Trial Outcomes & Findings for A Study of IDN-6556 in Cirrhotic Subjects With Portal Hypertension (NCT NCT02230683)
NCT ID: NCT02230683
Last Updated: 2016-12-21
Results Overview
Mean change of HVPG \[mmHg\] from Baseline to Day 28/EOT (end of treatment) for IDN-6556
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Baseline to Day 28/EOT (end of treatment)
Results posted on
2016-12-21
Participant Flow
Participant milestones
| Measure |
IDN-6556
IDN-6556 25 mg Dosed twice daily
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
IDN-6556
IDN-6556 25 mg Dosed twice daily
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Study of IDN-6556 in Cirrhotic Subjects With Portal Hypertension
Baseline characteristics by cohort
| Measure |
IDN-6556
n=23 Participants
IDN-6556 25 mg Dosed twice daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Gender
Female
|
7 Participants
n=5 Participants
|
|
Gender
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28/EOT (end of treatment)Population: 23 subjects were enrolled, of whom 22 were evaluable for the HVPG endpoint. 1 subject discontinued at day 1.
Mean change of HVPG \[mmHg\] from Baseline to Day 28/EOT (end of treatment) for IDN-6556
Outcome measures
| Measure |
IDN-6556 - Overall Population
n=22 Participants
Overall evaluable population treated with IDN-6556 25 mg twice daily with HVPG measurement at Baseline and Day 28
|
IDN-6556 - Subgroup With HVPG < 12 mmHg
n=10 Participants
Subgroup for patients with HVPG \< 12 mmHg that have been treated with IDN-6556 25 mg twice daily
|
IDN-6556 - Subgroup HVPG ≥ 12 mmHg
n=12 Participants
Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
|
|---|---|---|---|
|
Hepatic Venous Pressure Gradient (HVPG)
Baseline
|
15.2 mmHg
Standard Deviation 7.68
|
8.05 mmHg
Standard Deviation 1.88
|
20.62 mmHg
Standard Deviation 5.59
|
|
Hepatic Venous Pressure Gradient (HVPG)
Day 28/EOT
|
14.1 mmHg
Standard Deviation 6.40
|
10.0 mmHg
Standard Deviation 3.86
|
17.6 mmHg
Standard Deviation 6.10
|
|
Hepatic Venous Pressure Gradient (HVPG)
Change From Baseline
|
-1.14 mmHg
Standard Deviation 4.57
|
1.90 mmHg
Standard Deviation 3.15
|
-3.67 mmHg
Standard Deviation 4.05
|
PRIMARY outcome
Timeframe: Change from Baseline to Day 28/EOTAbsolute Mean Change of caspase-cleaved cytokeratin serum levels (cCK18/M30); the statistical analysis is based on the mean change in log-transformed cCK18/M30 from Baseline to Day 28/EOT (end of treatment) for IDN-6556
Outcome measures
| Measure |
IDN-6556 - Overall Population
n=23 Participants
Overall evaluable population treated with IDN-6556 25 mg twice daily with HVPG measurement at Baseline and Day 28
|
IDN-6556 - Subgroup With HVPG < 12 mmHg
n=10 Participants
Subgroup for patients with HVPG \< 12 mmHg that have been treated with IDN-6556 25 mg twice daily
|
IDN-6556 - Subgroup HVPG ≥ 12 mmHg
n=13 Participants
Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
|
|---|---|---|---|
|
cCK18/M30
|
-47.1 U/L
Standard Deviation 122.23
|
-74.3 U/L
Standard Deviation 99.02
|
-26.2 U/L
Standard Deviation 137.64
|
PRIMARY outcome
Timeframe: Baseline to Day 28/EOT (end of treatment)Median change of caspase-cleaved cytokeratin serum levels (cCK18/M30) from Baseline to Day 28/EOT (end of treatment) for IDN-6556
Outcome measures
| Measure |
IDN-6556 - Overall Population
n=23 Participants
Overall evaluable population treated with IDN-6556 25 mg twice daily with HVPG measurement at Baseline and Day 28
|
IDN-6556 - Subgroup With HVPG < 12 mmHg
n=10 Participants
Subgroup for patients with HVPG \< 12 mmHg that have been treated with IDN-6556 25 mg twice daily
|
IDN-6556 - Subgroup HVPG ≥ 12 mmHg
n=13 Participants
Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
|
|---|---|---|---|
|
Change in cCK18/M30
Baseline
|
191.0 U/L
Interval 78.0 to 994.0
|
189.0 U/L
Interval 126.0 to 442.0
|
221.0 U/L
Interval 78.0 to 994.0
|
|
Change in cCK18/M30
Day 28/EOT
|
143.0 U/L
Interval 48.0 to 548.0
|
124.5 U/L
Interval 48.0 to 291.0
|
186.0 U/L
Interval 94.0 to 548.0
|
|
Change in cCK18/M30
Change From Baseline at Day 28
|
-21.0 U/L
Interval -446.0 to 119.0
|
-52.5 U/L
Interval -323.0 to 45.0
|
12.0 U/L
Interval -446.0 to 119.0
|
SECONDARY outcome
Timeframe: Baseline to 28 days/EOTMedian change of ALT from Baseline to Day 28/EOT (end of treatment) for IDN-6556
Outcome measures
| Measure |
IDN-6556 - Overall Population
n=23 Participants
Overall evaluable population treated with IDN-6556 25 mg twice daily with HVPG measurement at Baseline and Day 28
|
IDN-6556 - Subgroup With HVPG < 12 mmHg
Subgroup for patients with HVPG \< 12 mmHg that have been treated with IDN-6556 25 mg twice daily
|
IDN-6556 - Subgroup HVPG ≥ 12 mmHg
Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
|
|---|---|---|---|
|
Change in Alanine Aminotransferase (ALT)
Baseline
|
25.0 U/L
Interval 10.0 to 99.0
|
—
|
—
|
|
Change in Alanine Aminotransferase (ALT)
Day 28/EOT
|
23.0 U/L
Interval 9.0 to 124.0
|
—
|
—
|
|
Change in Alanine Aminotransferase (ALT)
Change from Baseline at Day 28
|
-4.0 U/L
Interval -61.0 to 43.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 28 days/EOTMedian change of AST from Baseline to Day 28/EOT (end of treatment) for IDN-6556
Outcome measures
| Measure |
IDN-6556 - Overall Population
n=23 Participants
Overall evaluable population treated with IDN-6556 25 mg twice daily with HVPG measurement at Baseline and Day 28
|
IDN-6556 - Subgroup With HVPG < 12 mmHg
Subgroup for patients with HVPG \< 12 mmHg that have been treated with IDN-6556 25 mg twice daily
|
IDN-6556 - Subgroup HVPG ≥ 12 mmHg
Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
|
|---|---|---|---|
|
Change in Aspartate Aminotransferase (AST)
Baseline
|
35.0 U/L
Interval 16.0 to 83.0
|
—
|
—
|
|
Change in Aspartate Aminotransferase (AST)
Day 28/EOT
|
27.0 U/L
Interval 13.0 to 139.0
|
—
|
—
|
|
Change in Aspartate Aminotransferase (AST)
Change from Baseline at Day 28
|
-4.0 U/L
Interval -29.0 to 68.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 28 days/EOTMedian change of concentration of Caspase 3/7 Relative Light Units from Baseline to Day 28/EOT (end of treatment) for IDN-6556
Outcome measures
| Measure |
IDN-6556 - Overall Population
n=23 Participants
Overall evaluable population treated with IDN-6556 25 mg twice daily with HVPG measurement at Baseline and Day 28
|
IDN-6556 - Subgroup With HVPG < 12 mmHg
Subgroup for patients with HVPG \< 12 mmHg that have been treated with IDN-6556 25 mg twice daily
|
IDN-6556 - Subgroup HVPG ≥ 12 mmHg
Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
|
|---|---|---|---|
|
Concentration of Caspase 3/7 RLU
Baseline
|
1997 RLU
Interval 750.0 to 37428.0
|
—
|
—
|
|
Concentration of Caspase 3/7 RLU
Day 28/EOT
|
1518 RLU
Interval 276.0 to 3665.0
|
—
|
—
|
|
Concentration of Caspase 3/7 RLU
Change from Baseline at Day 28
|
-772 RLU
Interval -34734.0 to 1107.0
|
—
|
—
|
Adverse Events
IDN-6556
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDN-6556
n=23 participants at risk
IDN-6556 25 mg Dosed twice daily
|
|---|---|
|
General disorders
Systematic inflammatory response syndrome
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
Other adverse events
| Measure |
IDN-6556
n=23 participants at risk
IDN-6556 25 mg Dosed twice daily
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.3%
1/23 • Number of events 2 • Adverse Events were collected for a period of 8 months.
|
|
Cardiac disorders
Ventricular extrasystoles
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Ear and labyrinth disorders
Ear congestion
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Gastrointestinal disorders
Abdominal disorders
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Gastrointestinal disorders
Constipation
|
8.7%
2/23 • Number of events 2 • Adverse Events were collected for a period of 8 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
2/23 • Number of events 3 • Adverse Events were collected for a period of 8 months.
|
|
Gastrointestinal disorders
Dry mouth
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Gastrointestinal disorders
Mouth ulceration
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23 • Number of events 2 • Adverse Events were collected for a period of 8 months.
|
|
Gastrointestinal disorders
Oral pain
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
General disorders
Fatigue
|
21.7%
5/23 • Number of events 5 • Adverse Events were collected for a period of 8 months.
|
|
General disorders
Local swelling
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
General disorders
Oedema peripheral
|
13.0%
3/23 • Number of events 4 • Adverse Events were collected for a period of 8 months.
|
|
General disorders
Pain
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
General disorders
Pyrexia
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
General disorders
Soft tissue inflammation
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
General disorders
Systemic inflammatory response syndrome
|
4.3%
1/23 • Number of events 2 • Adverse Events were collected for a period of 8 months.
|
|
Immune system disorders
Hypersensitivity
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Immune system disorders
Seasonal allergy
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Infections and infestations
Conjunctivitis
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Infections and infestations
Hordeolum
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Infections and infestations
Localised infection
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Injury, poisoning and procedural complications
Scratch
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.7%
2/23 • Number of events 2 • Adverse Events were collected for a period of 8 months.
|
|
Musculoskeletal and connective tissue disorders
Connective tissue disorder
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Nervous system disorders
Headache
|
13.0%
3/23 • Number of events 3 • Adverse Events were collected for a period of 8 months.
|
|
Nervous system disorders
Somnolence
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Psychiatric disorders
Anxiety
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Psychiatric disorders
Confusional state
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Psychiatric disorders
Depression
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Renal and urinary disorders
Pollakiuria
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
|
Eye disorders
Eye discharge
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected for a period of 8 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60