Efficacy and Safety study of CSJ148 in stem cell transplant patients
- Conditions
- human cytomegalovirus (HCMV) in stem cell transplant patientsMedDRA version: 19.0Level: LLTClassification code 10009703Term: CMV infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-002150-39-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 86
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 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).
other protocol-defined inclusion criteria may apply”
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 76
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
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.
other protocol-defined exclusion criteria may apply”
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To assess the efficacy of CSJ148 on preventing active HCMV infection during the first 98 days after stem cell transplant.<br>2. To assess the safety and tolerability of CSJ148 when administered to stem cell transplant recipients.;Secondary Objective: 1. To assess if CSJ148 can increase the time to start preemptive therapy.<br>2. To assess if CSJ148 can reduce the number of times that preemptive therapy is required.<br>3. To assess if CSJ148 can reduce the proportion of patients developing HCMV disease.<br>4. To assess the PK of CSJ148 in stem cell transplant recipients.;Primary end point(s): 1. Number of participants who require preemptive HCMV therapy<br>2. Number of participants with adverse events as a measure of safety and tolerability;Timepoint(s) of evaluation of this end point: 99 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Time to initiation of preemptive HCMV therapy<br>2. Number of times that preemptive HCMV therapy is required<br>3. Number of participants developing HCMV disease<br>4. Area under the serum concentration-time curve during the dosing interval (AUCtau)<br>5. Maximum serum concentration during the dosing interval (Cmax)<br>6. Trough serum concentration (Ctrough) prior to the next dose administration;Timepoint(s) of evaluation of this end point: 99 days