Condition or disease | Intervention/treatment | Phase |
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Cytomegalovirus Infection | Drug: Letermovir Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 216 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3 Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Letermovir (LET) Prophylaxis When Extended From 100 Days to 200 Days Post-transplant in Cytomegalovirus (CMV) Seropositive Recipients (R+) of an Allogenic Hematopoietic Stem Cell Transplant (HSCT) |
Actual Study Start Date : | June 21, 2019 |
Estimated Primary Completion Date : | January 8, 2022 |
Estimated Study Completion Date : | May 30, 2022 |
Arm | Intervention/treatment |
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Experimental: Letermovir
Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.
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Drug: Letermovir
LET tablet or intravenous infusion at a total daily dose of 240 mg (when given with cyclosporin A) or 480 mg (when given alone).
Other Name: PREVYMIS™, MK-8228
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Placebo Comparator: Placebo
Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
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Drug: Placebo
Placebo was administered as tablets matched to LET or as inactive (saline) intravenous infusion.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Toll Free Number | 1-888-577-8839 | Trialsites@merck.com |
Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
Tracking Information | |||||||
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First Submitted Date ICMJE | April 26, 2019 | ||||||
First Posted Date ICMJE | April 29, 2019 | ||||||
Last Update Posted Date | April 23, 2021 | ||||||
Actual Study Start Date ICMJE | June 21, 2019 | ||||||
Estimated Primary Completion Date | January 8, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Percentage of participants with clinically-significant CMV infection from Week 14 (~100 days) post-transplant through Week 28 (~200 days) post-transplant [ Time Frame: From Week 14 (~100 day post-transplant) to Week 28 (up to ~200 days post-transplant) ] The percentage of participants with clinically-significant CMV infection from Week 14 to Week 28 will be determined in each arm.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040) | ||||||
Official Title ICMJE | A Phase 3 Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Letermovir (LET) Prophylaxis When Extended From 100 Days to 200 Days Post-transplant in Cytomegalovirus (CMV) Seropositive Recipients (R+) of an Allogenic Hematopoietic Stem Cell Transplant (HSCT) | ||||||
Brief Summary | The purpose of this study is to evaluate the safety and efficacy of letermovir (LET) versus placebo when extended from 100 days to 200 days post-transplant in cytomegalovirus (CMV) seropositive participants who received an allogenic hematopoietic stem cell transplant (HSCT). It is hypothesized that LET is superior to placebo in the prevention of clinically-significant CMV infection when LET prophylaxis is extended from 100 to 200 days. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Cytomegalovirus Infection | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
216 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | May 30, 2022 | ||||||
Estimated Primary Completion Date | January 8, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France, Germany, Italy, Japan, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03930615 | ||||||
Other Study ID Numbers ICMJE | 8228-040 2018-001038-17 ( EudraCT Number ) MK-8228-040 ( Other Identifier: Merck Sharp & Dohme Corp. ) 194797 ( Registry Identifier: JAPIC-CTI ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Merck Sharp & Dohme Corp. | ||||||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Merck Sharp & Dohme Corp. | ||||||
Verification Date | April 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |