Spots Global Cancer Trial Database for Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis
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Trial Identification
Brief Title: Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis
Official Title: A Phase II/III Study of the Safety and Efficacy of NC-503 in Patients Suffering From Secondary (AA) Amyloidosis
Study ID: NCT00035334
Interventions
Study Description
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 improvement/worsening 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 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Indiana University School of Medicine, Department of Pathology and Laboratory Medicine,, Indianapolis, Indiana, United States
Boston Medical Center, Renal Division, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Mount Sinai Medical Center, New York, New York, United States
Rheumatism Foundation Hospital, Heinola, , Finland
Centre Hospitalier du Mans, Service de Rhumatologie, Le Mans, , France
Hôpital Claude Huriez, Service de médecine Interne, Clinique Médicale A, Lille, , France
Hôpital Cochin, Centre de Recherche et d'Explorations Fonctionnelles, Paris, , France
Bnai Zion Medical Center, Haifa, , Israel
Heller Institute of Medical Research, Sheba Medical Center, Tel Hashomer, , Israel
Italian Group for Systemic Amyloidosis, Biotechnology Research Laboratories, IRCCS Policlinico San Matteo, Internal Medicine and Medical Oncology, Pavia, , Italy
Vilnius University Hospital, Vilnius, , Lithuania
University Hospital Groningen, Department of Medicine, Division of Rheumatology, Groningen, , Netherlands
Instytut Reumatologiczny, Warszawa, , Poland
Okregowy Szpital Kolejowy, Zaklad Reumatologii, Wroclaw, , Poland
Institute of Rheumatology RAMS, Moscow, , Russian Federation
Regional Hospital No. 1, Yekaterinburg, , Russian Federation
Hospital Universitario Germans Trias I Pujol, Servicio de Reumatologia, Badalona, , Spain
Hospital Clinic I Provincial de Barcelona, Jefe del Departamento de Reumatologia, Barcelona, , Spain
Ciutad Sanitària y Universitària de Bellvitge, Servicio de Reumatologia, Hospitalet de Llobregat, Llobregat, , Spain
Hospital Clinico San Carlos de Madrid, Servicio de Reumatologia, Madrid, , Spain
Cerrehpasa Tip Fakultesi, Askaray, Istanbul, Turkey, , Turkey
Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Istanbul, , Turkey
Marmara University Medical School Hospital, Department of Rheumatology, Uskudar, Altunizade, Istanbul, , Turkey
Royal Free and University College Medical School, Department of Medicine, National Amyloidosis Centre, London, , United Kingdom
Gartnavel General Hospital, Scotland, , United Kingdom
Contact Details
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