Trials / Unknown
UnknownNCT01917630
Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Alvine Pharmaceuticals Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALV003 | ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase) |
| DRUG | placebo |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2015-04-01
- Completion
- 2015-06-01
- First posted
- 2013-08-07
- Last updated
- 2014-12-17
Locations
88 sites across 6 countries: United States, Canada, Finland, Ireland, Norway, United Kingdom
Source: ClinicalTrials.gov record NCT01917630. Inclusion in this directory is not an endorsement.