CompletedPhase 1

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

United States, Canada, Spain17 participantsStarted 2011-05

Plain-language 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.

Who can participate

Age range

124 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under plasma concentration versus time curve of ganciclovir

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

Apparent volume of distribution of ganciclovir

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

Terminal half-life of ganciclovir

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

Peak concentration of ganciclovir

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

Trial details

NCT IDNCT01165580

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-09

View on ClinicalTrials.gov More Cytomegalovirus Infections, Heart Transplantation trials

Who can participate

Age range

124 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Area under plasma concentration versus time curve of ganciclovir

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

Apparent volume of distribution of ganciclovir

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

Terminal half-life of ganciclovir

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

Peak concentration of ganciclovir

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