Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035334
Status:
COMPLETED
Last Update Posted:
2006-02-14
First Post:
2002-05-02
Brief Title:
Study of the Safety and Efficacy of NC-503 in Secondary AA Amyloidosis
Sponsor:
Bellus Health Inc - a GSK company
Organization:
Bellus Health Inc - a GSK company
Study Overview
Official Title:
A Phase IIIII Study of the Safety and Efficacy of NC-503 in Patients Suffering From Secondary AA Amyloidosis
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 improvementworsening of both renal and gastrointestinal functions
Detailed Description:
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 IIIII 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None