NCT00377741

Brief Summary

This study will assess the relative bioavailability of ganciclovir from the pro-drug valganciclovir in lung transplant recipients with or without cystic fibrosis. Each patient will receive 900mg valganciclovir daily for the period specified at their center, starting as soon as possible after the transplant. Pharmacokinetic assessments will be made provided that steady-state kinetics of ganciclovir and immunosuppressive drugs have been obtained (\>=4 days of drug therapy). Blood samples for pharmacokinetic analysis will be taken up to 24h post-dose on one occasion. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2004

Geographic Reach
1 country

5 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

Study Start

First participant enrolled

December 1, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2006

Completed
9.3 years until next milestone

Results Posted

Study results publicly available

December 31, 2015

Completed
Last Updated

December 31, 2015

Status Verified

November 1, 2015

Enrollment Period

1.5 years

First QC Date

September 15, 2006

Results QC Date

November 26, 2015

Last Update Submit

November 26, 2015

Conditions

Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (2)

  • Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau)

    The area under the plasma concentration-time curve from time zero to end of dosing interval (AUC \[0-tau\]) is a measure of the plasma ganciclovir concentration from time zero to end of dosing interval. It was computed using the linear trapezoidal rule. The pharmacokinetic parameters of valganciclovir were measured in plasma of all participants following a single oral dose valganciclovir at 900 mg on Day 1.

    Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose

  • Maximum Observed Plasma Concentration (Cmax) of Ganciclovir

    The Cmax is defined as maximum observed Ganciclovir concentration. Cmax of valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.

    Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose

Secondary Outcomes (3)

  • Time to Maximum Observed Plasma Concentration (Tmax) of Ganciclovir

    Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose

  • Apparent Elimination Rate (Kelim) of Ganciclovir

    Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose

  • Plasma Half-Life (T1/2) of Ganciclovir

    Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose

Study Arms (1)

1

EXPERIMENTAL
Drug: valganciclovir [Valcyte]

Interventions

valganciclovir [Valcyte]DRUG

900mg po

1

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • male or female patients, \>=14 years of age;
  • first lung or heart-lung transplant recipient;
  • at risk of CMV disease (D+R-,D+R+ or D-R+);
  • estimated creatinine clearance \>=60mL/min;
  • stable immunosuppressive and 900mg Valcyte dosing regimens (\>=4 days) prior to pharmacokinetic assessments.

You may not qualify if:

  • history of any adverse reaction to acyclovir, valacyclovir, ganciclovir or valganciclovir;
  • evidence of graft rejection;
  • patient has received anti-CMV prophylaxis with a treatment other than cytogam, ganciclovir or valganciclovir between transplant and screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Los Angeles, California, 90033, United States

Location

Unknown Facility

Denver, Colorado, 80262, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15213, United States

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

Results Point of Contact

Title
Roche Trial Information Hotline
Organization
F. Hoffmann-La Roche AG
global.trial_information@roche.com
+41 616878333

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2006

First Posted

September 18, 2006

Study Start

December 1, 2004

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

December 31, 2015

Results First Posted

December 31, 2015

Record last verified: 2015-11

Locations

US(5)