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Sponsors and Collaborators: |
Bellus Health Inc FDA Office of Orphan Products Development |
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Information provided by: | Bellus Health Inc |
ClinicalTrials.gov Identifier: | NCT00035334 |
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.
Condition | Intervention | Phase |
---|---|---|
Secondary (AA) Amyloidosis Rheumatoid Arthritis Nephrotic Syndrome Familial Mediterranean Syndrome Kidney Diseases Gastrointestinal Diseases |
Drug: NC-503 (Anti-amyloidotic (AA) Agent) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II/III Study of the Safety and Efficacy of NC-503 in Patients Suffering From Secondary (AA) Amyloidosis |
Estimated Enrollment: | 150 |
Study Start Date: | October 2001 |
Estimated Study Completion Date: | December 2004 |
AA amyloidosis is associated with chronic inflammatory conditions (rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease), chronic infection (tuberculosis, osteomyelitis), and Familial Mediterranean Fever. Rheumatoid arthritis is the major cause of AA amyloidosis in Western Europe and North America. The most common clinical feature of AA amyloidosis is renal dysfunction manifested as nephrotic-range proteinuria or renal insufficiency at the time of diagnosis. End-stage renal failure is the cause of death in 40-60% of cases. Gastrointestinal involvement is also frequent and is usually manifested as chronic diarrhea, body weight loss and malabsorption. Enlargement of the liver and spleen may also occur in some patients. The median survival time from diagnosis varies from 2 to 8 years depending on the stage of the disease at time of diagnosis. The goal of the current therapy in AA amyloidosis is the control of the associated disease. However, the current approaches for the treatment of AA amyloidosis are unspecific, toxic, invasive, and not sufficiently effective in many cases. NC-503 was specifically designed to compete with the naturally occurring sulfated GAGs for the binding to amyloidogenic precursor proteins, and to inhibit amyloid deposition into tissues. The proposed therapy with NC-503 is based on the prevention of the amyloid fibril formation. The objective of this clinical phase II/III study is to determine the efficacy and safety of NC-503 compared to a placebo in patients suffering from secondary (AA) amyloidosis by the assessment of clinical improvement/ worsening of both renal and gastrointestinal functions.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL INCLUSION CRITERIA
PROTOCOL EXCLUSION CRITERIA
Study ID Numbers: | CL-503004 |
Study First Received: | May 2, 2002 |
Last Updated: | February 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00035334 |
Health Authority: | United States: Food and Drug Administration |
Familial Mediterranean Fever Amyloidosis Secondary (AA) Amyloidosis Nephrotic Syndrome |
Autoimmune Diseases Metabolic Diseases Gastrointestinal Diseases Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Fever Familial Mediterranean fever Nephrosis Amyloidosis Digestive System Diseases |
Urologic Diseases Musculoskeletal Diseases Arthritis Connective Tissue Diseases Neoplasm Metastasis Kidney Diseases Metabolic disorder Brucellosis Familial Mediterranean Fever Nephrotic Syndrome |
Neoplasms Neoplastic Processes Disease |
Pathologic Processes Immune System Diseases Syndrome |