| Trial ID: | L0329 |
| Source ID: | NCT02653300
|
| Associated Drug: |
Insulin
|
| Title: |
A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT02653300/results
|
| Conditions: |
Non-Alcoholic Steatohepatitis (NASH)|Type2 Diabetes Mellitus
|
| Interventions: |
Biological: Oral Insulin
|
| Outcome Measures: |
Change in MRI-Proton Density Fat Fraction (MRI-PDFF)|Mean Transient Elastography Measurement (Fibroscan)|Mean Fibrosis Score CAP??? (FibroMax)
|
| Sponsor/Collaborators: |
Oramed, Ltd.|Hadassah Medical Organization
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
10
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
September 20, 2018
|
| Completion Date: |
April 1, 2020
|
| Results First Posted: |
September 23, 2021
|
| Last Update Posted: |
September 23, 2021
|
| Locations: |
Hadassah Medical Center, Jerusalem, Israel
|
| URL: |
https://ClinicalTrials.gov/show/NCT02653300
|
