MK-8228 vs. Placebo in Prevention of CMV infection in HSCT Recipients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 570

Inclusion Criteria

1. be = 18 years of age on the day of signing informed consent.
2. have documented seropositivity for CMV (recipient CMV IgG seropositivity [R+]) within 1 year before HSCT.
3. be receiving a first allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant).
4. have undetectable CMV DNA (as confirmed by the central laboratory) from a plasma sample collected within 5 days prior to randomization.
5. be within 28 days post-HSCT at the time of randomization.
6. be highly unlikely to become pregnant or to impregnate a partner

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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 270

Exclusion Criteria

1. received a previous allogeneic HSCT
2. has a history of CMV end-organ disease within 6 months prior to randomization.
3. has evidence of CMV viremia from a central or local laboratory at any time prior to randomization.
4. received within 7 days prior to screening or plans to receive during the study any of the following: ganciclovir; valganciclovir; foscarnet; acyclovir (at doses > 3200 mg PO per day or > 25 mg/kg IV per day); valacyclovir (at doses > 3000 mg PO per day); famciclovir (at doses > 1500 mg PO per day)
5. received within 30 days prior to screening or plans to receive during the study any of the following: cidofovir; CMV hyper-immune globulin; Any investigational CMV antiviral agent/biologic therapy
6. has severe hepatic insufficiency within 5 days prior to randomization.
7. has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 x the upper limit of normal (ULN) or serum total bilirubin > 2.5 x ULN within 5 days prior to randomization.
8. has end-stage renal impairment with a creatinine clearance less than 10 mL/min, as calculated by the Cockcroft-Gault equation using serum creatinine within 5 days prior to randomization.
9. has an uncontrolled infection on the day of randomization.
10. requires mechanical ventilation or is hemodynamically unstable at the time of
randomization.
11. has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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