Trial · NCT03728426

Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection

NCT03728426, Phase 2, Completed, Amy C. Sherman, MD; results first posted 2023-03-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection. Trials, record NCT03728426. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03728426

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection
NCT number: NCT03728426
Status: Completed
Phases: Phase 2
Enrollment: 10 participants, actual
Lead sponsor: Amy C. Sherman, MD
Conditions: Cytomegalovirus Infections
Interventions: Letermovir
First posted: 2018-11-02
Last updated: 2023-03-08
Results first posted: 2023-03-08
Limitations and caveats: This study did not reach the target number of participants needed to achieve target power and statistically reliable results. The study was closed early due to difficulty in recruiting during the COVID-19 pandemic.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Virological Response on Treatment Week 6	6 weeks	The virologic response milestones are defined as: 1) Any decrease in CMV DNA from baseline (Week 0), measured on week 3 and 2) A ≥2 log decrease in CMV DNA from baseline, or an undetectable CMV DNA, measured on week 6. For patients with clinical CMV disease, the clinical response milestones are defined as: 1) Stabilization of clinical disease by week 3 (i.e. no worsening signs or symptoms compared to week 1) as assessed by the site investigator and 2) Improvement or resolution of clinical disease by week 6 (i.e., improvement in signs and symptoms of affected organs \[resolution of diarrhea, pneumonia, hepatitis, retinitis, etc.\]) 3) Patients with clinical CMV disease should also meet virological response milestones outlined above to support the continuation of letermovir therapy. Patients who enter the study based solely on documented CMV disease by histopathology in the absence of quantifiable CMV virus load should remain nonquantifiable (less than 137 IU/mL).
Secondary	Overall Survival	6 months	number of patients alive
Secondary	CMV Progression-free Survival	6 months	Time from study enrollment to CMV progression or death whichever occurs first
Secondary	Kinetics of Viral Clearance	6 months	time to undetectable plasma CMV DNA
Secondary	Percent of Patients With a Clinically Meaningful Treatment Response to Letermovir Treatment	6 Weeks	Virological response and a concomitant clinical response in patients with CMV disease by Week 6 of treatment. For patients with clinical CMV disease, the clinical response milestones are defined as: 1. Stabilization of clinical disease by week 3 (i.e. no worsening signs or symptoms compared to week 1) as assessed by the site investigator and 2. Improvement or resolution of clinical disease by week 6 (i.e., improvement in signs and symptoms of affected organs \[resolution of diarrhea, pneumonia, hepatitis, retinitis, etc.\]) 3. Patients with clinical CMV disease should also meet virological response milestones outlined above to support the continuation of letermovir therapy. Patients who enter the study based solely on documented CMV disease by histopathology in the absence of quantifiable CMV virus load should remain nonquantifiable (less than 137 IU/mL).
Secondary	Emergence of Letermovir-resistant CMV Virus in Patients Treated in This Setting	6 months	Number of participants with breakthrough letermovir-resistant CMV infection in patients receiving letermovir treatment who experienced an initial virological response.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Virological Response on Treatment Week 6	6 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival	6 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	CMV Progression-free Survival	6 months	5 participants had CMV progression or death	days	MEDIAN
SECONDARY	Kinetics of Viral Clearance	6 months	All participants	days	MEDIAN
SECONDARY	Percent of Patients With a Clinically Meaningful Treatment Response to Letermovir Treatment	6 Weeks	1 participant met the definition for CMV disease	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Emergence of Letermovir-resistant CMV Virus in Patients Treated in This Setting	6 months	All participants analyzed for letermovir breakthrough infections	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Virological Response on Treatment Week 6	Letermovir	5		Participants
Overall Survival	Letermovir	7		Participants
CMV Progression-free Survival	Letermovir	13	Inter-Quartile Range 13 to 19	days
Kinetics of Viral Clearance	Letermovir	166	Inter-Quartile Range 147 to 168	days
Percent of Patients With a Clinically Meaningful Treatment Response to Letermovir Treatment	Letermovir	0		Participants
Emergence of Letermovir-resistant CMV Virus in Patients Treated in This Setting	Letermovir	0		Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Letermovir	10
Overall Study	COMPLETED	Letermovir	7
Overall Study	NOT COMPLETED	Letermovir	3

Source ClinicalTrials.gov

Adverse events50

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Letermovir	4	10
other	Diarrhea	Gastrointestinal disorders	Letermovir	2	10
other	Lung infection	Respiratory, thoracic and mediastinal disorders	Letermovir	1	10
other	Alanine aminotransferase increased	Hepatobiliary disorders	Letermovir	2	10
other	Bacteremia	Infections and infestations	Letermovir	2	10
other	Epistaxis	Blood and lymphatic system disorders	Letermovir	2	10
other	Peripheral sensory neuropathy	Nervous system disorders	Letermovir	2	10
other	Pneumothorax	Respiratory, thoracic and mediastinal disorders	Letermovir	2	10
other	Rash maculo-papular	Skin and subcutaneous tissue disorders	Letermovir	2	10
other	Upper respiratory infection	Respiratory, thoracic and mediastinal disorders	Letermovir	2	10

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Letermovir	3	10
Total, other adverse events	Letermovir	10	10
Total, serious adverse events	Letermovir	6	10

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29211658	BACKGROUND	PubMed
33197929	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03728426

GET https://conductscience.org/api/trials/v1/NCT03728426/events?page=2

API reference For AI assistants