Evidence map›Paper›PMID 25374055›Full record

Trial reportExpert review of hematology2014

Design of the INHIBIT trial: preventing inhibitors by avoiding 'danger', prolonging half-life and promoting tolerance.

Margaret V Ragni, Lynn M Malec

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Expert review of hematology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 16% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Emerging benefits of Fc fusion technology in the context of recombinant factor VIII replacement therapy.Haemophilia : the official journal of the World Federation of Hemophilia · 2020
    Review
  5. Article
  6. Review
  7. [Advances in Hemophilia A inhibitors].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2017
    Article
  8. Review
  9. Article
  10. 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

2 authors at 2 institutions in 1 country.

Margaret V RagniDepartment of Medicine, Division Hematology/Oncology, University of Pittsburgh, 3636 Boulevard of the Allies, Pittsburgh, 15213-4306, PA, USA.
Lynn M Malec
Children's Hospital of Pittsburgh · USUniversity of Pittsburgh · US

Funding

UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9M
University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
Feasibility of the Hemophilia INHIBIT TrialU34HL114674 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI RAGNI, MARGARET VICTORIA · 2012 to 2013
$715k
NCATS NIH HHS UL1 TR000005NCRR NIH HHS UL-1 RR024153NCRR NIH HHS UL1 RR024153NHLBI NIH HHS U34 HL114674PHS HHS U34 114674
6 · The paper itself

Abstract

Inhibitor formation is among the most serious complications of hemophilia treatment. With the US FDA licensure of the novel long-lasting recombinant factor VIII (FVIII) Fc fusion protein, Eloctate, which prolongs FVIII half-life, we propose an innovative approach to prevent inhibitor formation. In this paper, we describe a multicenter, Phase II, single-arm, 48-week trial, the INHIBIT trial, to determine if Eloctate, begun before a bleed and continued as once weekly prophylaxis, will reduce inhibitor formation in children with hemophilia A. We hypothesize that avoiding 'danger,' that is, immune activation by a bleed at first factor exposure and prolonging FVIII half-life will prevent inhibitors and promote FVIII-specific T-cell tolerance. If successful, this approach will suggest a new paradigm in clinical practice.

Indexed as

ChildChild, PreschoolFactor VIIIHalf-LifeHemophilia AHumansImmune ToleranceImmunity, CellularImmunoglobulin Fc FragmentsRecombinant Fusion ProteinsT-LymphocytesFactor VIIIfactor VIII-Fc fusion proteinImmunoglobulin Fc FragmentsRecombinant Fusion Proteinscoagulation factor VIIIhemophilia Ainhibitor formationlong-lasting factor VIIItoleranceTregs

Identifiers

PMID25374055
PMCPMC4356531
OpenAlexW2099128040

What OpenQuestion holds

Textmetadata
LicenceTDM
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.