Conditions: HCMV
Keywords: Safety, efficacy, pharmacokinetics, CSJ148, HCMV, HCMV viral load, immunogenicity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 86
Healthy volunteers: no

Brief summary:
This study is designed to test if CSJ148 can prevent HCMV replication after stem cell transplantation.

Detailed description:
This study is randomized, double-blinded, and placebo-controlled. 80 Patients will be enrolled and randomized to CSJ148 and placebo in a ratio of 3:1. Patients undergoing stem cell transplantation will be enrolled into the study. The study will consist of a screening period, a baseline visit, approximately 3-month treatment exposure period, an end-of-therapy visit, a follow-up period, and a study completion evaluation approximately 3.5 months after the last dose of study drug is administered.

Arms:
arm 1: Cohort 1: CSJ148 IV q 4weeks arm 2: Cohort 2: CSJ148 IV q 4weeks arm 3: Cohort 2: Placebo IV q 4weeks

Interventions: intervention 1: CSJ148 intervention 2: Placebo
Intervention descriptions: intervention 1: CSJ148 IV q 4weeks intervention 2: Placebo IV q 4weeks

Protocol document: