Efficacy and Safety of Orally Administered DS102 in Patients With Acute Alcoholic Hepatitis
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|ClinicalTrials.gov Identifier: NCT03452540|
Recruitment Status : Not yet recruiting
First Posted : March 2, 2018
Last Update Posted : November 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Severe Acute Decompensated Alcoholic Hepatitis||Drug: DS102 Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS102 in Patients With Acute Decompensated Alcoholic Hepatitis.|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||February 2020|
Participants in this group will receive 2000mg DS102 capsules daily.
Participants will receive 1000mg DS102 capsules twice per day.
Placebo Comparator: Placebo
Participants in this group will receive placebo capsules daily.
Participants will receive placebo capsules twice per day.
- % change in model for end-stage liver disease (MELD) score from baseline [ Time Frame: 28 days ]
- Change in serum bilirubin [ Time Frame: 28 days ]
- Change in aspartate aminotransferase (AST) levels [ Time Frame: 28 days ]
- Change in AST:ALT (alanine transaminase) ratio [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452540
|Contact: Karen Doyleemail@example.com|
|Contact: Markus Weissbach||+3532946380|