Health Condition 1: K701- Alcoholic hepatitis
Conditions
Interventions
Intervention1: Nor- Ursodeoxycholic Acid: Patient will be advised to take 3 Tablets of NorUDCA 500 mg orally once daily along with SOC for 6 months
Control Intervention1: Ursodeoxycholic Acid: Patient
Sponsors
Pulse Multispecialty Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1 Participants must be male or female adults between 18 and 65 years of age 2 Participants must have a documented history of heavy alcohol consumption defined as more than 80 g per day for males or 60 g per day for females sustained for at least six months with continued alcohol intake within two months prior to enrollment 3 Participants must demonstrate biochemical evidence consistent with moderate alcoholic hepatitis including AST greater than 50 IU per mL to less than 400 IU per mL AST or ALT greater than 1 point 5 MDF less than 32 Participants must have a Model for End-Stage Liver Disease MELD score in range of 15 to 29 both are inclusive to confirm disease severity 5 Patients with Child Pugh class B at screening 6 Participants must have alcoholic hepatitis confirmed either by liver histopathology if available or by a combination of clinical findings laboratory abnormalities and supportive radiological features consistent with the diagnosis 7 Participants must be hemodynamically stable at enrollment with no requirement for support 8 Participants must not be anticipated to require emergency liver transplantation within 30 days as assessed by the investigator 9 Participants must be willing to maintain complete alcohol abstinence throughout the study period 10 Participants must provide written informed consent prior to initiation of any study-related procedures 11 Women of childbearing potential must have a negative pregnancy test at screening and agree to use highly effective contraception during the study 12 Male with partners of childbearing potential must agree to use effective contraception during the study period as required by the protocol 13 Participants must be willing and able to comply with all study procedures including scheduled assessments hospitalization for the initial seven days 14 Participants must have the ability and willingness to comply with all follow-up visits assessments and study requirements for the entire duration of the study
Exclusion criteria
Exclusion criteria: 1 Abstinence from alcohol for more than 6 weeks prior to randomization 2 Duration of jaundice exceeding 3 months before screening 3 History or presence of hepatic encephalopathy at screening 4 Evidence of other concurrent liver diseases including but not limited to autoimmune hepatitis primary biliary cholangitis primary sclerosing cholangitis Wilson s disease or alpha-1 antitrypsin deficiency 5 Presence or suspicion of hepatocellular carcinoma HCC based on imaging or AFP levels 6 History of liver transplantation or currently listed for urgent liver transplantation 7 Severe acute pancreatitis occurred within the last 30 days 8 Clinically significant cardiac respiratory neurological or other systemic disease that may interfere with study participation or safety 9 Hypotension defined as blood pressure less than 90 by 60 mmHg after adequate fluid resuscitation 10 Uncontrolled systemic infection, including fever less than 38 degree Celsius with positive blood cultures despite being on appropriate antibiotics for greater than or equal to 3 days within 3 days prior to screening 11 Acute gastrointestinal bleeding requiring more than 2 units of blood transfusion within the previous 4 days 12 Prior treatment with corticosteroids for more than 3 days within 3 days before inclusion 13 History of malignancy excluding resolved non melanoma skin cancer within the last 5 years 14 Confirmed HIV infection 15 Acute or chronic kidney injury with serum creatinine greater than 3 mg per dL 16 Severe coagulopathy defined as INR less than 2.5 not attributable to vitamin K deficiency 17 Severe hyponatremia defined as serum sodium less than 125 mmol per L 18 Positive serology for acute viral hepatitis including HAV IgM HBc IgM positive HBsAg with high viral load or HCV with high viral load at screening 19 Use of hepatotoxic medications eg high dose acetaminophen anti tuberculosis drugs within 30 days prior to screening 20 Use of any investigational drug or participation in another clinical trial within 30 days prior to screening 21 Severe psychiatric illness including uncontrolled psychosis or severe depression with suicidal ideation that may impair compliance 22 Inability or unwillingness to comply with study procedures follow-up visits or medication adherence 23 Known hypersensitivity to pentoxifylline methylxanthines Ursodeoxycholic acid UDCA nor UDCA or any study medication 24 Pregnant or lactating women or women of childbearing potential unwilling to use effective contraception during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 All cause mortality assessed as time to event 2 Change in Model for End Stage Liver Disease MELD score Timepoint: 1 upto 180 days from baseline 2 baseline to 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Change in liver function parameters including AST ALT ALP GGT total bilirubin albumin and PT or INR 2 Change in liver stiffness and Controlled Attenuation Parameter CAP score as measured by FibroScan 3 Change in disease severity scores specifically MELD and Maddrey s Discriminant Function MDF 4 Safety and tolerability of nor UDCA 1500 mg assessed by incidence severity and type of adverse events laboratory parameters vital signs and ECG findings 5 Changes in the Child Pugh score 6 Use of rescue medication prednisolone or methylprednisolone including proportion of participants requiring rescue time to initiation dose and duration compared between treatment arms 7 Quality of life assessed by change from baseline in SF 36 scores at prespecified study visits 8 Safety related events Adverse events Serious Adverse Events Timepoint: 1 from baseline to Day 30 Day 60 Day 90 and Day 180 2 from baseline to Day 90 and Day 180 3 from baseline to Day 90 and Day 180 4 from baseline up to Day 90 5 from baseline to day 90 and day 180 | — |
Countries
India
Contacts
Public ContactDr Seth Vishal Kumar Ratnakar
Pulse Multispecialty Hospital
Outcome results
None listed