Clinical Trials Logo
  1. Home
  2. Celiac Disease
  3. NCT00859391

Effects of Gluten Digestion With ALV003 — 0801  

Celiac Disease Clinical Trial

Official title:
A Phase 0 Study in Subjects With Well Controlled Celiac Disease to Assess the Effects of Gluten Digestion With ALV003 (a Protease Enzyme) in Vitro

Clinical Trial Summary

This is a Phase 0, Double-blind study that will assess the effect of in vitro treatment of gluten with ALV003 or with placebo when ingested by CD Subjects.

Clinical Trial Description

The primary objective of this study is to compare the effects of gluten treated with ALV003 vs placebo:

- The clinical response by symptom measurement before and after oral challenge

- The immune response measured by ELISPOT testing and serology The secondary objective of the study is to

- Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00859391
Study type Observational
Source Alvine Pharmaceuticals Inc.
Contact
Status Completed
Phase Phase 0
Start date May 2008
Completion date June 2008
View Details
See also
  Status Clinical Trial Phase
Completed NCT04349904 - Near-Focus NBI Classification of Villous Atrophy in Suspected Coeliac Disease: International Development and Validation
Recruiting NCT05581628 - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Completed NCT04593251 - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis Phase 1
Completed NCT05810441 - Intestinal Transglutaminase Antibodies in Celiac Disease Diagnosis
Recruiting NCT05555446 - Bovine Colostrum to Prevent Absorption of Gluten Early Phase 1
Completed NCT02754609 - Hookworm Therapy for Coeliac Disease Phase 1
Terminated NCT01902368 - Celiac Disease Screening N/A
Completed NCT02472704 - Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo N/A
Completed NCT02312349 - Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
Completed NCT01172665 - Celiac Disease Database
Completed NCT01100099 - HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease Phase 2/Phase 3
Completed NCT00639444 - Risk of Celiac Disease and Age at Gluten Introduction N/A
Active, not recruiting NCT05425446 - Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients Phase 1
Enrolling by invitation NCT02202681 - Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule N/A
Completed NCT00362856 - Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects Phase 2
Terminated NCT03866538 - Budesonide in Patients With Immune Mediated Enteropathies Phase 4
Recruiting NCT05135923 - Glutenfree, Gut Microbiota and Metabolic Regulation N/A
Completed NCT05052164 - Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women N/A
Completed NCT03775499 - Probiotic BL NCC 2705 and Gluten Sensitivity N/A
Completed NCT03707730 - A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease Phase 2