A PHASE III RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF MK-8228 (LETERMOVIR) FOR THE PREVENTION OF CLINICALLY SIGNIFICANT HUMANCYTOMEGALOVIRUS (CMV) INFECTION IN ADULT, CMV-SEROPOSITIVE ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT RECIPIENTS

Not Applicable

• Conditions: -B25 Cytomegaloviral disease; Cytomegaloviral disease; B25

• Registration Number: PER-014-14
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-08
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. be ≥ 18 years of age
2. positive serology for CMV
3. be receiving a first allogeneic HSCT
4. have undetectable CMV DNA within 5 days prior to randomization.
5. be within 28 days post-HSCT at the time of randomization.
6. Female subjects who have initiated menstruation must have negative pregnancy test prior to randomization. Females of reproductive potential must remain abstinent or use barrier methods at least 14 days prior, during and 90 days after last dose of study therapy. Females using hormonal contraceptives must use a barrier method as well. In countries where abstinence is not permitted, local approved contraceptive methods must be used.
A male subject who is of reproductive potential must use contraceptive barrier methods and ensure his partner uses contraceptive methods approved by protocol.
7. be able to read, understand, and complete questionnaires and diaries.
8. provide written informed consent

Exclusion Criteria

received allogeneic HSCT, CMV end-organ disease 6 months prior to rando, CMV viremia prior to rando, received within 30 days prior to screening/plans to receive during the study any prohibited medication per protocol, hypersensitivity to compounds of MK8228, severe hepatic insufficiency within 5 days prior to rando, serum AST or ALT > 5 x ULN or BILI > 2.5 x ULN within 5 days prior to rando, end-stage renal impairment 5 days prior to rando, has both moderate hepatic and/or renal insufficiency, infection on the day of rando, requires mechanical ventilation/is hemodynamically unstable at the time of rando, Positive for HIV, Hep C, Hep B 90 days prior to rando, active solid tumor malignancies, pregnant/expecting to conceive from the time of consent through 90 days after the last dose of MK8228, expecting to donate eggs or sperm starting from the time of consent through 90 days after the last dose of MK8228, participating/participated in a study with investigational compound/device within 28 days/5X half-life of the investigational compound, participated in a study involving MK-8228, participated/participating in any study involving anti CMV treatment, is or has an immediate family member who is investigational site or Sponsor staff directly involved with this trial, user of recreational/illicit drugs, history or current evidence of any condition as judged by the investigator is not in the best interest of the subject to participate in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified