A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients

Roche

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cytomegalovirus Infections

Treatments: Drug: valganciclovir [Valcyte]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00090766

WV16726

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 3 months to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;
• patients at risk of developing CMV disease (all transplant recipients other than those who are D-R- for CMV).

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 3 patient groups

Valganciclovir Age Group <= 2 Years

Experimental group

Description:

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).

Treatment:

Drug: valganciclovir [Valcyte]

Valganciclovir Age Group >2 to <12 Years

Experimental group

Description:

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.

Treatment:

Drug: valganciclovir [Valcyte]

Valganciclovir Age Group >= 12 Years

Experimental group

Description:

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.

Treatment:

Drug: valganciclovir [Valcyte]