CTRI/2022/07/043725
Active, Not Recruiting
Phase 3
Clinical Study to evaluate the safety and efficacy of Livercure tablets on patients with Liver Cirrhosis
Jammi Pharmaceuticals Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: K745- Biliary cirrhosis, unspecifiedHealth Condition 2: K745- Biliary cirrhosis, unspecified
- Sponsor
- Jammi Pharmaceuticals Pvt Ltd
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Patients aged between 18 to 70 years with a confirmed diagnosis of liver cirrhosis (diagnosed by clinical, biochemical, sonographic or histological evidence of cirrhosis and portal hypertension).
- •2 Evidence of decompensated liver disease at screening (e.g., Child class B or C, Child\-Pugh scores of \=7\).
- •3 MELD scores of at least 10 (UNOS Meld calculator).
- •4 AFP Level \< 400ng/ml.
- •5 Signed informed consent.
- •6 Excessive consumption of alcohol ( \>30 gm of absolute alcohol/day) use in the last 3 months before screening can be included
- •7 Positive HBsAg or antibodies to HCV
Exclusion Criteria
- •1 Patients likely to undergo liver transplantation during the duration of the study.
- •2 Presence of advanced hepatic encephalopathy Grades 3 and 4 at the time of screening\- Annexure V.
- •3 Evidences of autoimmune liver disease\- ANA or Anti\-LKM positivity.
- •4 Platelet count \< 30,000/mm3\.
- •5 Serum Sodium \<129mEq/L.
- •6 Serum Creatinine \> 2 mg/dl.
- •7 Hepatocellular carcinoma or other malignancies
- •8 Active infectious disease.
- •9 Presence of severe underlying cardiac, pulmonary or renal disease.
- •10 Positive antibodies to HIV
Outcomes
Primary Outcomes
Not specified
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