Trials Sponsors Conditions Drugs Pricing

Conditions

Churg-Strauss Syndrome Eosinophilic Esophagitis Eosinophilic Gastroenteritis Hypereosinophilic Syndromes

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)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Children's Hospital Medical Center, Cincinnati
Otherlead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

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 Diseases

Study Officials

Marc E. Rothenberg, MD
Children's Hospital Medical Center, Cincinnati
PRINCIPAL INVESTIGATOR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
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 2001

Actual (reported)

Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Anti-IL5 (Mepolizumab)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Anti-IL5 (Mepolizumab)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations