Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierrel Research Europe GmbH
• Collaborator: Roche Pharma AG
• Treatments: Ganciclovir; Ganciclovir triphosphate; Valganciclovir

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