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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- A hemoglobin level of ≥8g/dL can not be achieved/maintained by red blood cell


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

Page last updated: August 23, 2015

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