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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marc Rothenberg, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00266565
First received: December 15, 2005
Last updated: October 22, 2013
Last verified: October 2013

December 15, 2005
October 22, 2013
December 2001
July 2012   (final data collection date for primary outcome measure)
To assess the toxicity of anti-IL-5 in patients with hypereosinophilia [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]
To assess the toxicity of anti IL-5 in patients with hypereosinophilia
Complete list of historical versions of study NCT00266565 on ClinicalTrials.gov Archive Site
  • To assess whether anti-IL-5 lowers peripheral blood eosinophils and/or tissue in patients with hypereosinophilia [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • To assess whether anti-IL-5 has a steroid and/or interferon sparing effect [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • To assess whether anti-IL-5 lowers peripheral blood eosinophils and/ or tissue in patients with hypereosinophilia
  • To assess whether anti-IL5 has a steroid and/or interferon sparing effect
Not Provided
Not Provided
 
Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome
A Phase I/II Study of the Effect of Intravenous Anti-IL-5 (Mepolizumab) SB 240563 on the Outcome and Management of Hypereosinophilic Syndromes

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypereosinophilic Syndromes
  • Eosinophilic Gastroenteritis
  • Churg-Strauss Syndrome
  • Eosinophilic Esophagitis
Drug: Mepolizumab
10mg/kg (max 750 ml) once a month for 3 months
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00266565
01-9-18, FD-R-002396
Yes
Marc Rothenberg, Children's Hospital Medical Center, Cincinnati
Marc Rothenberg
Not Provided
Principal Investigator: Marc E. Rothenberg, MD Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP