Efficacy and Safety study of CSJ148 in stem cell transplant patients
- Conditions
- human cytomegalovirus (HCMV) in stem cell transplant patientsMedDRA version: 17.1Level: LLTClassification code 10009703Term: CMV infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-002150-39-BE
- 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 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).
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