NCT01165580

Brief Summary

This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients \< 4 months of age.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2011

Typical duration for phase_1

Geographic Reach
3 countries

19 active sites

Status
completed

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

July 16, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2010

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

July 16, 2010

Last Update Submit

November 1, 2016

Conditions

Cytomegalovirus Infections, Heart Transplantation

Outcome Measures

Primary Outcomes (4)

  • Area under plasma concentration versus time curve of ganciclovir

    0, 1-3, 3-7, 7-12, 24 hours post-dose

  • Apparent volume of distribution of ganciclovir

    0, 1-3, 3-7, 7-12, 24 hours post-dose

  • Terminal half-life of ganciclovir

    0, 1-3, 3-7, 7-12, 24 hours post-dose

  • Peak concentration of ganciclovir

    0, 1-3, 3-7, 7-12, 24 hours post-dose

Secondary Outcomes (1)

  • Safety (Incidence of adverse events)

    9 days

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: valganciclovir [Valcyte]

Interventions

valganciclovir [Valcyte]DRUG

oral dose, Days 1 and 2

Single Arm

Eligibility Criteria

AgeUp to 124 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Males and females, 0 to \< 4 months (\< 125 days) of age at the time of the last PK assessment in this study
  • Parent or guardian of the patient is willing and able to give written informed consent
  • Patient has received a first heart transplant
  • Patient is at risk of developing cytomegalovirus (CMV) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of CMV
  • Adequate hematological and renal function
  • Able to tolerate oral medication (any appropriate form of tube feeding is acceptable)

You may not qualify if:

  • Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
  • Severe, uncontrolled, clinically abnormal diarrhea
  • Liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT)
  • Patient requires use of any protocol prohibited concomitant medications
  • Patient has previously participated in this clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Loma Linda, California, 92354, United States

Location

Unknown Facility

Palo Alto, California, 94304, United States

Location

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Ann Arbor, Michigan, 48109, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

The Bronx, New York, 10467, United States

Location

Unknown Facility

Durham, North Carolina, 22710, United States

Location

Unknown Facility

Cincinnati, Ohio, 45229, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Charleston, South Carolina, 29425, United States

Location

Unknown Facility

Nashville, Tennessee, 37232-9119, United States

Location

Unknown Facility

Dallas, Texas, 75390, United States

Location

Unknown Facility

Seattle, Washington, 98105, United States

Location

Unknown Facility

Milwaukee, Wisconsin, 53226, United States

Location

Unknown Facility

Edmonton, Alberta, T6G 1C9, Canada

Location

Unknown Facility

Madrid, Madrid, 28007, Spain

Location

Unknown Facility

Madrid, Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

GanciclovirAcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2010

First Posted

July 20, 2010

Study Start

May 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

CA(1)ES(2)US(16)