Trial Outcomes & Findings for Efficacy and Safety of Orally Administered DS102 in Patients With Acute Alcoholic Hepatitis (NCT NCT03452540)
NCT ID: NCT03452540
Last Updated: 2022-07-29
Results Overview
To evaluate the safety of orally administered DS102 in the treatment of adult patients with severe acute decompensated AH.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 28 days.
Results posted on
2022-07-29
Participant Flow
This was a multicentre, double blind, placebo controlled, 2-arm parallel group comparison (Phase 2) study, preceded by an open label pilot phase, in which six patients were to receive open label treatment with 2000mg DS102 (1000mg BID) within 30 minutes after a meal for 28 days.
A total of 126 participants were planned with actual enrolment in the study. 9 participants completed the open label pilot phase before the study was ended prematurely due to futility purposes.
Participant milestones
| Measure |
1000mg DS102 (BID)
Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
1000mg DS102 (BID)
Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Other SAE and AE
|
2
|
Baseline Characteristics
Efficacy and Safety of Orally Administered DS102 in Patients With Acute Alcoholic Hepatitis
Baseline characteristics by cohort
| Measure |
1000mg DS102 (BID)
n=9 Participants
Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.
|
|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days.Population: The Full Analysis Set (FAS) included all patients who received at least one dose of investigational product. Patients were analysed according to the treatment they were assigned to, irrespective of what treatment they actually received.
To evaluate the safety of orally administered DS102 in the treatment of adult patients with severe acute decompensated AH.
Outcome measures
| Measure |
1000mg DS102 (BID)
n=9 Participants
Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.
|
|---|---|
|
Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and SUSARs.
Total Number of TEAEs
|
7 Number of Events
|
|
Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and SUSARs.
Total Number of Serious TEAEs
|
4 Number of Events
|
|
Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and SUSARs.
Total Number of Serious Treatment Related TEAEs
|
1 Number of Events
|
|
Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and SUSARs.
Total Number of Treatment Related TEAEs
|
1 Number of Events
|
|
Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and SUSARs.
Total Number of Not Treatment Related TEAEs
|
6 Number of Events
|
PRIMARY outcome
Timeframe: Up to 7 daysPopulation: The Full Analysis Set (FAS) included all patients who received at least one dose of investigational product. Patients were analysed according to the treatment they were assigned to, irrespective of what treatment they actually received.
Descriptive Statistics for Plasma Total 15(S)-HEPE and Unesterified 15(S)-HEPE Pharmacokinetic Results for 1000 mg BD DS102 Administered Orally Twice-daily to Patients with Alcoholic Hepatitis.
Outcome measures
| Measure |
1000mg DS102 (BID)
n=9 Participants
Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.
|
|---|---|
|
Descriptive Statistics for Plasma Total 15(S)-HEPE and Unesterified 15(S)-HEPE Pharmacokinetic Results for 1000 mg BD DS102 Administered Orally Twice-daily to Patients With Alcoholic Hepatitis
Day 7 Total 15(S)-HEPE
|
4470 ng/mL
Standard Deviation 3601
|
|
Descriptive Statistics for Plasma Total 15(S)-HEPE and Unesterified 15(S)-HEPE Pharmacokinetic Results for 1000 mg BD DS102 Administered Orally Twice-daily to Patients With Alcoholic Hepatitis
Day 0 Unesterified 15(S)-HEPE
|
542 ng/mL
Standard Deviation 399.4
|
|
Descriptive Statistics for Plasma Total 15(S)-HEPE and Unesterified 15(S)-HEPE Pharmacokinetic Results for 1000 mg BD DS102 Administered Orally Twice-daily to Patients With Alcoholic Hepatitis
Day 7 Unesterified 15(S)-HEPE
|
1060 ng/mL
Standard Deviation 1073
|
|
Descriptive Statistics for Plasma Total 15(S)-HEPE and Unesterified 15(S)-HEPE Pharmacokinetic Results for 1000 mg BD DS102 Administered Orally Twice-daily to Patients With Alcoholic Hepatitis
Day 0 Total 15(S)-HEPE
|
3110 ng/mL
Standard Deviation 3721
|
Adverse Events
1000mg DS102 (BID)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
1000mg DS102 (BID)
n=9 participants at risk
Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.
|
|---|---|
|
Cardiac disorders
Cardiac Arrest
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Infections and infestations
Septic Shock
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Nervous system disorders
Metabolic encephalopathy
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
General disorders
Multiple organ dysfunction syndrome
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Psychiatric disorders
Mental status change
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Renal and urinary disorders
Renal Failure
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Vascular disorders
Hypovolaemic Shock
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
Other adverse events
| Measure |
1000mg DS102 (BID)
n=9 participants at risk
Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
22.2%
2/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Gastrointestinal disorders
Glossitis
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
General disorders
Asthenia
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
General disorders
Localised Oedema
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
General disorders
Oedema
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
General disorders
Oedema Peripheral
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Investigations
Aspartate Aminotransferase increased
|
22.2%
2/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Investigations
Blood Alkaline phosphate increased
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Investigations
Paracentesis
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Injury, poisoning and procedural complications
Fall
|
22.2%
2/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Injury, poisoning and procedural complications
Head Injury
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Nervous system disorders
Encephalopathy
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Psychiatric disorders
Confusional State
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
11.1%
1/9 • Up to 90 days.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational medicinal product (IMP). All Adverse Events (AEs) were recorded in the CRF, defining relationship to IMP and severity.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place