| Trial ID: | L0333 |
| Source ID: | NCT01205087
|
| Associated Drug: |
OKT3
|
| Title: |
Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: OKT3
|
| Outcome Measures: |
This clinical study is designed to evaluate the safety and the immune-modulatory effects of oral administration of the study drug anti-CD3 MAb to subjects with the metabolic syndrome.|This clinical study also will include evaluations for markers of efficacy, as described below.
|
| Sponsor/Collaborators: |
Hadassah Medical Organization|NasVax Ltd
|
| Gender: |
All
|
| Age: |
18 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
36
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
|
| Start Date: |
September 2010
|
| Completion Date: |
April 2011
|
| Results First Posted: |
--
|
| Last Update Posted: |
June 23, 2011
|
| Locations: |
Hadassah University Hospital, Liver Unit, Jerusalem, Israel
|
| URL: |
https://ClinicalTrials.gov/show/NCT01205087
|