Evidence map›Paper›PMID 21833452›Full record

Trial reportThrombosis and haemostasis2011

Phase II prospective open-label trial of recombinant interleukin-11 in women with mild von Willebrand disease and refractory menorrhagia.

Margaret V Ragni, Rachel C Jankowitz, Kristen Jaworski, Elizabeth P Merricks, Mark T Kloos, Timothy C Nichols

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Thrombosis and haemostasis, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00524342 (Phase II Clinical Efficacy Trial of Recombinant Interleukin-11), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 21% 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.

NCT00524342 phase2completednot on this map

Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Women With Type 1 Von Willebrand Disease and Refractory Menorrhagia

TypeinterventionalSponsorMargaret RagniRan2008 to 2010Enrolled7ConditionsVon Willebrand DiseaseArmsOprelvekin, Interleukin 11, IL-11
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Von Willebrand factor for menorrhagia: a survey and literature review.Haemophilia : the official journal of the World Federation of Hemophilia · 2016
    Review
  12. Lessons Learned from Animal Models of Inherited Bleeding Disorders.Hematology education. European Hematology Association. Congress. Education Program · 2014
    Article
  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

6 authors at 1 institution in 1 country.

Margaret V RagniDivision Hematology/Oncology, Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. ragni@dom.pitt.edu
Rachel C Jankowitz
Kristen Jaworski
Elizabeth P Merricks
Mark T Kloos
Timothy C Nichols
University of Pittsburgh Medical Center · 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
Maintenance of Models of Human Hemophilia and VWDR24HL063098 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI NICHOLS, TIMOTHY CHARLES · 1999 to 2019
$15.1M
Prevention of the Complications of Bleeding Disorders Through HTCSU01DD000193 · DD · UNIVERSITY OF PENNSYLVANIA · PI BUTLER, REGINA · 2006 to 2010
$4.1M
NCBDD CDC HHS U01 DD000193NCBDD CDC HHS U10DD000193NCRR NIH HHS UL-1 RR024153NCRR NIH HHS UL1 RR024153NHLBI NIH HHS R24 HL063098PHS HHS 1-H-30-MC-00038-01
6 · The paper itself

Abstract

Lack of effective treatment for menorrhagia is the greatest unmet healthcare need in women with von Willebrand disease (VWD). We conducted a single-centre phase II clinical trial to determine efficacy and safety of recombinant IL-11 (rhIL-11, Neumega®) given subcutaneously for up to seven days during six consecutive menstrual cycles each in seven women with mild VWD and menorrhagia refractory to haemostatic or hormonal agents. rhIL-11 reduced menstrual bleeding severity as measured by pictorial blood assessment chart (PBAC) ≥ 50% (to <100) in 71% of subjects, cycle severity ≥ 50% in 71%, and bleeding duration ≥ 2 days in 85%, all p ≤ 0.01. After rhIL-11, plasma VWF:RCo increased 1.1-fold, but did not correlate with PBAC, r=0.116, bleeding duration, r=0.318, or cycle severity, r=-0.295, or hsCRP, r=-0.003, all p>0.05. Platelet VWF mRNA expression by quantitative PCR increased mean four-fold (1.0-13.5). rhIL-11 was well tolerated with grade 1 or less fluid retention, flushing, conjunctival erythema, and local bruising. In summary, rhIL-11 reduces menorrhagia safely and warrants further study.

Indexed as

ImmunotherapyAdolescentAdultBlood PlateletsDisease ProgressionDrug ResistanceErythemaFemaleHumansInjections, SubcutaneousInterleukin-11MenorrhagiaMiddle AgedProspective StudiesRecombinant Proteinsvon Willebrand DiseasesInterleukin-11Recombinant Proteinsvon Willebrand Factor

Identifiers

PMID21833452
PMCPMC3947632
OpenAlexW2165167860

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.