CovidResearchTrials by Shray Alag


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HP:0012115: HepatitisHPO

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug167 Anakinra and Zinc Wiki 1.00
drug1898 Prednisone Wiki 0.45
drug1860 Placebos Wiki 0.24

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D006505 Hepatitis NIH 1.00
D006506 Hepatitis A NIH 1.00
D006519 Hepatitis, Alcoholic NIH 1.00

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 A Multicenter, Randomized, Double Blinded, Placebo-controlled Clinical Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis by the AlcHepNet Consortium

This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases. The primary objective of the study is to determine the clinical efficacy and safety of Anakinra (plus zinc) compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH. Key secondary objectives broadly are as follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment response; and (b) to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH.

NCT04072822 Alcoholic Hepatitis Drug: Anakinra and Zinc Drug: Prednisone Drug: Placebos
MeSH:Hepatitis A Hepatitis Hepatitis, Alcoholic
HPO:Hepatitis

Primary Outcomes

Description: The primary analysis will be comparisons of 90-day mortality of Prednisone and Anakinra plus zinc vs Prednisone.

Measure: Survival at 90 days

Time: 90 days

Secondary Outcomes

Description: Score will be calculated using the following website: https://www.mdcalc.com/lille-model-alcoholic-hepatitis (exp(-R))/(1 + exp(-R)) where the variables are as follows: R = 3.19 - 0.101*(age, years) + 0.147*(albumin day 0, g/L) + 0.0165* (evolution in bilirubin level, µmol/L) - 0.206*(renal insufficiency) - 0.0065*(bilirubin day 0, µmol/L) - 0.0096*(PT, sec) Renal insufficiency = 1 (if Cr >1.3 mg/dL (115 µmol/L)) or 0 (if ≤1.3 mg/dL (115 µmol/L))

Measure: Changes is Lille score

Time: 7, 30, and 90 days

Description: The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.

Measure: Changes in MELD score

Time: 7, 30, and 90 days

Description: Increase in creatinine of 50% above baseline over a period of 7 days Increase in creatinine of 0.3 mg/dl within a period of 48 hrs Onset of renal failure requiring dialysis

Measure: Progression of the development of AKI (acute kidney injury)

Time: 7, 30, and 90 days

Description: Defined as failure ≥2 organs

Measure: Progression of the development of multi-organ failure

Time: 7, 30, and 90 days

Description: Defined as two or more abnormalities in temperature, increased heart rate, respiration, or white blood cell count with increase in SOFA score ≥2 points

Measure: Progression of the development of SIRS (Systemic Inflammatory Response Syndrome)

Time: 7, 30, and 90 days

Description: Recording the change of hospital word from regular floor to ICU floor as a marker for worsening illness and care escalation

Measure: Number of Transfers to ICU

Time: 7, 30, and 90 days

Description: New onset of ascites if not present on admission to study New onset of variceal hemorrhage New onset of hepatic encephalopathy (HE).

Measure: Rate of changes in liver function

Time: 7, 30, and 90 days

Description: The SOFA score will be modified and re-evaluated without platelet counts given that these are usually low in AH.

Measure: Measure of changes in sequential organ failure Assessment (SOFA) scores and proportions requiring hemodynamic support for MAP < 65 mm Hg and lactate > 2 mmol/l, renal replacement therapy or mechanical ventilation.

Time: 180 days

Description: Pneumonia defined as new infiltrate by CXR or Chest CT scan not explained by "fluid overload" Positive blood cultures for bacteria or fungus, not suspected as contaminant Positive urine fungal culture > 50,000 colonies/ml Positive urine bacterial culture > 100,000 colonies/ml (mixed flora is excluded) Soft tissue or bone infections including cellulitis or abscess documented by exam or scan CNS infection defined as positive culture of CSF or > 5 WBC/ml Ascitic fluid white cell count >500/ml or neutrophils>250/ml. with or without positive bacterial or fungal cultures

Measure: Measuring the types of infections

Time: 180 days

Description: Life-threatening organ dysfunction caused by a dysregulated host response to infection An increase in SOFA score of 2 points of more Note: most participants with severe AH have 4 points based on bilirubin only

Measure: Rate of the progression of sepsis

Time: 180 days

Description: Defined by a creatinine > 2 mg/dl

Measure: Rate of the progression of renal dysfunction

Time: 180 days

Description: Proportion of participants requiring transfer to ICU for care, intubation for airway control, need for ventilator support or RRT.

Measure: Need for care escalation

Time: 180 days

Measure: Indicators of gut permeability

Time: 180 days

Measure: Survival

Time: 30 days and 180 days


HPO Nodes