Roche trials database

Trial information

A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients less than 4 Months of Age

Status:

Recruiting

Protocol number:

NP22523

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

Pharmacokinetics and Safety of valganciclovir in pediatric heart transplant recipients < 4 months of age

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. Target sample size is 16.

Study phase:

I

Study type:

Interventional; Prevention; Non-randomized; Open label; Single group; Pharmacokinetics study

Conditions:

• Cytomegalovirus Infections
• Heart Transplantation

Primary outcome:

1. Area under plasma concentration versus time curve of ganciclovir Time frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose
2. Apparent volume of distribution of ganciclovir Time frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose
3. Terminal half-life of ganciclovir Time frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose
4. Peak concentration of ganciclovir Time frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose

Key secondary outcomes:

1. Safety (Incidence of adverse events) Time frame: 9 days

Inclusion criteria:

• 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)

Exclusion criteria:

• 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

Gender:

Males or Females

Age limits:

Min: N/A Max: 124 days

Accepts healthy volunteers:

No

Anticipated start date:

May, 2011

Trial registration date:

09.07.2010

Date last updated:

04.06.2013

This trial is being conducted at the following locations:

CANADA

• Edmonton, Alber

SPAIN

• Madrid, MADRI

U.S.A.

• ATLANTA, GA

UNITED STATES

• Loma Linda, CA
• Palo Alto, CA
• Aurora, CO
• Ann Arbor, MI
• Detroit, MI
• Saint Louis, MO
• Durham, NC
• Bronx, NY
• Cincinnati, OH
• Cleveland, OH
• Charleston, SC
• Nashville, TN
• DALLAS, TX
• Seattle, WA
• Milwaukee, WI

Link to trial result