Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis
NCT00035334 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2006-02-14
Summary
The main objective of this study is to evaluate the safety and efficacy of NC-503 compared to placebo in patients with secondary (AA) amyloidosis using a composite assessment of clinical improvement/worsening of both renal and gastrointestinal functions.
Conditions
- Secondary (AA) Amyloidosis
- Rheumatoid Arthritis
- Nephrotic Syndrome
- Familial Mediterranean Syndrome
- Kidney Diseases
- Gastrointestinal Diseases
Interventions
- DRUG
-
NC-503 (Anti-amyloidotic (AA) Agent)
Sponsors & Collaborators
-
FDA Office of Orphan Products Development
collaborator FED -
Bellus Health Inc. - a GSK company
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-10-31
- Completion
- 2004-12-31
Countries
- United States
- Finland
- France
- Israel
- Italy
- Lithuania
- Netherlands
- Poland
- Russia
- Spain
- Turkey (Türkiye)
- United Kingdom
Study Locations
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