Evidence map›Paper›PMID 31814328›Full record

Trial reportClinical pharmacology in drug development2020

Pharmacokinetic Analysis of Weekly Versus Biweekly IgPro20 Dosing in Patients With Primary Immunodeficiency.

Mikhail A Rojavin, Hugo Chapdelaine, Michael A Tortorici, Michaela Praus, Gautam Baheti, Ying Zhang, Jutta Hofmann, Roxane Labrosse, Renée Dicaire, Elie Haddad

Open access · hybridAbstract readClinical Trial, Phase IVComparative Study
In one paragraph

Trial report in Clinical pharmacology in drug development, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 43% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. 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

10 authors at 6 institutions in 4 countries.

Mikhail A RojavinCSL Behring LLC, King of Prussia, Pennsylvania, USA.
Hugo ChapdelaineDepartment of Medicine, Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal, Quebec, Canada.
Michael A TortoriciCSL Behring LLC, King of Prussia, Pennsylvania, USA.
Michaela PrausCSL Behring GmbH, Marburg, Germany.
Gautam BahetiCSL Behring LLC, King of Prussia, Pennsylvania, USA.
Ying ZhangCSL Behring LLC, King of Prussia, Pennsylvania, USA.
Jutta HofmannCSL Behring AG, Bern, Switzerland.
Roxane LabrosseCHU Sainte-Justine, University of Montreal, Montreal, Quebec, Canada.
Renée DicaireCHU Sainte-Justine, University of Montreal, Montreal, Quebec, Canada.
Elie HaddadCHU Sainte-Justine, University of Montreal, Montreal, Quebec, Canada.
CSL (United States) · USCentre Hospitalier Universitaire Sainte-Justine · CABehringwerke (Germany) · DECSL (Switzerland) · CHMontreal Clinical Research Institute · CAUniversité de Montréal · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Flexible dosing of IgPro20 (Hizentra®, CSL Behring, King of Prussia, Pennsylvania) maintains normal serum immunoglobulin G (IgG) levels in patients with primary immunodeficiencies (PID). Until now, clinical trials testing the pharmacokinetic (PK) characteristics of serum IgG of weekly and biweekly subcutaneous IgG therapy were not published. This is the first study assessing PK characteristics following weekly and biweekly IgPro20 in patients with PID. The PK study was conducted in 2 parts: weekly dosing (12 weeks) and biweekly dosing (up to 12 months). Serum IgG concentration-time data were analyzed using noncompartmental methods to generate PK parameters. Fifteen patients provided PK samples for both dosing regimens. For weekly and biweekly regimens, mean doses per infusion were 109 and 213 mg/kg, respectively, and median t

Indexed as

AdolescentAdultAgedArea Under CurveDrug Administration ScheduleFemaleHumansImmunoglobulin GInjections, SubcutaneousMaleMiddle AgedPrimary Immunodeficiency DiseasesProspective StudiesYoung AdultHizentraImmunoglobulin GIgPro20pharmacokineticprimary immunodeficiency

Identifiers

PMID31814328
PMCPMC7586812
OpenAlexW2992701293

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.