Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
Information source: Pierrel Research Europe GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allogeneic Stem Cell Transplantation
Intervention: Valganciclovir (Drug); Ganciclovir (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Pierrel Research Europe GmbH Official(s) and/or principal investigator(s):
Hermann Einsele, Prof. Dr., Principal Investigator, Affiliation: Hospital
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.
Clinical Details
Official title: Multicenter, Randomized Study Comparing Oral Valganciclovir Versus Intravenous Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir
Secondary outcome: Combined secondary endpoint of efficacy and safety
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
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
Additional Information
Starting date: September 2010
Last updated: December 7, 2012
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