Back to resultsIL-1 Signal Inhibition in Alcoholic Hepatitis (ISAIAH)
Primary Purpose
Alcoholic Hepatitis
Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Canakinumab 150mg/ml solution for injection
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholic Hepatitis focused on measuring Canakinumab, Alcoholic Hepatitis, Alcohol Use Disorder, Interleukin, Treatment, Ilaris, Liver disease
Eligibility Criteria
Inclusion Criteria:
- Male and female patients aged 18 years or older at screening
Clinical diagnosis of alcoholic hepatitis at screening:
- Serum bilirubin > 80μmol/L
- History of excess alcohol (> 80g/day male, > 60g/day female) to within 6 weeks before screening visit
- Less than 4 weeks since admission to hospital at baseline visit
- mDF* ≥ 32 and MELD ≤ 27 at baseline visit
- Informed consent
- Women of child-bearing potential have to use an effective contraception method (as specified in section 9.6).
Exclusion Criteria:
- Alcohol abstinence of >6 weeks prior to randomization/baseline visit
- Duration of clinically apparent jaundice > 3 months before baseline visit
Other causes of liver disease including:
- Evidence of chronic viral hepatitis (Hepatitis B or C)
- Biliary obstruction
- Hepatocellular carcinoma
- Evidence of current malignancy (except non-melanotic skin cancer)
- Previous entry into the study, or use of either prednisolone or any systemic steroids (equivalent to a dose of systemic prednisolone >20mg) within 6 weeks of screening.
- AST >500 U/L or ALT >300 U/L (not compatible with alcoholic hepatitis)
- Patients with a serum creatinine >220 μmol/L (2.5 mg / dL) or requiring renal support (see below)
- Patients dependent upon inotropic support (adrenaline or noradrenaline). Terlipressin is allowed
- Variceal haemorrhage on this admission
- Untreated sepsis (see below)
- Patients with known hypersensitivity or contraindications to Canakinumab
- Patients with cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction (within the last 6 weeks) or severe cardiac arrhythmias (not including atrial fibrillation)
- Pregnant or lactating women
- Patients treated with other IL-1 inhibitors and biologics or any other immunosuppressants within 3 months of study participation.
- Known infection with HIV at screening or randomization
- History or evidence of tuberculosis (TB) (active or latent) infection
- Active ongoing inflammatory diseases other than AAH that might confound the evaluation of the benefit of canakinumab therapy
- Underlying metabolic, hematologic, renal, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, including neutropenia (ANC <1.5) and leukopenia, which in the opinion of the investigator immune-compromises the subject and/or places the subject at unacceptable risk for participation in an immunomodulatory therapy.
- Significant medical problems or diseases, including but not limited to the following: uncontrolled hypertension (≥160/95 mmHg), congestive heart failure [New York Heart Association status of class III or IV], uncontrolled diabetes
- Vaccination with a live vaccine within 3 month before baseline
Sites / Locations
- University Hospitals Bristol NHS Foundation TrustRecruiting
- Glasgow Royal Infirmary, Greater Glasgow & ClydeRecruiting
- Queen Elizabeth University Hospital
- Leeds Teaching Hospitals NHS TrustRecruiting
- Aintree University HospitalRecruiting
- Royal Liverpool and Broadgreen University Hospitals NHS TrustRecruiting
- Imperial College Healthcare NHS Foundation TrustRecruiting
- Chelsea and Westminster Hospital NHS Foundation TrustRecruiting
- King's College Hospital NHS Foundation TrustRecruiting
- Royal Free London NHS Foundation TrustRecruiting
- St George's University Hospitals NHS Foundation TrustRecruiting
- The Newcastle Upon Tyne Hospitals NHS Foundation TrustRecruiting
- Nottingham University Hospitals NHS TrustRecruiting
- John Radcliffe Hospital, Oxford University NHS Foundation TrustRecruiting
- Plymouth Hospitals NHS TrustRecruiting
- University Hospital Southampton NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Canakinumab 150mg/ml solution for injection
Dextrose
Arm Description
150mg/ml solution for injection
Outcomes
Primary Outcome Measures
Histological improvement of alcoholic hepatitis on liver biopsy after 28 days of treatment compared to baseline.
Histological improvement is defined as a reduction in lobular inflammation (regardless of cell type).
Secondary Outcome Measures
Improvement of individual components of alcoholic hepatitis on liver histology from baseline to Day 28.
Improvement will be recorded as a binary Yes/No outcome. The outcome will be analysed as the percentage of patients, within each treatment group, with improvement on each individual component (polymorphonuclear cell infiltrate, ballooned hepatocytes and steatosis). Analysis will be based on three pairs of percentages which will represent the proportion of patients with improvement for each component.
Changes in the components of Alcoholic Hepatitis Histological Score (AHHS) from baseline to Day 28
Four histologic features are combined to create the AHHS score: Fibrosis stage (0-3), bilirubinostasis (0-2), polymorphonuclear infiltration (0-2), and megamitochondria (0-2) for a total of 9 points (Mild 0-3; Intermediate 4-5; Severe 6-9). AHHS score will be compared between active treatment and placebo treatment groups.
Changes in the components of Nonalcoholic fatty liver disease activity score (NAS) from baseline to Day 28
The NAS score combines steatosis grade, lobular inflammation, and liver cell injury (ballooning). Scoring: 0-2 Not steatohepatitis; 3-4 Indeterminate; ≥5, Steatohepatitis. NAS score will be compared between active treatment and placebo treatment groups.
Changes in hepatic venous pressure gradient (HVPG) between baseline and day 28
Changes in serum CK18-M30/M65 from baseline to Day 7, 14, 21, 28, 42 and 90
Change in serum bilirubin from baseline to Day 7, 14, 28, 21, 42 and 90
Change in MELD (Model For End-Stage Liver Disease) score at from baseline to Day 7, 14, 21, 28, 42 and 90
MELD score is based on the following formula: MELD Score = 10 * ((0.957 * ln(Creatinine)) + (0.378 * ln(Bilirubin)) + (1.12 * ln(INR))) + 6.43
Change in Glasgow Alcoholic Hepatitis Score (GAHS) from baseline to Day 7, 14, 21, 28, 42 and 90
Predicts mortality in patients with alcoholic hepatitis by laboratory results and age. GAHS score is calculated after Forrest et al., 2007 where a score of 1-3 is assigned based on age, WCC, Urea, PT ratio or INR and bilirubin.
Change in Maddrey's Discriminant Function (mDF) score from baseline to Day 7, 14, 21, 28, 42 and 90
mDF is calculated using the following formula: mDF = 4.6 x (Prothrombin time (PTPATIENT - PTCONTROL) + Serum Bilirubin (μmol/l) / 17.1 (PTCONTROL is defined as the mean value at each site; this mean value may be updated on a weekly or monthly basis), where a higher score is associated with poorer prognosis.
Lille score at Day 7
Lille score is calculated as Exp(-R)/[1+exp(-R)] where R = [3.19 - (0.101*age in years)] + (1.47*albumin at baseline in g/dL) + [0.28215* (bilirubin at baseline - bilirubin at Day 8 in mg/dL)] - [0.206 * (if creatinine>=1.3 mg/dL at baseline)] - [0.11115*bilirubin baseline in mg/dL] - (0.0096*Prothrombin Time in seconds at baseline).
The Lille Model predicts mortality rates within 6 months. Scores >0.45 predict a 6-month survival of 25%. Scores <0.45 predict a 6-month survival of 85%.
Resolution of Systemic Inflammatory Response Syndrome (SIRS) at Day 7, 14, 21, 28, 42 and 90 in patients with SIRS at baseline
Recommendations of the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference; where SIRS represents the presence of 2 or more criteria out of following:
Temperature < 36 ºC or > 38 ºC
Heart rate > 90 beats/minute
Respiratory rate > 20 breaths/minute or venous pCO2 <32 mmHg
Leukocyte count > 12,000/mm3 or < 4,000/mm3 or band forms > 10%
Incidence of SIRS at Day 7, 14, 21, 28, 42 and 90 in patients without SIRS at baseline
Recommendations of the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference; where SIRS represents the presence of 2 or more criteria out of following:
Temperature < 36 ºC or > 38 ºC
Heart rate > 90 beats/minute
Respiratory rate > 20 breaths/minute or venous pCO2 <32 mmHg
Leukocyte count > 12,000/mm3 or < 4,000/mm3 or band forms > 10%
Mortality rate at Day 90
Incidence of infection and sepsis over 90 days
Incidence of acute kidney injury over 90 days
Incidence of variceal haemorrhage, ascites or encephalopathy over 90 days
Safety and tolerability of canakinumab
The safety and tolerability of canakinumab will be assessed through the measurement of a number of participants with treatment-related adverse events.
Serum and plasma biomarkers of hepatic function and inflammation including cytokine profiles which may indicate the degree of response to IL-1b inhibition.
The aim is to monitor baseline levels of cytokines linked to inflammasome activation and their changes after active IMP treatment. The proposed method and cytokines is as follows:
MSD 7-plex kit will be used for the detection of the following cytokines: IL-18, IL-1β*, IL-1ra, IL-6, IL-8, IFNγ** and TNF-α
ELLA 1-plex will be used for the detection of the following cytokines: IL-18Bpa
Changes in CRP over time
Length of hospital stay
Full Information
NCT ID
NCT03775109
First Posted
December 10, 2018
Last Updated
February 9, 2023
Sponsor
Imperial College London
Collaborators
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03775109
Brief Title
IL-1 Signal Inhibition in Alcoholic Hepatitis
Acronym
ISAIAH
Official Title
IL-1 Signal Inhibition in Alcoholic Hepatitis (ISAIAH)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Alcoholic hepatitis (AH) is a florid presentation of alcoholic liver disease characterized by liver failure in the context of recent and heavy alcohol consumption. The condition carries a high fatality risk; patients with severe AH have a 30% mortality rate at 90 days after presentation.
Currently there is no effective treatment for severe alcoholic hepatitis. Based on our current understanding of the disease pathogenesis IL-1 (interleukin) is a key mediator of hepatic inflammation responsible for metabolic disturbances, fibrogenesis stellate cell activation and consequently portal hypertension.
Canakinumab is a licensed monoclonal antibody inhibitor of IL-1 and may consequently reverse the adverse effects of the cytokine in patients with this disorder. Therefore, the main objective of the ISAIAH trial is to explore the potential benefits of the IL-1β antibody, Canakinumab (solution for injection), in the treatment of alcoholic hepatitis.
ISAIAH is a multicentre, double blind, randomized (1:1), placebo controlled trial. The trial will follow patients up for 90 days and will be conducted in centres across the United Kingdom. Twenty-six patients will be recruited to each arm of the trial: total 52 patients.
Detailed Description
The main objective of the ISAIAH trial is to explore the potential benefits of the IL-1β antibody, Canakinumab (solution for injection), in the treatment of alcoholic hepatitis.
ISAIAH is a multicentre, double blind, randomized (1:1), placebo controlled trial. The trial will follow patients up for 90 days and will be conducted in centres across the United Kingdom. Twenty-six patients will be recruited to each arm of the trial: total 52 patients.
The trial will be conducted in patients with severe alcoholic hepatitis (mDF* ≥ 32 and MELD ≤27) with treatment initiated during an index hospital admission with the condition.
The primary endpoint of the trial is histological improvement of alcoholic hepatitis on liver biopsy after 28 days of treatment compared to baseline. Histological improvement is defined as a reduction in lobular inflammation (regardless of cell type).
Patients meeting the eligibility criteria will be randomized and treated. A single dose of 3 mg/kg Canakinumab or identical placebo will be administered intravenously at baseline (Day 1). Canakinumab will be made up by dilution in 100 ml 5% Dextrose by an unblinded research personnel at each site.
Patients with AST >2 x ULN on Day 28 will receive a second dose of 3 mg/kg study drug administered i.v. on Day 28. Patients who received placebo on baseline will receive placebo. Patients who received canakinumab on baseline will receive canakinumab.
Total follow up time for each patient is 90 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Hepatitis
Keywords
Canakinumab, Alcoholic Hepatitis, Alcohol Use Disorder, Interleukin, Treatment, Ilaris, Liver disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Canakinumab 150mg/ml solution for injection
Arm Type
Active Comparator
Arm Description
150mg/ml solution for injection
Arm Title
Dextrose
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Canakinumab 150mg/ml solution for injection
Intervention Description
Canakinumab 150mg/ml solution for injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
100ml 5% Dextrose
Primary Outcome Measure Information:
Title
Histological improvement of alcoholic hepatitis on liver biopsy after 28 days of treatment compared to baseline.
Description
Histological improvement is defined as a reduction in lobular inflammation (regardless of cell type).
Time Frame
Baseline and 28 days
Secondary Outcome Measure Information:
Title
Improvement of individual components of alcoholic hepatitis on liver histology from baseline to Day 28.
Description
Improvement will be recorded as a binary Yes/No outcome. The outcome will be analysed as the percentage of patients, within each treatment group, with improvement on each individual component (polymorphonuclear cell infiltrate, ballooned hepatocytes and steatosis). Analysis will be based on three pairs of percentages which will represent the proportion of patients with improvement for each component.
Time Frame
Baseline and 28 days
Title
Changes in the components of Alcoholic Hepatitis Histological Score (AHHS) from baseline to Day 28
Description
Four histologic features are combined to create the AHHS score: Fibrosis stage (0-3), bilirubinostasis (0-2), polymorphonuclear infiltration (0-2), and megamitochondria (0-2) for a total of 9 points (Mild 0-3; Intermediate 4-5; Severe 6-9). AHHS score will be compared between active treatment and placebo treatment groups.
Time Frame
Baseline and 28 days
Title
Changes in the components of Nonalcoholic fatty liver disease activity score (NAS) from baseline to Day 28
Description
The NAS score combines steatosis grade, lobular inflammation, and liver cell injury (ballooning). Scoring: 0-2 Not steatohepatitis; 3-4 Indeterminate; ≥5, Steatohepatitis. NAS score will be compared between active treatment and placebo treatment groups.
Time Frame
Baseline and 28 days
Title
Changes in hepatic venous pressure gradient (HVPG) between baseline and day 28
Time Frame
Baseline and 28 days
Title
Changes in serum CK18-M30/M65 from baseline to Day 7, 14, 21, 28, 42 and 90
Time Frame
Baseline and 7, 14, 21, 28, 42, 90 days
Title
Change in serum bilirubin from baseline to Day 7, 14, 28, 21, 42 and 90
Time Frame
Baseline and 7, 14, 21, 28, 42, 90 days
Title
Change in MELD (Model For End-Stage Liver Disease) score at from baseline to Day 7, 14, 21, 28, 42 and 90
Description
MELD score is based on the following formula: MELD Score = 10 * ((0.957 * ln(Creatinine)) + (0.378 * ln(Bilirubin)) + (1.12 * ln(INR))) + 6.43
Time Frame
Baseline and 7, 14, 21, 28, 42, 90 days
Title
Change in Glasgow Alcoholic Hepatitis Score (GAHS) from baseline to Day 7, 14, 21, 28, 42 and 90
Description
Predicts mortality in patients with alcoholic hepatitis by laboratory results and age. GAHS score is calculated after Forrest et al., 2007 where a score of 1-3 is assigned based on age, WCC, Urea, PT ratio or INR and bilirubin.
Time Frame
90 days
Title
Change in Maddrey's Discriminant Function (mDF) score from baseline to Day 7, 14, 21, 28, 42 and 90
Description
mDF is calculated using the following formula: mDF = 4.6 x (Prothrombin time (PTPATIENT - PTCONTROL) + Serum Bilirubin (μmol/l) / 17.1 (PTCONTROL is defined as the mean value at each site; this mean value may be updated on a weekly or monthly basis), where a higher score is associated with poorer prognosis.
Time Frame
Baseline and 7, 14, 21, 28, 42, 90 days
Title
Lille score at Day 7
Description
Lille score is calculated as Exp(-R)/[1+exp(-R)] where R = [3.19 - (0.101*age in years)] + (1.47*albumin at baseline in g/dL) + [0.28215* (bilirubin at baseline - bilirubin at Day 8 in mg/dL)] - [0.206 * (if creatinine>=1.3 mg/dL at baseline)] - [0.11115*bilirubin baseline in mg/dL] - (0.0096*Prothrombin Time in seconds at baseline).
The Lille Model predicts mortality rates within 6 months. Scores >0.45 predict a 6-month survival of 25%. Scores <0.45 predict a 6-month survival of 85%.
Time Frame
7 days
Title
Resolution of Systemic Inflammatory Response Syndrome (SIRS) at Day 7, 14, 21, 28, 42 and 90 in patients with SIRS at baseline
Description
Recommendations of the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference; where SIRS represents the presence of 2 or more criteria out of following:
Temperature < 36 ºC or > 38 ºC
Heart rate > 90 beats/minute
Respiratory rate > 20 breaths/minute or venous pCO2 <32 mmHg
Leukocyte count > 12,000/mm3 or < 4,000/mm3 or band forms > 10%
Time Frame
Baseline and 7, 14, 21, 28, 42, 90 days
Title
Incidence of SIRS at Day 7, 14, 21, 28, 42 and 90 in patients without SIRS at baseline
Description
Recommendations of the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference; where SIRS represents the presence of 2 or more criteria out of following:
Temperature < 36 ºC or > 38 ºC
Heart rate > 90 beats/minute
Respiratory rate > 20 breaths/minute or venous pCO2 <32 mmHg
Leukocyte count > 12,000/mm3 or < 4,000/mm3 or band forms > 10%
Time Frame
Baseline and 7, 14, 21, 28, 42, 90 days
Title
Mortality rate at Day 90
Time Frame
90 days
Title
Incidence of infection and sepsis over 90 days
Time Frame
90 days
Title
Incidence of acute kidney injury over 90 days
Time Frame
90 days
Title
Incidence of variceal haemorrhage, ascites or encephalopathy over 90 days
Time Frame
90 days
Title
Safety and tolerability of canakinumab
Description
The safety and tolerability of canakinumab will be assessed through the measurement of a number of participants with treatment-related adverse events.
Time Frame
90 days
Title
Serum and plasma biomarkers of hepatic function and inflammation including cytokine profiles which may indicate the degree of response to IL-1b inhibition.
Description
The aim is to monitor baseline levels of cytokines linked to inflammasome activation and their changes after active IMP treatment. The proposed method and cytokines is as follows:
MSD 7-plex kit will be used for the detection of the following cytokines: IL-18, IL-1β*, IL-1ra, IL-6, IL-8, IFNγ** and TNF-α
ELLA 1-plex will be used for the detection of the following cytokines: IL-18Bpa
Time Frame
90 days
Title
Changes in CRP over time
Time Frame
90 days
Title
Length of hospital stay
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients aged 18 years or older at screening
Clinical diagnosis of alcoholic hepatitis at screening:
Serum bilirubin > 80μmol/L
History of excess alcohol (> 80g/day male, > 60g/day female) to within 6 weeks before screening visit
Less than 4 weeks since admission to hospital at baseline visit
mDF* ≥ 32 and MELD ≤ 27 at baseline visit
Informed consent
Women of child-bearing potential have to use an effective contraception method (as specified in section 9.6).
Exclusion Criteria:
Alcohol abstinence of >6 weeks prior to randomization/baseline visit
Duration of clinically apparent jaundice > 3 months before baseline visit
Other causes of liver disease including:
Evidence of chronic viral hepatitis (Hepatitis B or C)
Biliary obstruction
Hepatocellular carcinoma
Evidence of current malignancy (except non-melanotic skin cancer)
Previous entry into the study, or use of either prednisolone or any systemic steroids (equivalent to a dose of systemic prednisolone >20mg) within 6 weeks of screening.
AST >500 U/L or ALT >300 U/L (not compatible with alcoholic hepatitis)
Patients with a serum creatinine >220 μmol/L (2.5 mg / dL) or requiring renal support (see below)
Patients dependent upon inotropic support (adrenaline or noradrenaline). Terlipressin is allowed
Variceal haemorrhage on this admission
Untreated sepsis (see below)
Patients with known hypersensitivity or contraindications to Canakinumab
Patients with cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction (within the last 6 weeks) or severe cardiac arrhythmias (not including atrial fibrillation)
Pregnant or lactating women
Patients treated with other IL-1 inhibitors and biologics or any other immunosuppressants within 3 months of study participation.
Known infection with HIV at screening or randomization
History or evidence of tuberculosis (TB) (active or latent) infection
Active ongoing inflammatory diseases other than AAH that might confound the evaluation of the benefit of canakinumab therapy
Underlying metabolic, hematologic, renal, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, including neutropenia (ANC <1.5) and leukopenia, which in the opinion of the investigator immune-compromises the subject and/or places the subject at unacceptable risk for participation in an immunomodulatory therapy.
Significant medical problems or diseases, including but not limited to the following: uncontrolled hypertension (≥160/95 mmHg), congestive heart failure [New York Heart Association status of class III or IV], uncontrolled diabetes
Vaccination with a live vaccine within 3 month before baseline
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Thursz, MBBS MD FRCP
Phone
02075940995
Email
isaiah@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Justyna Czyzewska-Khan
Phone
02075941687
Email
isaiah@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Thursz
Organizational Affiliation
Imperial College London
Official's Role
Study Director
Facility Information:
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne McCune
Facility Name
Glasgow Royal Infirmary, Greater Glasgow & Clyde
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewan Forrest
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
Country
United Kingdom
Individual Site Status
Terminated
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Parker
Facility Name
Aintree University Hospital
City
Liverpool
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyril SIEBERHAGEN
Facility Name
Royal Liverpool and Broadgreen University Hospitals NHS Trust
City
Liverpool
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Richardson
Facility Name
Imperial College Healthcare NHS Foundation Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Thursz
Phone
020 3312 5359
Facility Name
Chelsea and Westminster Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gavin Whitehouse
Facility Name
King's College Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vishal Patel
Facility Name
Royal Free London NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Patch
Facility Name
St George's University Hospitals NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arjuna Singanayagam
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
City
Newcastle Upon Tyne
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Masson
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Ryder
Facility Name
John Radcliffe Hospital, Oxford University NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Cobbold
Facility Name
Plymouth Hospitals NHS Trust
City
Plymouth
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashwin Dhanda
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Wright
12. IPD Sharing Statement
Plan to Share IPD
No
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IL-1 Signal Inhibition in Alcoholic Hepatitis
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