Evidence map›Paper›PMID 27279130›Full record

Trial reportJournal of clinical immunology2016

Flebogamma(®) 5 % DIF Intravenous Immunoglobulin for Replacement Therapy in Children with Primary Immunodeficiency Diseases.

Mark Ballow, Paul J Pinciaro, Timothy Craig, Gary Kleiner, James Moy, Hans D Ochs, John Sleasman, William Smits

Abstract readClinical Trial, Phase IVMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of clinical immunology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 37% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Observational
  5. Article
  6. Article
  7. Observational
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 7 institutions in 1 country.

Mark BallowThe Children's Hospital of Buffalo, Buffalo, NY, USA. markbal.aird@gmail.com.
Paul J PinciaroGrifols Biologicals Inc., Los Angeles, CA, USA.
Timothy CraigPenn State University Hershey Medical Center, Hershey, PA, USA.
Gary KleinerJeffrey Modell Diagnostic Center for Primary Immunodeficiencies, University of Miami, Miami, FL, USA.
James MoyAllergy and Immunology, Rush University Medical Center, Chicago, IL, USA.
Hans D OchsSeattle Children's Research Institute and University of Washington, Seattle, WA, USA.
John SleasmanDivision of Allergy and Immunology, Department of Pediatrics, University of South Florida, 601 4th Street South, Saint Petersburg, FL, 3370, USA.
William SmitsThe Allergy and Asthma Center, Fort Wayne, IN, USA.
Grifols (United States) · USPenn State Milton S. Hershey Medical Center · USRush University Medical Center · USUniversity of Miami · USUniversity of South Florida St. Petersburg · USUniversity of Washington · USWomen & Children's Hospital of Buffalo · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe previous studies with Flebogamma(®) 5 % DIF intravenous immunoglobulin (IVIG) contained insufficient numbers of pediatric subjects to fully warrant a pediatric indication by the FDA. The objective of this study was to evaluate the efficacy, safety, and pharmacokinetics of Flebogamma® 5 % DIF for replacement therapy in children (age 2-16) with primary immunodeficiency diseases (PIDD).

methodsIVIG was administered at eight clinical sites to 24 subjects with well-defined PIDD at a dose of 300-800 mg/kg every 21-28 days for 12 months. The pharmacokinetics endpoint in this study was the dose-adjusted increment of the serum IgG trough levels.

resultsThe calculated serious bacterial infection rate was 0.05/subject/year. The incidence of adverse events considered potentially related to IVIG during or within 72 h after completing an infusion was within the FDA guidance threshold of <40 % at each time point. Dose-adjusted incremental IgG levels remained approximately equal to or slightly greater than pre-study IgG levels (between 800 and 1000 mg/dL throughout) when the subjects were treated with IVIG therapy other than Flebogamma(®) DIF 5 % indicating no evidence of a different pharmacokinetic profile in this pediatric population if compared to those profiles in previous Flebogamma studies in predominately adult populations.

conclusionsFlebogamma(®) 5 % DIF is efficacious and safe, has adequate pharmacokinetic properties, is well-tolerated, and maintains the profile of Flebogamma(®) 5 % for the treatment of children with primary humoral immunodeficiency diseases.

Indexed as

AdolescentBacterial InfectionsChildChild, PreschoolFemaleHumansImmunoglobulins, IntravenousImmunologic Deficiency SyndromesMaleTime FactorsTreatment OutcomeImmunoglobulins, Intravenousclinical trialFlebogamma® 5 % DIFimmunologic deficiency syndromesIntravenous immune globulinIVIG

Identifiers

PMID27279130
OpenAlexW2415340552

What OpenQuestion holds

Textmetadata
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.