Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00017862
• Date of registration: 15/06/2001
• Prospective Registration: No
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome
• Scientific title: A Pilot Phase II Study of the Efficacy of Humanized Anti-IL5 Antibody (SCH55700) in Reducing Eosinophilia in Patients With Hypereosinophilic Syndrome or Eosinophilic Gastroenteritis Refractory to or Intolerant of Conventional Therapy
• Date of first enrolment: June 2001
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00017862
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

INCLUSION CRITERIA - HES:

All subjects must meet the established diagnostic criteria for idiopathic
hypereosinophilic syndrome: eosinophilia greater than 1,500/mm3 on two occasions at least
6 months apart, no known etiology for the eosinophilia despite careful clinical
evaluation, evidence of end organ damage (histologic evidence of tissue infiltration by
eosinophils and/or objective evidence of clinical pathology in any organ system that is
temporarily associated with eosinophilia and not clearly attributable to another cause).

All subjects must be at least 18 years of age.

Failure of or contraindication to treatment with steroids, interferon alpha and
hydroxyurea

Negative serum beta-hCG within 24 hours of drug administration for women of childbearing
potential must to exclude early pregnancy

Agree to practice abstinence or effective contraception for 6 months following
administration of the study drug

INCLUSION CRITERIA - EG:

All subjects must meet the established diagnostic criteria for eosinophilic
gastroenteritis: gastrointestinal symptoms, histologic evidence of gastrointestinal
tissue infiltration by eosinophils with greater than or equal to 25 eosinophils per high
powered field, no known etiology for the eosinophilia despite careful clinical evaluation

Eosinophilia greater than 860/mm3 on two occasions at least 6 months apart

Evidence of hypersensitivity to foods or aeroallergens as determined by skin or RAST
testing

All subjects must be at least 18 years of age.

Failure of or contraindication to treatment with steroids.

Negative serum beta-hCG within 24 hours of drug administration for women of childbearing
potential must to exclude early pregnancy

Agree to practice abstinence or effective contraception for 6 months following
administration of the study drug

EXCLUSION CRITERIA - HES and GE:

Pregnant or nursing women

HIV positivity or other known immunodeficiency

Use of any other investigational agent within 30 days of the study

Any condition that, in the investigator's opinion, places the patient at undue risk by
participating in the study.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hypereosinophilic Syndrome

Intervention(s)

Drug: SCH55700

Secondary ID(s)

01-I-0155

010155

Source(s) of Monetary Support

Please refer to primary and secondary sponsors