Status:
COMPLETED
STA-5326 Meslylate to Treat Gut Inflammation Associated With Common Variable Immunodeficiency
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Common Variable Immunodeficiency
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study will determine whether an experimental medicine, STA-5326 mesylate, is safe to use in patients with common variable immunodeficiency (CVID) who have inflammation of the gut. It will also de...
Detailed Description
The purpose of this study is to assess the toxicity of the oral IL-12/23 inhibitor STA-5326 mesylate in subjects with common variable immunodeficiency (CVID) and associated symptomatic gastrointestina...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A subject is eligible for the study if all of the following criteria are met:
- Has given written informed consent prior to screening.
- Is male or female aged 18 through 75 years.
- Has CVID diagnosed definitively prior to screening (based on the IUIS criteria).
- Has a documented, unintended loss of greater than 5% of their body weight over the last year or requires nutritional supplements to maintain his/her body weight OR has chronic diarrhea defined as a complaint of liquid stools for at least 4 consecutive weeks (and an output of greater than 200 g stool/24hr on a diet of at least 1600 calories with 60 g fat.)
- If taking oral antibiotics chronically, must have used a stable dose of the antibiotic continuously for at least 2 weeks prior to start of screening period.
- Not taking any potential CYP3A4 inhibitors/inducers (e.g., macrolide antibiotics, HIV protease inhibitors, antifungals, grapefruit juice, St. John's Wort).
- EXCLUSION CRITERIA:
- A subject is excluded from the study if any of the following criteria are met:
- General Criteria:
- Has any clinically significant disease (e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that in the opinion of the investigator would make the subject an unsuitable candidate for this trial.
- Is a woman who has a positive serum pregnancy test or who is breast-feeding.
- Is a woman of childbearing potential or a man who does not agree to use two forms of contraception during the course of the study and follow-up period.
- Has hypersensitivity to any of the components of STA 5326 mesylate drug product.
- Has any of the following clinical chemistry values:
- AST greater than 2.5 x upper limit of normal (ULN).
- ALT greater than 2.5 x ULN.
- Serum bilirubin greater than 1.5 x ULN.
- Serum creatinine greater than 1.5 x ULN.
- Alkaline phosphatase greater than 2.5 x ULN.
- Has a hemoglobin level less than 9 g/dL or hematocrit less than 30%.
- Has a Prothromin Time INR greater than 1.3 or a Partial Thromboplastin Time greater than 3 sec compared to control value.
- Has the following cell counts (cells/microliter):
- Platelet count less than 90,000 or greater than 800,000.
- White blood cell count less than 1,500.
- Neutrophil count less than 900.
- Has a current infection requiring intravenous antibiotics, a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia).
- Has a history of cancer within the past 5 years, with the exception of excised basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
- Had a dependency for any illicit drug, chemical, or alcohol within the past 5 years.
- Has a history of active tuberculosis (or a CXR with findings suggestive of old TB infection including calcified nodular lesions, apical fibrosis, or pleural scarring), acute or chronic hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- Gastrointestinal Criteria:
- Has a stool sample positive for gastrointestinal infection during screening.
- Has a positive hydrogen breath test
- Prior Medication Criteria:
- Received parenteral corticosteroids within 1 month prior to receiving study drug. The use of short-term or single-dose corticosteroids as a pretreatment regimen for IVIG is acceptable.
- Received any investigational drug within 3 months prior to receiving study drug.
- Received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 2 months prior to receiving study drug.
- Received any biological product (e.g., infliximab, adalimumab, natalizumab, etc.) within 3 months prior to receiving study drug.
- Ever received treatment with STA-5326 mesylate, anti-IL 12 antibodies, or other specific IL 12 inhibitors.
Exclusion
Key Trial Info
Start Date :
December 2 2005
Trial Type :
INTERVENTIONAL
End Date :
July 23 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00263237
Start Date
December 2 2005
End Date
July 23 2008
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892