Trial Outcomes & Findings for A Study of IDN-6556 in Subjects With Liver Cirrhosis (NCT NCT02230670)
NCT ID: NCT02230670
Last Updated: 2017-07-05
Results Overview
Baseline, Month 3, and change between for cCK18/M30
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
3 months
Results posted on
2017-07-05
Participant Flow
A total of 140 subjects from 26 US sites were screened, of whom 87 subjects were randomized. One subject randomized to placebo withdrew from the study before taking study drug. Disposition data is provided for the initial 3-month randomized, placebo-controlled phase on which the primary efficacy and safety analyses were based
Participant milestones
| Measure |
IDN-6556
25 mg BID of IDN-6556
IDN-6556: 25 mg BID
|
Placebo
Placebo BID
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
42
|
|
Overall Study
COMPLETED
|
40
|
34
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
Reasons for withdrawal
| Measure |
IDN-6556
25 mg BID of IDN-6556
IDN-6556: 25 mg BID
|
Placebo
Placebo BID
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Progression to Child-Pugh C
|
1
|
2
|
Baseline Characteristics
A Study of IDN-6556 in Subjects With Liver Cirrhosis
Baseline characteristics by cohort
| Measure |
IDN-6556
n=44 Participants
25 mg BID of IDN-6556
IDN-6556: 25 mg BID
|
Placebo
n=42 Participants
Placebo BID
Placebo
|
Total
n=86 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
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: FAS
Baseline, Month 3, and change between for cCK18/M30
Outcome measures
| Measure |
IDN-6556
n=44 Participants
25 mg BID of IDN-6556
IDN-6556: 25 mg BID
|
Placebo
n=42 Participants
Placebo BID
Placebo
|
|---|---|---|
|
Change From Baseline at Month 3 in cCK18/M30
Baseline
|
293.5 U/L
Interval 66.0 to 1857.0
|
257.5 U/L
Interval 104.0 to 6994.0
|
|
Change From Baseline at Month 3 in cCK18/M30
Month 3
|
288.5 U/L
Interval 39.0 to 1583.0
|
285.0 U/L
Interval 115.0 to 19710.0
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Full analysis set
Data was log-transformed for analysis purposes
Outcome measures
| Measure |
IDN-6556
n=44 Participants
25 mg BID of IDN-6556
IDN-6556: 25 mg BID
|
Placebo
n=42 Participants
Placebo BID
Placebo
|
|---|---|---|
|
Change From Baseline at Month 3 in cCK18/M30
Percent (%) Relative Change
|
-4.6 U/L
Standard Error 5.9
|
9.3 U/L
Standard Error 5.9
|
|
Change From Baseline at Month 3 in cCK18/M30
Log-transformed Values
|
-0.049 U/L
Standard Error 0.057
|
0.090 U/L
Standard Error 0.058
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: FAS
The Model for End-Stage Liver Disease (MELD) is a scoring system for assessing the severity of chronic liver disease and uses the subject's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. MELD is calculated according to the following formula: MELD = 3.78×ln\[serum bilirubin (mg/dL)\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43 MELD scores are reported as whole numbers, so the result of the equation above is rounded. Notes: If the patient has been dialyzed twice within the last 7 days, then the value for serum creatinine used should be 4.0. Any value less than one is given a value of 1 (i.e. if bilirubin is 0.8, a value of 1.0 is used) to prevent the occurrence of scores below 0 (the natural logarithm of 1 is 0, and any value below 1 would yield a negative result). The higher the MELD score the more severe the disease state.
Outcome measures
| Measure |
IDN-6556
n=44 Participants
25 mg BID of IDN-6556
IDN-6556: 25 mg BID
|
Placebo
n=42 Participants
Placebo BID
Placebo
|
|---|---|---|
|
Change From Baseline to Month 3 in MELD Score
|
-0.10 units on a scale
Standard Error 0.234
|
0.15 units on a scale
Standard Error 0.239
|
Adverse Events
IDN-6556 (Baseline-Month 3)
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo (Baseline-Month 3)
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDN-6556 (Baseline-Month 3)
n=44 participants at risk
25 mg BID of IDN-6556 (Baseline-Month 3).
|
Placebo (Baseline-Month 3)
n=42 participants at risk
Placebo BID (Baseline-Month 3)
|
|---|---|---|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/44 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
2.4%
1/42 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
0.00%
0/42 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
0.00%
0/42 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
2.3%
1/44 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
0.00%
0/42 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
2.3%
1/44 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
0.00%
0/42 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Infections and infestations
Peritontis bacterial
|
0.00%
0/44 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
2.4%
1/42 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Infections and infestations
Urosepsis
|
2.3%
1/44 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
0.00%
0/42 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Injury, poisoning and procedural complications
Accidential overdose
|
0.00%
0/44 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
2.4%
1/42 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.3%
1/44 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
0.00%
0/42 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Injury, poisoning and procedural complications
Stoma site heamorrhage
|
2.3%
1/44 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
0.00%
0/42 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
2.3%
1/44 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
0.00%
0/42 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
0.00%
0/42 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Nervous system disorders
Convulsions
|
2.3%
1/44 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
0.00%
0/42 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Nervous system disorders
Hepatic encephalopathy
|
2.3%
1/44 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
2.4%
1/42 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Nervous system disorders
intraventricular haemorrhage
|
0.00%
0/44 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
2.4%
1/42 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/44 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
2.4%
1/42 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrage
|
2.3%
1/44 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
0.00%
0/42 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
1/44 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
0.00%
0/42 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
Other adverse events
| Measure |
IDN-6556 (Baseline-Month 3)
n=44 participants at risk
25 mg BID of IDN-6556 (Baseline-Month 3).
|
Placebo (Baseline-Month 3)
n=42 participants at risk
Placebo BID (Baseline-Month 3)
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
6.8%
3/44 • Number of events 3 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
7.1%
3/42 • Number of events 3 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
General disorders
arthralgia
|
6.8%
3/44 • Number of events 3 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
0.00%
0/42 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Gastrointestinal disorders
ascites
|
2.3%
1/44 • Number of events 2 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
7.1%
3/42 • Number of events 3 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Metabolism and nutrition disorders
fatigue
|
9.1%
4/44 • Number of events 4 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
14.3%
6/42 • Number of events 7 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Nervous system disorders
headache
|
15.9%
7/44 • Number of events 8 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
7.1%
3/42 • Number of events 4 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Nervous system disorders
hepatic encephalopathy
|
11.4%
5/44 • Number of events 7 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
4.8%
2/42 • Number of events 3 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
0.00%
0/44 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
7.1%
3/42 • Number of events 3 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Gastrointestinal disorders
nausea
|
15.9%
7/44 • Number of events 8 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
9.5%
4/42 • Number of events 5 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Blood and lymphatic system disorders
oedema peripheral
|
2.3%
1/44 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
9.5%
4/42 • Number of events 4 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Infections and infestations
urinary tract infection
|
6.8%
3/44 • Number of events 3 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
2.4%
1/42 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
|
Gastrointestinal disorders
vomiting
|
11.4%
5/44 • Number of events 7 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
2.4%
1/42 • Number of events 1 • Adverse events were collected in a blinded fashion from baseline to Month 3. Double-blind adverse events are presented here
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60