NCT01185223

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
3 countries

17 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

December 10, 2012

Status Verified

December 1, 2012

Enrollment Period

2.3 years

First QC Date

August 18, 2010

Last Update Submit

December 7, 2012

Conditions

Allogeneic Stem Cell Transplantation

Keywords

ValganciclovirGanciclovirAntiviral DrugCMV disease

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Combined secondary endpoint of efficacy and safety

    max. 2 years (recruitement time)

Study Arms (2)

Valganciclovir

OTHER
Drug: Valganciclovir

Ganciclovir

ACTIVE COMPARATOR
Drug: Ganciclovir

Interventions

ValganciclovirDRUG

Valganciclovir 450mg tablet or Valganciclovir powder for oral solution 50mg/mL

Also known as: Ro 107-9070, Valcyte
Valganciclovir
GanciclovirDRUG

2x5mg/kg/d intravenous ganciclovir

Also known as: Cymeven
Ganciclovir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Pierrel Site 50

Vienna, Austria

Location

Pierrel Site 12

Berlin, Germany

Location

Pierrel Site 13

Berlin, Germany

Location

Pierrel Site 9

Bremen, Germany

Location

Pierrel Site 3

Essen, Germany

Location

Pierrel Site 7

Kiel, Germany

Location

Pierrel Site 5

Leipzig, Germany

Location

Pierrel Site 4

Münster, Germany

Location

Pierrel Site 8

Oldenburg, Germany

Location

Pierrel Site 10

Rostock, Germany

Location

Pierrel Site 1

Würzburg, Germany

Location

Pierrel Site 32

Barcelona, Spain

Location

Pierrel Site33

Barcelona, Spain

Location

Pierrel Site 30

Madrid, Spain

Location

Pierrel Site 34

Madrid, Spain

Location

Pierrel Site 31

Salamanca, Spain

Location

Pierrel Site 35

Valencia, Spain

Location

MeSH Terms

Conditions

Multiple Acyl Coenzyme A Dehydrogenase Deficiency

Interventions

ValganciclovirGanciclovir

Condition Hierarchy (Ancestors)

Amino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesMitochondrial Diseases

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Hermann Einsele, Prof. Dr.

    Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 18, 2010

First Posted

August 19, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2012

Last Updated

December 10, 2012

Record last verified: 2012-12

Locations

AU(1)DE(10)ES(6)