Assessment of valganciclovir in neonates with CMV - Article
Clinical Trial: Assessment of valganciclovir in neonates with CMV
This study is currently recruiting patients.
o To evaluate the safety and tolerability of valganciclovir syrup in the neonatal and infantile populations
|Condition||Treatment or Intervention||Phase|
|Cytomegalovirus Infections || Drug: Ganciclovir |
Drug: Valganciclovir (Oral)
|Phase I |
MedlinePlus related topics: Cytomegalovirus Infections
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Uncontrolled, Factorial Assignment
Official Title: A Phase I/II Pharmacokinetic and Pharmacodynamic Evaluation of Oral Valganciclovir in Neonates with Symptomatic Congenital Cytomegalovirus (CMV) Infection Involving the Central Nervous System (CASG 109)
Expected Total Enrollment: 24
Study start: July 2002
Recent trials have demonstrated that ganciclovir treatment of neonates with symptomatic congenital CMV disease involving the CNS results in improved hearing function (or maintenance of normal hearing function) and prevents hearing deterioration at 6 months. Furthermore, ganciclovir therapy may prevent hearing deterioration at 1 year. Ganciclovir recipients also have a more rapid resolution of their transaminase elevations and a greater degree of short term growth in weight and head circumference compared with untreated patients.
Ganciclovir therapy must be administered intravenously and often requires the establishment of a central line in these babies. Valganciclovir, the oral prodrug of ganciclovir, has been developed as a syrup formulation and presents the opportunity to treat longer without the requirement for a central line, but pharmacokinetic data are needed in infants first to assure the correct dose is being utilized.
This Phase I/II, multi-center, open-label trial will assess the safety/tolerability and pharmacokinetics (ganciclovir concentrations) following administration of oral valganciclovir to neonates with symptomatic congenital CMV disease. A total of 24 patients will be evaluated.
The primary endpoint is pharmacokinetics of ganciclovir following administration of oral valganciclovir syrup. The pharmacokinetics will be assessed by a population approach to PK data analysis. Secondary endpoints are: the pharmacokinetics of valganciclovir following administration of oral valganciclovir; the correlation of ganciclovir plasma concentrations following intravenous ganciclovir or oral valganciclovir syrup with CMV whole blood viral load; the incidence of emesis following oral valganciclovir administration (tolerability); safety as assessed by neutropenia incidence
Ages Eligible for Study: up to 1 Month, Genders Eligible for Study: Both
- Signed informed consent from parent(s) or legal guardian(s).
- Culture confirmation of cytomegalovirus from urine or throat swab specimens.
- Less than or equal to 30 days of age at study enrollment.
- Weight at study enrollment > or equal to 1800 grams
- Gestational age greater than or equal to 32 weeks.
Symptomatic congenital CMV disease, as manifest by one or more of the following:
- Intrauterine growth restriction
- Hepatitis (elevated transaminases and/or bilirubin
- Central nervous system involvement of the CMV disease (such as microcephaly, radiographic abnormalities indicative of CMV CNS disease, abnormal CSF indices for age, chorioretinitis, hearing deficits as detected by brainstem evoked response, and/or positive CMV PCR from CSF)
- Imminent demise.
- Patients receiving other antiviral agents or immune globulin.
- Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis).
- Creatinine clearance less than 10 mL/min at time of study enrollment.
- Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry).
Location and Contact Information
University of Alabama at Birmingham (CASG), Birmingham, Alabama, 35294, United States; Recruiting
Arkansas Children's Hospital, Little Rock, Arkansas, 72202, United States; Recruiting
Stanford University, Stanford, California, 94305-52, United States; Recruiting
Children's Hospital of Orange County, Orange, California, 92868, United States; Recruiting
University of Florida HSC - Jacksonville, Jacksonville, Florida, 32209, United States; Recruiting
University of Kansas, Kansas City, Kansas, 66160, United States; Recruiting
Via Christi Regional Medical Center, Wichita, Kansas, 67214, United States; Recruiting
University of Louisville Health Sciences Center, Louisville, Kentucky, 40292, United States; Recruiting
Tulane University Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Johns Hopkins University, Baltimore, Maryland, 21287-25, United States; Recruiting
St. Louis University, St. Louis, Missouri, 63104, United States; Recruiting
Washington University, St. Louis, Missouri, 63110, United States; Recruiting
Creighton University, Omaha, Nebraska, 68178, United States; Recruiting
State University New York Stony Brook, Stony Brook, New York, 11794, United States; Recruiting
SUNY Upstate Medical University, Syracuse, New York, 13210, United States; Recruiting
North Shore - Long Island Jewish Health System, Manhasset, New York, 11030, United States; Recruiting
MetroHealth Medical Center of Cleveland, Cleveland, Ohio, 44109, United States; Recruiting
Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States; Recruiting
University of Texas Hlth Sci Ctr San Ant, San Antonio, Texas, 78284-78, United States; Recruiting
Cook - Fort Worth Children's Medical Center, Fort Worth, Texas, 76104, United States; Recruiting
University of Texas Southwestern Medical Center, Dallas, Texas, 75235, United States; Recruiting
University of Alberta, Edmonton, Alberta, T6G2B7, Canada; Recruiting
University of Manitoba - Winnipeg, Winnipeg, Manitoba, R3T 2N2, Canada; Recruiting
Record last reviewed: November 2004
Last Updated: December 29, 2004
Record first received: March 6, 2002
ClinicalTrials.gov Identifier: NCT00031434
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005
- Birds, Infections from (Centers for Disease Control and Prevention)