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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00266565
Other study ID # 01-9-18
Secondary ID FD-R-002396
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date December 2001
Est. completion date April 2005

Study information

Verified date July 2020
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Toxicity of anti-IL-5


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date April 2005
Est. primary completion date April 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Creatinine > 3 X upper limit for age

- AST > 5 X upper limit for age

- Platelet count < 50,000/mm3

- Cardiac function:

1. NYHA class IIIb or IV (patients with shortness of breath or fatigue with mild exertion or at rest);

2. Patients with symptomatic supraventricular or ventricular arrythmias requiring treatment;

3. Patients requiring IV heart failure medications;

4. 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

- Abnormal or unusual diet or substantial changes in eating habits within 30 days prior to, or during, the study.

- Patients who do not have eosinophil levels > 750 cells/mcl after the run-in period. Patients who have only eosinophilic infiltration of tissue are eligible if they do not develop an eosinophil level > 750 cells/mcl, assuming that they meet all other eligibility requirements.

- Positive serum pregnancy test

- Breastfeeding

- Unable to use effective birth control methods for duration of study

- Unable or unwilling to give voluntary informed consent/assent

Study Design


Intervention

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

Locations

Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the toxicity of anti-IL-5 in patients with hypereosinophilia 28 weeks
Secondary To assess whether anti-IL-5 lowers peripheral blood eosinophils and/or tissue in patients with hypereosinophilia 28 weeks
Secondary To assess whether anti-IL-5 has a steroid and/or interferon sparing effect 28 weeks
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