Status:
TERMINATED
Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
Lead Sponsor:
Pierrel Research Europe GmbH
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Allogeneic Stem Cell Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT01185223
Start Date
September 1 2010
Last Update
December 10 2012
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Pierrel Site 50
Vienna, Austria
2
Pierrel Site 12
Berlin, Germany
3
Pierrel Site 13
Berlin, Germany
4
Pierrel Site 9
Bremen, Germany