Trial Outcomes & Findings for Safety and Efficacy of the ELAD System (ELAD) to Treat Acute Liver Failure (ALF) (NCT NCT01875874)
NCT ID: NCT01875874
Last Updated: 2019-02-12
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Study Day 1 through Study Day 28
Results posted on
2019-02-12
Participant Flow
Participant milestones
| Measure |
ELAD System (ELAD) Treatment Plus Standard of Care Treatment
Continuous treatment with the ELAD System (ELAD) for a minimum of 3 days to a maximum of 10 days in addition to a standard of care for subjects with acute liver failure.
ELAD: Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total).
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|---|---|
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Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
ELAD System (ELAD) Treatment Plus Standard of Care Treatment
Continuous treatment with the ELAD System (ELAD) for a minimum of 3 days to a maximum of 10 days in addition to a standard of care for subjects with acute liver failure.
ELAD: Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total).
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|---|---|
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Overall Study
Death
|
3
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Baseline Characteristics
Safety and Efficacy of the ELAD System (ELAD) to Treat Acute Liver Failure (ALF)
Baseline characteristics by cohort
| Measure |
ELAD Treatment Plus Standard of Care Treatment
n=8 Participants
Continuous ELAD treatment for a minimum of 3 days to a maximum of 10 days in addition to a standard of care for subjects with acute liver failure.
ELAD: Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total).
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 19.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 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
|
|
Region of Enrollment
United States
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8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Day 1 through Study Day 28Outcome measures
| Measure |
ELAD Treatment Plus Standard of Care Treatment
n=8 Participants
Continuous ELAD treatment for a minimum of 3 days to a maximum of 10 days in addition to a standard of care for subjects with acute liver failure.
ELAD: Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total).
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|---|---|
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Overall Survival (OS) of ALF Subjects
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5 Participants
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SECONDARY outcome
Timeframe: Study Day 1 through Study Day 28Outcome measures
| Measure |
ELAD Treatment Plus Standard of Care Treatment
n=8 Participants
Continuous ELAD treatment for a minimum of 3 days to a maximum of 10 days in addition to a standard of care for subjects with acute liver failure.
ELAD: Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total).
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|---|---|
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Number of Subjects Who Survived at the End of Study Day 28 or Who Received Orthotopic Liver Transplantation on or Before That Study Day.
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5 Participants
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Adverse Events
ELAD Treatment Plus Standard of Care Treatment
Serious events: 6 serious events
Other events: 7 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
ELAD Treatment Plus Standard of Care Treatment
n=7 participants at risk
Continuous ELAD treatment for a minimum of 3 days to a maximum of 10 days in addition to a standard of care for subjects with acute liver failure.
ELAD: Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total).
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|---|---|
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Blood and lymphatic system disorders
Anaemia
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
General disorders
Multi-organ failure
|
42.9%
3/7 • Number of events 3
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Immune system disorders
Liver transplant rejection
|
14.3%
1/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Metabolism and nutrition disorders
Hyperammonaemia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Metabolism and nutrition disorders
Hyperglycaemia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Nervous system disorders
Cerebral haemorrhage
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Nervous system disorders
Hepatic encephalopathy
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
Other adverse events
| Measure |
ELAD Treatment Plus Standard of Care Treatment
n=7 participants at risk
Continuous ELAD treatment for a minimum of 3 days to a maximum of 10 days in addition to a standard of care for subjects with acute liver failure.
ELAD: Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total).
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|---|---|
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Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Nervous system disorders
Brain injury
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Nervous system disorders
Intracranial pressure increased
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Psychiatric disorders
Agitation
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Psychiatric disorders
Anxiety
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Psychiatric disorders
Delirium
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Psychiatric disorders
Insomnia
|
42.9%
3/7 • Number of events 3
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Respiratory, thoracic and mediastinal disorders
Atelectasis
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
57.1%
4/7 • Number of events 4
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Skin and subcutaneous tissue disorders
Ecchymosis
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Vascular disorders
Deep vein thrombosis
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Vascular disorders
Hypertension
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Vascular disorders
Hypotension
|
57.1%
4/7 • Number of events 5
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Blood and lymphatic system disorders
Anaemia
|
71.4%
5/7 • Number of events 6
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Blood and lymphatic system disorders
Anaemia macrocytic
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Blood and lymphatic system disorders
Hypofibrinogenaemia
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Blood and lymphatic system disorders
Leukocytosis
|
42.9%
3/7 • Number of events 3
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Blood and lymphatic system disorders
Leukopenia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
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Cardiac disorders
Arrhythmia supraventricular
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Cardiac disorders
Cyanosis
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Cardiac disorders
Pericardial effusion
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Cardiac disorders
Sinus bradycardia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Cardiac disorders
Tachycardia
|
57.1%
4/7 • Number of events 4
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Cardiac disorders
Ventricular arrhythmia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Eye disorders
Dry eye
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Gastrointestinal disorders
Ascites
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
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Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Gastrointestinal disorders
Ileus
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Gastrointestinal disorders
Melaena
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Gastrointestinal disorders
Oral mucosa erosion
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Gastrointestinal disorders
Pancreatitis
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
General disorders
Application site necrosis
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
General disorders
Catheter site haematoma
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
General disorders
Catheter site haemorrhage
|
42.9%
3/7 • Number of events 3
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
General disorders
Chest pain
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
General disorders
Chills
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
General disorders
Gait disturbance
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
General disorders
Generalized oedema
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
General disorders
Hypothermia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
General disorders
Oedema peripheral
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
General disorders
Peripheral swelling
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
General disorders
Pyrexia
|
57.1%
4/7 • Number of events 5
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Hepatobiliary disorders
Biliary fistula
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Hepatobiliary disorders
Cholangitis
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Infections and infestations
Clostridium difficile colitis
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Infections and infestations
Pneumonia
|
28.6%
2/7 • Number of events 3
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Injury, poisoning and procedural complications
Complications of transplant surgery
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Injury, poisoning and procedural complications
Hepatic haematoma
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Injury, poisoning and procedural complications
Laceration
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Injury, poisoning and procedural complications
Wound
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Investigations
Alpha 1 foetoprotein increased
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Investigations
Amylase increased
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Investigations
Body temperature increased
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Investigations
Candida test positive
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Investigations
Electrocardiogram QT prolonged
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Investigations
Electrocardiogram ST segment elevation
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Investigations
Electrocardiogram T wave inversion
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Investigations
Liver function test abnormal
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Investigations
Occult blood positive
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Investigations
Oxygen saturation decreased
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Metabolism and nutrition disorders
Fluid overload
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
14.3%
1/7 • Number of events 1
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
28.6%
2/7 • Number of events 2
One subject was not treated with ELAD due to substantial improvement of their condition prior to treatment initiation. Therefore, only 7 subjects were exposed to ELAD treatment and at risk for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place