UMIN ID: UMIN000000953
Registered date:01/04/2008
Phase II study of pre-emptive therapy against CMV-associated disesase by valganciclovir after allogeneic hematopoietic stem cell transplantation
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Patients with CMV reactivation after allogeneic hematopoietic stem cell transplantation |
| Date of first enrollment | 2007/06/01 |
| Target sample size | 10 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | valganciclovir |
Outcome(s)
| Primary Outcome | Efficacy of valganciclovir against CMV reactivation |
|---|---|
| Secondary Outcome | Safety of valganciclovir after allogeneic HSCT Incidence of CMV-associated disease |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Negative CMV-Ab of both donor and recipient cord blood transplantion T-cell depleted or CD34-positive cell selected transplantion Gut GVHD (>=stage 2) HLA more than 2 locus disparity |
Related Information
| Primary Sponsor | Dept of 1st Intern Med, Kyushu Univ Hospital |
|---|---|
| Secondary Sponsor | Hamanomachi Hospital, Fukuoka, Japan |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Katsuto Takenaka |
| Address | 3-1-1 Maidashi Higashi-ku, Fukuoka 812-8592, Japan Japan |
| Telephone | 092-642-5230 |
| takenaka@intmed1.med.kyushu-u.ac.jp | |
| Affiliation | Kyushu University Hospital Dept of 1st Intern Med |
| scientific contact | |
| Name | Koji Nagafuji |
| Address | 3-1-1 Maidashi Higashi-ku, Fukuoka 812-8592, Japan Japan |
| Telephone | 092-642-5230 |
| Affiliation | Kyushu University Hospital Dept of 1st Intern Med |