Detailed Result for NCT03201159
NCT ID: | NCT03201159 |
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NLM Download Date Description: | N/A |
Study First Submitted Date: | 2017-03-24 |
Last Update Submitted Date: | 2018-05-25 |
Last Update Submitted Date: | 2018-05-25 |
Result First Submitted Date: | N/A |
Disposition First Submitted Date: | N/A |
Start Month Year: | June 25, 2017 |
Start Date: | 2017-06-25 |
Start Date Type: | Actual |
Verification Month Year: | May 2018 |
Verification Date: | 2018-05-31 |
Completion Month Year: | February 27, 2018 |
Completion Date: | 2018-02-27 |
Completion Date Type: | Actual |
Primary Completion Month Year: | February 27, 2018 |
Primary Completion Date: | 2018-02-27 |
Primary Completion Date Type: | Actual |
Study first Submitted QC Date: | 2017-06-23 |
Study first posted Date: | 2017-06-28 |
Result first Submitted QC Date: | N/A |
Result First Posted Date: | N/A |
Disposition First Submitted QC Date: | N/A |
Disposition First Posted Date: | N/A |
Last Updated Submitted QC Date: | 2018-05-25 |
Last Updated Posted Date: | 2018-05-30 |
Target Duration: | N/A |
Study Type: | Interventional |
Acronym: | N/A |
Baseline Population: | N/A |
Brief Title: | A Pilot, Dose Escalating Study on VLX103 in Moderate Alcoholic Steatohepatitis |
Official Title: | A Pilot, Exploratory Dose Escalating Study on the Safety, Pharmacodynamics and Preliminary Efficacy of VLX103 in the Treatment of Moderate Alcoholic Steatohepatitis |
Overall Status: | Withdrawn |
Last Known Status: | N/A |
Phase: | Phase 1 |
Enrollment: | N/A |
Enrollment Type: | Actual |
Source: | University of Massachusetts, Worcester |
Limitation and Caveats: | N/A |
Number of Arms: | 3 |
Number of Groups: | N/A |
Why Stopped: | Drug manufacturer ceased operations |
Has Expanded Access: | N/A |
Expanded Access Type Individual: | N/A |
Expanded Access Type Intermediate: | N/A |
Expanded Access Type Treatment: | N/A |
Has DMC: | true |
Is it FDA Regulated Drug: | true |
Is it FDA Regulated Device: | N/A |
Is it Unapproved Device: | N/A |
Is PPSD: | N/A |
Is US Export: | N/A |
Is Biospec Retention: | N/A |
Biospec Description: | N/A |
Plan to Share IPD: | Yes |
Plan to Share IPD Description: | Data will be filtered through Data Coordinating Center |
IPD Time Frame: | N/A |
IPD Access Criteria: | N/A |
IPD URL: | N/A |