Track topics on Twitter Track topics that are important to you
A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.
Double-blind, placebo controlled study of the efficacy, safety and tolerability of 6-weeks treatment of ALV003 in patients with well-controlled celiac disease. Approximately 110 biopsy proven celiac disease patients will be randomized to treatment with ALV003 or placebo in a 1:1 ratio. Patients will be required to have a pre-dose and a post-treatment intestinal biopsy, and also will be required to ingest a foodstuff that contains a specified amount of gluten during the active phase of the study along with the study treatment. Patients will return to the clinic weekly for the first two weeks, then every two weeks thereafter for safety visits. Patients will return to the clinic 28 days after completion of treatment for final safety and follow-up. Safety will be closely monitored throughout the study including laboratory parameters and clinical assessment of adverse events.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ALV003, ALV003 placebo
FINN-MEDI Research - Clinical Trials Center
Alvine Pharmaceuticals Inc.
Published on BioPortfolio: 2014-08-27T03:20:02-0400
ALV003-0812 is a study of the safety and tolerability of a study drug (ALV003) in healthy adult volunteers and in patients with well-controlled celiac disease, following a meal that contai...
A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).
This study is to see if a high response to the TTG screening test for celiac disease is as accurate as the current method of diagnosing celiac disease which entails a general anesthetic an...
Background/Aim: Celiac disease is a common immune-mediated disorder, and the only currently available treatment is a gluten-free diet. Recent studies have shown several probiotics to carry...
A randomized, double-blind, placebo-controlled clinical study in non-homozygous human leukocyte antigen (HLA)-DQ.2.5+ adults with celiac disease (CeD).
To identify additional celiac disease associated loci in the Major Histocompatibility Complex independent from classical HLA risk alleles (HLA-DR3-DQ2) and to characterize their potential functional i...
Celiac disease and wheat allergy (WA) are infrequent diseases in the general population, and a combination of the 2 is particularly rare. Celiac disease occurs in around 1% of the general population a...
Celiac disease is an enteropathy caused by dietary gluten. The combination of serologic, genetic and histologic data has led to description of other categories of this disease.
Given the increased morbidity and potential mortality of celiac disease, guidelines recommend screening high-risk individuals, including first-degree relatives of patients. We assessed how commonly ce...
Celiac disease is an autoimmune enteropathy triggered by the ingestion of gluten in genetically susceptible individuals. Almost all celiac patients carry immune recognition genes coding for HLA-DQ2.5 ...
A complex network of nerve fibers including sympathetic and parasympathetic efferents and visceral afferents. The celiac plexus is the largest of the autonomic plexuses and is located in the abdomen surrounding the celiac and superior mesenteric arteries.
Simple protein, one of the prolamines, derived from the gluten of wheat, rye, etc. May be separated into 4 discrete electrophoretic fractions. It is the toxic factor associated with CELIAC DISEASE.
Human immune-response, D-related antigen encoded by the D locus on chromosome 6 and found on lymphoid cells. It is in linkage disequilibrium with HLA-A1 and HLA-B8. The HLA-DR3 antigen is strongly associated with celiac disease, Grave's disease, dermatitis herpetiformis, early-age onset myasthenia gravis, systemic lupus erythematosus, juvenile diabetes, and opportunistic infections in AIDS.
Human immune-response, D-related antigen encoded by the D locus on chromosome 6 and found on lymphoid cells. It is strongly associated with celiac disease and psoriasis vulgaris.
A malabsorption syndrome that is precipitated by the ingestion of GLUTEN-containing foods, such as wheat, rye, and barley. It is characterized by INFLAMMATION of the SMALL INTESTINE, loss of MICROVILLI structure, failed INTESTINAL ABSORPTION, and MALNUTRITION.
Astroesophageal Reflux Disease (GERD) Barrett's Esophagus Celiac Disease Cholesterol Crohn's Disease Gastroenterology Hepatitis Hepatology Irritable Bowel Syndrome (IBS) Pancreatitis Peptic Ulcer Disease...
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...