona
country: Spain
facility: Pierrel Site 32
city: Barcelona
country: Spain
facility: Pierrel Site33
city: Madrid
country: Spain
facility: Pierrel Site 30
city: Madrid
country: Spain
facility: Pierrel Site 34
city: Salamanca
country: Spain
facility: Pierrel Site 31
city: Valencia
country: Spain
facility: Pierrel Site 35
Study officials:
affiliation: Hospital
name: Hermann Einsele, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: