Evidence map›Paper›PMID 31493216›Full record

Trial reportClinical drug investigation2019

Randomized Comparison Study of Novel Recombinant Human Antithrombin Gamma and Plasma-Derived Antithrombin in Healthy Volunteers.

Hidetoshi Furuie, Hironori Kanda

Open access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical drug investigation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 20% 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

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Article
  3. Antithrombin and Its Role in Host Defense and Inflammation.International journal of molecular sciences · 2021
    Review
  4. Comparison of Protective Effects of Recombinant Antithrombin Gamma and Plasma-Derived Antithrombin on Sepsis-Induced Disseminated Intravascular Coagulation and Multiple Organ Failure.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Observational
  5. A Suggested Link Between Antithrombin Dose and Rate of Recovery from Disseminated Intravascular Coagulation in Patients with Severe Organ Failure.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Article
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

2 authors at 1 institution in 1 country.

Hidetoshi FuruieOsaka Pharmacology Clinical Research Hospital, 4-1-29 Miyahara, Yodogawa-ku, Osaka, 532-0003, Japan. hidetoshi.furuie@heishinkai.com.
Hironori KandaKyowa Kirin Co, Ltd, Otemachi Financial City Grand Cube, 1-9-2 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan.
Kyowa Kirin (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThis paper describes two studies, which aimed to compare the safety and plasma antithrombin activity of recombinant human antithrombin gamma (rhAT-gamma) with plasma-derived antithrombin (pAT) 60 IU/kg, and to establish bioequivalence by adjusting the rhAT-gamma dose to that at which plasma antithrombin activity equaled that for pAT 60 IU/kg, based on results of the first study.

methodsHealthy adult men aged 20-45 years received once-daily doses of rhAT-gamma or pAT intravenously for 3 days (first study: 60 IU/kg of each; second study: 72 IU/kg of rhAT-gamma and 60 IU/kg of pAT). Maximum plasma antithrombin activity after three doses (C

resultsIn the first study, we compared AUCs to 121 h (when the lower limit of quantification was first observed). Mean C

conclusionsAs 90% confidence intervals for C

Indexed as

AdultAntithrombinsArea Under CurveHealthy VolunteersHumansMaleMiddle AgedRecombinant ProteinsTherapeutic EquivalencyYoung AdultAntithrombinsRecombinant Proteins

Identifiers

PMID31493216
PMCPMC6842348
OpenAlexW2971998904

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.