Trials Sponsors Conditions Drugs Pricing

Conditions

Cytomegalovirus Viraemia

Keywords

Quantiferon-CMVQuantiferon-MonitorSolid Organ TransplantsCMV Disease

Outcome Measures

Primary Outcomes (1)

Virologic recurrence or disease recurrence
6 months

Study Arms (2)

Low CMV CMI

ACTIVE COMPARATOR

Patients that show low levels of cell-mediated immunity against CMV will have their antiviral therapy (oral Valganciclovir or Intravenous Ganciclovir) continued for an additional 2 months at half dose.

Drug: Valganciclovir or Ganciclovir

High CMV CMI

NO INTERVENTION

Patients that show high levels of cell-mediated immunity against CMV will have their antiviral therapy (oral Valganciclovir or Intravenous Ganciclovir) stopped.

Interventions

Valganciclovir or GanciclovirDrug

Low CMV CMI

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Adult solid organ transplant (SOT) recipient on at least one immunosuppressive medication
Starting therapy for new onset asymptomatic CMV viremia OR starting therapy for new onset CMV disease

Sponsors & Collaborators

University Health Network, Toronto
Otherlead

Study Sites (1)

University Health Network, Toronto General Hospital, Multi-Organ Transplant

Toronto, Ontario, M5G2N2, Canada

MeSH Terms

Interventions

ValganciclovirGanciclovir

Intervention Hierarchy (Ancestors)

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

Study Officials

Atul Humar, MD
University Health Network, Toronto
PRINCIPAL INVESTIGATOR
Deepali Kumar, MD
University Health Network, Toronto
PRINCIPAL INVESTIGATOR

Enrollment

32 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 18, 2015

First Posted

February 25, 2015

Study Start

November 2014

Actual (reported)

Cell Mediated Immunity for Secondary Prophylaxis in CMV SOT Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Low CMV CMI

High CMV CMI

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Low CMV CMI

High CMV CMI

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations