Trial Outcomes & Findings for Use of F-652 in Patients With Alcoholic Hepatitis (NCT NCT02655510)
NCT ID: NCT02655510
Last Updated: 2019-09-09
Results Overview
The count of subjects who experience serious adverse events
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
From day 1 up to 42 days following administration of last dose of study drug
Results posted on
2019-09-09
Participant Flow
Participant milestones
| Measure |
Period 1: F-652 10 μg/kg
Participants will receive 10 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
|
Period 2: F-652 30 μg/kg
Participants will receive 30 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
|
Period 3: F-652 45 μg/kg
Participants will receive 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
Baseline characteristics by cohort
| Measure |
Period 1: F-652 10 μg/kg
n=6 Participants
Participants will receive 10 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
|
Period 2: F-652 30 μg/kg
n=6 Participants
Participants will receive 30 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion
|
Period 3: F-652 45 μg/kg
n=6 Participants
Participants will receive 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 6.9 • n=6 Participants
|
50.5 years
STANDARD_DEVIATION 12.0 • n=6 Participants
|
50.3 years
STANDARD_DEVIATION 11.3 • n=6 Participants
|
49.1 years
STANDARD_DEVIATION 9.8 • n=18 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
12 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
17 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
18 participants
n=18 Participants
|
|
Alcohol Consumption by MELD grouping
MELD 11-20
|
143.3 grams per day
STANDARD_DEVIATION 75.0 • n=3 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
151.3 grams per day
STANDARD_DEVIATION 28.8 • n=3 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
186.6 grams per day
STANDARD_DEVIATION 88.9 • n=3 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
160.4 grams per day
STANDARD_DEVIATION 63.1 • n=9 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
|
Alcohol Consumption by MELD grouping
MELD 21-28
|
181.3 grams per day
STANDARD_DEVIATION 140.0 • n=3 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
212.6 grams per day
STANDARD_DEVIATION 141.7 • n=3 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
57.3 grams per day
STANDARD_DEVIATION 28.0 • n=3 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
150.4 grams per day
STANDARD_DEVIATION 123.2 • n=9 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
|
Hospitalized at screening by MELD grouping
MELD 11-20
|
3 Participants
n=3 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
3 Participants
n=3 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
2 Participants
n=3 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
8 Participants
n=9 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
|
Hospitalized at screening by MELD grouping
MELD 21-28
|
1 Participants
n=3 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
1 Participants
n=3 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
3 Participants
n=3 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
5 Participants
n=9 Participants • The six participants in each period were further defined by MELD grouping, where three participants had a MELD score of 11-20 and three participants had a MELD score of 21-28; resulting in a total of six participants in each period, a total of 18 subjects overall.
|
PRIMARY outcome
Timeframe: From day 1 up to 42 days following administration of last dose of study drugThe count of subjects who experience serious adverse events
Outcome measures
| Measure |
Period 1: F-652 10 μg/kg
n=6 Participants
Participants will receive 10 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
|
Period 2: F-652 30 μg/kg
n=6 Participants
Participants will receive 30 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
|
Period 3: F-652 45 μg/kg
n=6 Participants
Participants will receive 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
|
|---|---|---|---|
|
The Number of Subjects With Unexpected Serious Adverse Events.
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Period 1: F-652 10 μg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Period 2: F-652 30 μg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
Period 3: F-652 45 μg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Period 1: F-652 10 μg/kg
n=6 participants at risk
Participants will receive 10 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
|
Period 2: F-652 30 μg/kg
n=6 participants at risk
Participants will receive 30 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
|
Period 3: F-652 45 μg/kg
n=6 participants at risk
Participants will receive 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
33.3%
2/6 • Number of events 3 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
|
Investigations
Leukocytosis
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
|
General disorders
Fever
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
|
General disorders
Nausea
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
|
Cardiac disorders
Hypertension
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
|
General disorders
Tremors
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
|
General disorders
Muscle Weakness
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
|
General disorders
Increased body temperature
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
|
General disorders
Thrombocytosis
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
0.00%
0/6 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected up to 42 days following the last administration of study treatment for each subject, an average of 56 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place