Cytomegalovirus Infections, Heart Transplantation Clinical Trial
Official title:
Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients < 4 Months of Age
| Verified date | November 2016 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 17 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 124 Days |
| Eligibility |
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 |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States, Canada, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Area under plasma concentration versus time curve of ganciclovir | 0, 1-3, 3-7, 7-12, 24 hours post-dose | No | |
| Primary | Apparent volume of distribution of ganciclovir | 0, 1-3, 3-7, 7-12, 24 hours post-dose | No | |
| Primary | Terminal half-life of ganciclovir | 0, 1-3, 3-7, 7-12, 24 hours post-dose | No | |
| Primary | Peak concentration of ganciclovir | 0, 1-3, 3-7, 7-12, 24 hours post-dose | No | |
| Secondary | Safety (Incidence of adverse events) | 9 days | No |