Evidence map›Paper›PMID 28675594›Full record

Trial reportClinical and translational science2017

Intravenous Hydroxypropyl β-Cyclodextrin Formulation of Letermovir: A Phase I, Randomized, Single-Ascending, and Multiple-Dose Trial.

K Erb-Zohar, D Kropeit, J Scheuenpflug, H-P Stobernack, Egj Hulskotte, A van Schanke, H Zimmermann, H Rübsamen-Schaeff

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 31 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. Observational
  7. Article
  8. Antiviral Drugs Against Herpesviruses.Advances in experimental medicine and biology · 2021
    Article
  9. Review
  10. Review
  11. Moving Past Ganciclovir and Foscarnet: Advances in CMV Therapy.Current hematologic malignancy reports · 2020
    Review
  12. Review
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 3 countries.

K Erb-Zoharclinphase, Hanau, Germany.
D KropeitAiCuris Anti-infective Cures GmbH, Wuppertal, Germany.
J ScheuenpflugMerck Biopharma, Darmstadt, Germany.
H-P StobernackAiCuris Anti-infective Cures GmbH, Wuppertal, Germany.
Egj HulskotteMerck Sharp & Dohme, The Netherlands.
A van SchankeQuantitative Solutions BV, Oss, The Netherlands.
H ZimmermannAiCuris Anti-infective Cures GmbH, Wuppertal, Germany.
H Rübsamen-SchaeffAiCuris Anti-infective Cures GmbH, Wuppertal, Germany.
AiCuris (Germany) · DEKlinikum Hanau · DEMerck (Germany) · DEMSD (Netherlands) · NLQuantitative BioSciences · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Letermovir is a novel antiviral in clinical development for prophylaxis against human cytomegalovirus in immunocompromised transplant recipients. This two-part, single-center, randomized, double-blind, placebo-controlled trial evaluated the safety and pharmacokinetics of a hydroxypropyl β-cyclodextrin (HPβCD)-based intravenous formulation of letermovir in healthy women. Subjects received single, escalating doses (120, 240, 480, 720, and 960 mg; 6 letermovir, 2 placebo per cohort) or multiple, once-daily doses (240 mg; 8 letermovir, 4 placebo) of HPβCD-formulated letermovir and the associated pharmacokinetic profiles and adverse events were investigated. Single-dose and multiple-dose regimens were generally well tolerated. Single-dose escalation resulted in a slightly more-than-dose-proportional increase in the area under the letermovir plasma concentration-time curve (AUC), whereas increase in the maximal observed letermovir plasma concentration (C

Indexed as

2-Hydroxypropyl-beta-cyclodextrinAcetatesAdministration, IntravenousAdultArea Under CurveDemographyDose-Response Relationship, DrugFemaleHumansMiddle AgedQuinazolinesTime FactorsVisual Analog ScaleYoung Adult2-Hydroxypropyl-beta-cyclodextrinAcetatesletermovirQuinazolines

Identifiers

PMID28675594
PMCPMC6402190
OpenAlexW2731929506

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.