Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections

• Register: ClinicalTrials.gov
• Last refreshed on: 28 January 2013
• Main ID: NCT00466817
• Date of registration: 26/04/2007
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections
• Scientific title: A Phase III, Randomized, Placebo-Controlled Blinded Investigation of Six Weeks vs. Six Months of Oral Valganciclovir Therapy in Infants With Symptomatic Congenital Cytomegalovirus Infection (CASG 112)
• Date of first enrolment: June 2008
• Target sample size: 109
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00466817
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

United Kingdom, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent from parent(s) or legal guardian(s)

- Confirmation of cytomegalovirus (CMV) from urine or throat swab specimens by culture,
shell vial, or polymerase chain reaction (PCR) tests

- Symptomatic congenital CMV disease, as manifest by one or more of the following:

1. Thrombocytopenia

2. Petechiae

3. Hepatomegaly

4. Splenomegaly

5. Intrauterine growth restriction

6. Hepatitis (elevated transaminases and/or bilirubin)

7. Central nervous system (CNS) involvement of the CMV disease [such as
microcephaly, radiographic abnormalities indicative of CMV CNS disease, abnormal
cerebrospinal fluid (CSF) indices for age, chorioretinitis, hearing deficits as
detected by formal brainstem evoked response (not a screening auditory brainstem
response {ABR}), and/or positive CMV PCR from CSF]

- Less than or equal to 30 days of age at study enrollment

- Weight at study enrollment greater than or equal to 1800 grams

- Gestational age greater than or equal to 32 weeks at birth

Exclusion Criteria:

- 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)

- Documented renal insufficiency, as noted by a creatinine clearance less than 10
mL/min/1.73m^2 at time of study enrollment

- Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet,
cidofovir, or maribivir

- Infants known to be born to women who are human immunodeficiency virus (HIV) positive
(but HIV testing is not required for study entry)

- Current receipt of other investigational drugs



Age minimum: N/A
Age maximum: 30 Days
Gender: Both

Health Condition(s) or Problem(s) studied

Cytomegalovirus Infections

Intervention(s)

Drug: Placebo

Drug: Valganciclovir

Primary Outcome(s)

Change in best ear hearing assessments. [Time Frame: Between baseline and 6 months.]

Secondary Outcome(s)

Adverse events which lead to permanent discontinuation of valganciclovir therapy or to irreversible outcome of the adverse event. [Time Frame: Through study month 7.]

Change in best ear hearing assessments. [Time Frame: Between baseline and 12 months and baseline and 24 months.]

Hearing deterioration over left and right ears. [Time Frame: Between baseline and 6, 12, or 24 months.]

Maximum change in hearing assessments over left and right ears. [Time Frame: Between baseline and 6, 12, and 24 months.]

Neurological impairment utilizing the Bayley Scales of Infant and Toddler Development. [Time Frame: 12 and 24 months of life.]

Secondary ID(s)

06-0046

CASG 112

N01AI30025C

Source(s) of Monetary Support

Please refer to primary and secondary sponsors