drugset / Trial / NCT01917630
Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.
Timeline
- Start
- 2013-08
- Primary completion
- 2015-04
- Completion
- 2015-06
Outcome
Missed primary endpoint
paper In a modified intent-to-treat population, there were no differences between latiglutenase and placebo groups in change from baseline in villous height:crypt depth ratio PMID 27864127 ↗
Publications
- Syage JA, Murray JA, Green PHR, Khosla C. Latiglutenase Improves Symptoms in Seropositive Celiac Disease Patients While on a Gluten-Free Diet. Dig Dis Sci. 2017 Sep;62(9):2428-2432. doi: 10.1007/s10620-017-4687-7. Epub 2017 Jul 28.
- Murray JA, Kelly CP, Green PHR, Marcantonio A, Wu TT, Maki M, Adelman DC; CeliAction Study Group of Investigators. No Difference Between Latiglutenase and Placebo in Reducing Villous Atrophy or Improving Symptoms in Patients With Symptomatic Celiac Disease. Gastroenterology. 2017 Mar;152(4):787-798.e2. doi: 10.1053/j.gastro.2016.11.004. Epub 2016 Nov 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Latiglutenase | Protein / enzyme biologic | 100 mg | Oral |
| Subject | Latiglutenase | Protein / enzyme biologic | 300 mg | Oral |
| Subject | Latiglutenase | Protein / enzyme biologic | 450 mg | Oral |
| Subject | Latiglutenase | Protein / enzyme biologic | 600 mg | Oral |
| Subject | Latiglutenase | Protein / enzyme biologic | 900 mg | Oral |