Efficacy and Safety Study of CSJ148 in Stem Cell Transplant Patients
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/10/2017 |
Start Date: | June 2, 2015 |
End Date: | December 7, 2016 |
A Multi-center, Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of CSJ148 Compared to Placebo to Prevent Human Cytomegalovirus (HCMV) Replication in Stem Cell Transplant Patients
This study is designed to test if CSJ148 can prevent HCMV replication after stem cell
transplantation.
transplantation.
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.
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.
Inclusion Criteria:
- Male and female patients at least 18 years of age scheduled to undergo allogeneic bone
marrow, peripheral blood stem cell, or cord blood transplantation and begin
conditioning chemotherapy within 24-48 hours of planned dosing day.
- Subject seropositive for HCMV before transplantation; donor can be seropositive or
seronegative for HCMV (donor positive/recipient positive or donor negative/recipient
positive).
Exclusion Criteria:
- Have had HCMV-related organ disease within 6 months prior to enrollment.
- Detectable HCMV infection (positive pp65 antigenemia or plasma HCMV DNA polymerase
chain reaction (PCR) assays prior to enrollment
- Received any of the following within 30 days prior to enrollment: ganciclovir,
valganciclovir, foscarnet, cidofovir, acyclovir (>25 mg/kg/day IV), valacyclovir (>3
gm/day oral), famciclovir (>1500 mg/day oral), HCMV immune globulin, immune globulin
(>500 mg/kg), or any other medication with anti-HCMV activity.
- Require mechanical ventilation within 7 days prior to enrollment.
- Received any vasopressors or other agents for hemodynamic support within 7 days prior
to enrollment.
- Impaired renal function requiring dialysis.
We found this trial at
6
sites
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