A study to evaluate efficacy and safety of Valganciclovir in patients with cytomegalovirus disease.
- Conditions
- Symptomatic congenital cytomegalovirus infection
- Registration Number
- JPRN-jRCT2051190075
- Lead Sponsor
- ozu Kandai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
(1)Confirmation of CMV nucleic acid from urine by PCR tests within 21days of age
(2)Symptomatic congenital CMV disease, as central nervous system by one or more of the following
1)Microcephaly
2)Hydrocephalus / Ventricular enlargement
3)Periventricular calcification
4)Cortical hypoplasia / white matter disorder.
5)Retinal choroiditis
6)Abnormal ABR
(3)<60 days of age at informed consent
(4)Gestational age > 32 weeks at birth
(5)Weight at study enrolment > 1,800 grams
(6)Signed informed consent from parent(s) or legal guardian(s)
(1)Patients with bacterial infection requiring antibiotics
(2) Documented renal insufficiency, as noted by a creatinine clearance > 1.5 mg/dl at time of study enrollment
(3)Anencephalopathy and hydrocephalus by other causes
(4)Neutrophil count < 500/mm3 or the Platelet count < 25,000/mm3
(5)Infants known to be born to women who are HIV positive and HIV positive infants
(6)Patients who are judged as inappropriate by a study investigator or sub-investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in whole blood viral load between baseline and 6 months
- Secondary Outcome Measures
Name Time Method (Significant secondary endpoint)<br>- Change in ABR (both best and total ear hearing assesments) between baseline and 6 months<br><br>(Other seconrady endpoints)<br>(1) Whole blood viral load at each time point<br>(2) Change in plasma viral load between baseline and 6 months<br>(3) Change in viral load of urine at each time point<br>(4) Improvement of thrombocytopenia, liver failure and retinitis between baseline and 6 months <br>(5) Growth indicators such as height, weight, head circumference, ability to role over and hold up one's head at each time point