A Study of Letermovir (MK-8228) to Evaluate Efficacy and Safety for Prevention of Cytomegalovirus Infection in Chinese Hematopoietic Stem Cell Transplant Recipients (MK-8228-045)

NCT05763823 on ClinicalTrials.gov Phase 3 Merck Sharp & Dohme LLC (industry) Started 2023-03-24 Completed

Riskier than 52% of active trials

Model scores of the 29,894 trials active now.

Model score 17% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (876 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2024-04-18, after 2023-03-24 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-04-18. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: randomizationprior todaystime ofantibody
Phrases that lowered it: participantcellefficacy andmkevaluate the
Sponsor's past termination rate: 16.5% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Sponsor's past trials: 1414 (raises risk) · Sponsor's track record
Primary purpose: prevention (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 117 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Design: single group (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 19.5% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports marked serious: 81.6% (lowers risk) · Drug's FDA history

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 3 (typical: 2)
Number of arms: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: prevention (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 1414 (typical: 32)
Sponsor's past termination rate: 16.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 117 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 1475 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 410 (typical: 412.5)
Drug's FAERS reports marked serious: 81.6% (typical: 85.6%)
Drug's FAERS reports with a death: 19.5% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease
Drugs matched to FDA substances: letermovir

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001) NCT02137772 · started 2014 · scored riskier than 53% of active trials completed
MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042) NCT04129398 · started 2019 · scored riskier than 42% of active trials completed
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) NCT03930615 · started 2019 · scored riskier than 62% of active trials completed
Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002) NCT03443869 · started 2018 · scored riskier than 34% of active trials completed
A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection NCT04017962 · started 2019 · scored riskier than 96% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.