NCT00266565

Brief Summary

Toxicity of anti-IL-5

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2001

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2005

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

3.3 years

First QC Date

December 15, 2005

Last Update Submit

July 27, 2020

Conditions

Hypereosinophilic SyndromesEosinophilic GastroenteritisChurg-Strauss SyndromeEosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

  • To assess the toxicity of anti-IL-5 in patients with hypereosinophilia

    28 weeks

Secondary Outcomes (2)

  • To assess whether anti-IL-5 lowers peripheral blood eosinophils and/or tissue in patients with hypereosinophilia

    28 weeks

  • To assess whether anti-IL-5 has a steroid and/or interferon sparing effect

    28 weeks

Study Arms (1)

Anti-IL5 (Mepolizumab)

EXPERIMENTAL

The purpose of the study is to assess the toxicity of anti-IL-5 (Mepolizumab), and to see whether it lowers eosinophils in peripheral blood and/or tissue and whether it has a steroid and/or interferon sparing effect.

Drug: Mepolizumab

Interventions

MepolizumabDRUG

10mg/kg (max 750 ml) once a month for 3 months

Also known as: Anti-IL5
Anti-IL5 (Mepolizumab)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adequate renal, cardiac, and hepatic function
  • Not pregnant or breastfeeding
  • A diagnosis of hypereosinophilic syndrome such as:
  • Idiopathic hypereosinophilic syndrome;
  • Eosinophilia myalgia syndrome;
  • Eosinophilic gastroenteritis;
  • Churg-Strauss syndrome;
  • Eosinophilic cellulitis;
  • Benign hypereosinophilia; or
  • Eosinophilic esophagitis.
  • Maintained on, or in need of, the following: glucocorticoids, interferon, methotrexate, hydroxyurea, cytoxan, 6-mercaptopurine, or vincristine
  • Blood eosinophil counts greater than 750 cells/mcl

You may not qualify if:

  • Creatinine \> 3 X upper limit for age
  • AST \> 5 X upper limit for age
  • Platelet count \< 50,000/mm3
  • Cardiac function:
  • NYHA class IIIb or IV (patients with shortness of breath or fatigue with mild exertion or at rest);
  • Patients with symptomatic supraventricular or ventricular arrythmias requiring treatment;
  • Patients requiring IV heart failure medications;
  • Angina or acute myocardial infarction
  • History of renal, hepatic, endocrine, oncologic, cardiovascular disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the patient or impact on the validity of the study results
  • History of allergic or adverse response to previous antibody type therapy
  • History of allergic or adverse response to anti-IL-5 therapy
  • Evidence of, or history of, a parasitic infection (within past 1 year)
  • Participation in a previous clinical trial involving an investigational agent within 30 days prior to study initiation
  • Receipt of anti-IL-5 therapy in the past
  • Blood donation of 450 ml (1 pint) or more within 30 days prior to study initiation
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

MeSH Terms

Conditions

Hypereosinophilic SyndromeEosinophilic enteropathyChurg-Strauss SyndromeEosinophilic Esophagitis

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

EosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisSystemic VasculitisVasculitisVascular DiseasesCardiovascular DiseasesGranulomaLymphoproliferative DisordersLymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesEsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisHypersensitivity, ImmediateHypersensitivity

Study Officials

  • Marc E. Rothenberg, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2005

First Posted

December 19, 2005

Study Start

December 1, 2001

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

US(1)