Completed

Safety and Pharmacokinetics of Valganciclovir Syrup Formulation in Pediatric Solid Organ Transplant Recipients

What is being tested

valganciclovir [Valcyte]

Drug

Who is being recruted

Cytomegalovirus Infections+2

+ DNA Virus Infections

+ Herpesviridae Infections

From 3 Months to 16 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2 & 3

Interventional

Study Start: May 2004

See protocol details

Summary

Principal SponsorHoffmann-La Roche

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.

Official TitleSafety and Pharmacokinetics of Valganciclovir Syrup Formulation in Pediatric Solid Organ Transplant Recipients

NCT00090766

Principal SponsorHoffmann-La Roche

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

63 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 Months to 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cytomegalovirus InfectionsDNA Virus InfectionsHerpesviridae InfectionsInfectionsVirus Diseases

Criteria

5 inclusion criteria required to participate

patients between 3 months and 16 years of age;

first solid organ transplant (eg, kidney, liver, heart);

able to tolerate oral medication;

females of childbearing potential must agree to utilize an effective method of contraception throughout the study and for 90 days following discontinuation of study drug;

Show More Criteria

4 exclusion criteria prevent from participating

patients who have previously participated in this study;

patients who are participating in another clinical trial (except with the approval of the Sponsor);

severe, uncontrolled diarrhea (more than 5 watery stools per day);

pregnant or lactating females.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 \* body surface area (BSA) \* creatinine clearance (CrCLS).

Group II

Experimental

Eligible participants aged \>2 to \<12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 \* BSA \* CrCLS.

Group III

Experimental

Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 \* BSA \* CrCLS.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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CompletedNo study centers