celiac disease
Conditions
Interventions
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:
Exclusion criteria
Exclusion criteria: 1.History of known Immunoglobulin E -mediated reaction to wheat, barley or Rye 2.Unable to provide documentation of duodenal histology that reports villous atrophy, and of elevated serum transglutaminase-specific IgA, IgA endomysial immunofluorescence (EMA), or for IgA deficient individuals then DGP IgG. 3.Medication within 3 months that might suppress cellular immunity (e.g. oral or parental corticosteroids, immunosuppressive medication) 4.Any medical condition that in the opinion of the investigator may interfere with study conduct. 5.Any medical condition that in the opinion of the investigator would impact the immune response, confound interpretation of study results, or pose an increased risk to the patient. 6.Haemoglobin level or platelet count at screening that is outside the normal gender-specific and age-specific range 7.Individual has uncontrolled medical conditions that in the opinion of the investigator, would increase the risk of blood collection to the patient. For guidance see American Red Cross Blood Donation eligibility criteria 8.Blood donation (one unit of blood) within the previous 8 weeks. 9.Heart disease with heart related symptoms. 10.Heart murmur, or heart valve disorder that has not been medically evaluated, or has caused symptoms within the last 6 months, and is associated with restrictions on normal daily activities. 11.Any medical condition or therapy resulting in impaired blood clotting and bleeding. 12.Body weight less than 50 kg. 13.The pregnant. 14.Vital signs outside the range: systolic blood pressure 90 to 180 mm Hg, diastolic blood pressure 60 to 100 mm Hg, pulse rate regular and 50 to 100 per minute, or body temperature exceeding 99.5oF.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ELISPOT assay | — |
Countries
Australia
Contacts
Public ContactYosuke Murakami
Chugai Pharmaceutical Co., Ltd. Early Clinical Development Dept.
Outcome results
None listed