Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
- Conditions
- Allogeneic Stem Cell Transplantation
- Interventions
- Registration Number
- NCT01185223
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 212
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ganciclovir Ganciclovir - Valganciclovir Valganciclovir -
- Primary Outcome Measures
Name Time Method Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir 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
Name Time Method Combined secondary endpoint of efficacy and safety 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.
Trial Locations
- Locations (17)
Pierrel Site 50
🇦🇹Vienna, Austria
Pierrel Site 12
🇩🇪Berlin, Germany
Pierrel Site 13
🇩🇪Berlin, Germany
Pierrel Site 4
🇩🇪Münster, Germany
Pierrel Site 30
🇪🇸Madrid, Spain
Pierrel Site 35
🇪🇸Valencia, Spain
Pierrel Site 5
🇩🇪Leipzig, Germany
Pierrel Site 34
🇪🇸Madrid, Spain
Pierrel Site 8
🇩🇪Oldenburg, Germany
Pierrel Site 32
🇪🇸Barcelona, Spain
Pierrel Site33
🇪🇸Barcelona, Spain
Pierrel Site 3
🇩🇪Essen, Germany
Pierrel Site 1
🇩🇪Würzburg, Germany
Pierrel Site 31
🇪🇸Salamanca, Spain
Pierrel Site 7
🇩🇪Kiel, Germany
Pierrel Site 9
🇩🇪Bremen, Germany
Pierrel Site 10
🇩🇪Rostock, Germany