A study to evaluate efficacy and safety of Valganciclovir in patients with cytomegalovirus disease.

JRCT ID: jRCT2051190075

Registered date:15/11/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Symptomatic congenital cytomegalovirus infection
• Date of first enrollment: 03/02/2020
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Valganciclovir 16 mg/kg is to be continuously administered twice daily for 6 months

Outcome(s)

• Primary Outcome: Change in whole blood viral load between baseline and 6 months

Secondary Outcome

(Significant secondary endpoint)
- Change in ABR (both best and total ear hearing assesments) between baseline and 6 months

(Other seconrady endpoints)
(1) Whole blood viral load at each time point
(2) Change in plasma viral load between baseline and 6 months
(3) Change in viral load of urine at each time point
(4) Improvement of thrombocytopenia, liver failure and retinitis between baseline and 6 months
(5) Growth indicators such as height, weight, head circumference, ability to role over and hold up one's head at each time point

Key inclusion & exclusion criteria

• Age minimum: >= 3weeks old
• Age maximum: <= 2month old
• Gender: Both

Include criteria

(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)

Exclude criteria

(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.

Related Information

• Primary Sponsor: Nozu Kandai