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

Allogeneic Stem Cell Transplantation Clinical Trial

— CONVINCE  

Official title:

Multicenter, Randomized Study Comparing Oral Valganciclovir Versus Intravenous Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01185223
• Other study ID #: ML 22371
• Status: Terminated
• Phase: Phase 3
• First received: August 18, 2010
• Last updated: December 7, 2012
• Start date: September 2010

Study information

• Verified date: December 2012
• Source: Pierrel Research Europe GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Agency for Health and Food SafetyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 212
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allogeneic Stem Cell Transplantation

Intervention

Drug:
• Valganciclovir
Valganciclovir 450mg tablet or Valganciclovir powder for oral solution 50mg/mL
• Ganciclovir
2x5mg/kg/d intravenous ganciclovir

Locations

Country	Name	City	State
Austria	Pierrel Site 50	Vienna
Germany	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
Spain	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

Sponsors (2)

Lead Sponsor	Collaborator
Pierrel Research Europe GmbH	Roche Pharma AG

Countries where clinical trial is conducted

Austria,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir	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.	max. 2 years (recruitement time)	Yes
Secondary	Combined secondary endpoint of efficacy and safety	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.	max. 2 years (recruitement time)	Yes