Effectiveness of Ganciclovir / Valganciclovir Dose Optimization by NUDT 15 R139C mutation on Reducing Ganciclovir/Valganciclovir-induced Leucopenia in Congenital Cytomegalovirus Infection

Open Label Single-arm, Multicenter Trial for Reducing Ganciclovir / Valganciclovir in Congenital Cytomegalovirus Infection with NUDT 15 R139C mutation - OPTIGAN trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000052037

Enrollment

Registered

2023-11-01

Start date

2023-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Congenital Cytomegalovirus Infection or Acquired cytomegalovirus infection in Preterm Birth Infants

Interventions

Patients with NUDT15 R139C heterozygous mutation are administered with 50% dose of ganciclovir/valganciclovir. Patients with NUDT15 R139C homozygous mutation are administered with 10% dose of gancicl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with NUDT15 R139C hetero/homozygous mutation. 2. Patients who met the drug withdrawal criteria after normal doses of ganciclovir/valganciclovir. (Any of the following drug withdrawal criteria: Neutrophil < 500/mm3, Platelet < 50,000/mm3, Hemoglobin < 8g/dL, AST or ALT > 500 IU/mL or more than 10 times the base levels.)

Exclusion criteria

Exclusion criteria: 1. No improvement of symptoms at the time of drug withdrawal. 2. The Inhibitory effect of virus titer cannot be confirmed at the time of drug withdrawal.

Design outcomes

Primary

Measure	Time frame
Suppression of Cytomegalovirus titer in blood, Improvement of clinical symptoms, and Side effects are evaluated weekly during therapy.	—

Countries

Japan

Contacts

Public ContactYuka Torii

Nagoya University Hospital Division of Pediatrics

yucali@med.nagoya-u.ac.jp0527442294

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026