Trial Outcomes & Findings for Study of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Steroid Therapy (NCT NCT01912404)
NCT ID: NCT01912404
Last Updated: 2016-11-04
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
28 days
Results posted on
2016-11-04
Participant Flow
This was a placebo-controlled, double-blind, multicenter Phase 2 study in patients with alcoholic hepatitis who were contraindicated to receive corticosteroid therapy. The study consisted of a 7-day screening phase, a 28-day treatment phase, and a follow-up of 5 months. Total study duration for a patient was about 6 months.
Eligible patients were randomized in a 2:1 ratio to IDN-6556 25 mg or placebo administered twice daily for 28 days. During the treatment phase, the patients were assessed for safety and efficacy. Following the treatment phase, the patients were asked to return for follow-up visits at 1, 2, and 5 months after completion of study drug treatment.
Participant milestones
| Measure |
IDN-6556
IDN-6556 capsules, 25 mg twice daily for 28 days
|
Placebo
Matching Placebo capsules twice daily for 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
IDN-6556
IDN-6556 capsules, 25 mg twice daily for 28 days
|
Placebo
Matching Placebo capsules twice daily for 28 days
|
|---|---|---|
|
Overall Study
Due to personal reasons
|
1
|
0
|
Baseline Characteristics
Study of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Steroid Therapy
Baseline characteristics by cohort
| Measure |
IDN-6556
n=3 Participants
IDN-6556 capsules, 25 mg twice daily for 28 days
|
Placebo
n=2 Participants
Matching Placebo capsules twice daily for 28 days
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 4.93 • n=5 Participants
|
31 years
STANDARD_DEVIATION 1.41 • n=7 Participants
|
41.6 years
STANDARD_DEVIATION 10.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: The study was prematurely stopped due to emerging data from another study showing \~10 to 12-fold higher exposures in patients with severe hepatic impairment compared to those with normal liver function. Since subjects with alcoholic hepatitis would likely have severe hepatic impairment, the study was stopped and survival data was not collected.
Outcome measures
Outcome data not reported
Adverse Events
IDN-6556
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDN-6556
n=3 participants at risk
IDN-6556 capsules, 25 mg twice daily for 28 days
|
Placebo
n=2 participants at risk
Matching Placebo capsules twice daily for 28 days
|
|---|---|---|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • 6 Months
|
50.0%
1/2 • Number of events 1 • 6 Months
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • 6 Months
|
50.0%
1/2 • Number of events 1 • 6 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • 6 Months
|
50.0%
1/2 • Number of events 1 • 6 Months
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3 • 6 Months
|
50.0%
1/2 • Number of events 1 • 6 Months
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/3 • 6 Months
|
50.0%
1/2 • Number of events 1 • 6 Months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • 6 Months
|
50.0%
1/2 • Number of events 1 • 6 Months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
33.3%
1/3 • Number of events 1 • 6 Months
|
100.0%
2/2 • Number of events 2 • 6 Months
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Number of events 1 • 6 Months
|
0.00%
0/2 • 6 Months
|
|
Infections and infestations
Periorbital cellulitis
|
33.3%
1/3 • Number of events 1 • 6 Months
|
0.00%
0/2 • 6 Months
|
|
Infections and infestations
Cellulitis
|
33.3%
1/3 • Number of events 1 • 6 Months
|
0.00%
0/2 • 6 Months
|
Other adverse events
| Measure |
IDN-6556
n=3 participants at risk
IDN-6556 capsules, 25 mg twice daily for 28 days
|
Placebo
n=2 participants at risk
Matching Placebo capsules twice daily for 28 days
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Number of events 2 • 6 Months
|
100.0%
2/2 • Number of events 2 • 6 Months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
66.7%
2/3 • Number of events 2 • 6 Months
|
100.0%
2/2 • Number of events 3 • 6 Months
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2 • 6 Months
|
50.0%
1/2 • Number of events 2 • 6 Months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
33.3%
1/3 • Number of events 1 • 6 Months
|
100.0%
2/2 • Number of events 2 • 6 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 2 • 6 Months
|
50.0%
1/2 • Number of events 4 • 6 Months
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Number of events 1 • 6 Months
|
50.0%
1/2 • Number of events 1 • 6 Months
|
|
Nervous system disorders
Hepatic encephalopathy
|
33.3%
1/3 • Number of events 1 • 6 Months
|
50.0%
1/2 • Number of events 1 • 6 Months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Number of events 1 • 6 Months
|
50.0%
1/2 • Number of events 1 • 6 Months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • 6 Months
|
100.0%
2/2 • Number of events 4 • 6 Months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • 6 Months
|
50.0%
1/2 • Number of events 3 • 6 Months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • 6 Months
|
50.0%
1/2 • Number of events 1 • 6 Months
|
|
Renal and urinary disorders
Renal failure acute
|
33.3%
1/3 • Number of events 1 • 6 Months
|
50.0%
1/2 • Number of events 2 • 6 Months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
33.3%
1/3 • Number of events 1 • 6 Months
|
50.0%
1/2 • Number of events 1 • 6 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60