Health Condition 1: K769- Liver disease, unspecified
Conditions
Interventions
Intervention1: Ademetionine 1,4-Butane Disulfonate 500 mg Lyophilized Powder for Injection: The recommended dosing is 5-12 mg/kg/day IV or IM. The usual starting dose is 500 mg/day IV or IM for 2 week
Sponsors
La Renon Healthcare Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged between 18 to 65 years (both inclusive). 2. Patients with diagnosis of intrahepatic cholestasis (IHC): Serum total bilirubin and serum conjugated bilirubin levels more than 2 times upper limit of normal (ULN). Alkaline phosphatase (ALP) and / or Gamma glutamyl transferase (GGT) more than 2 times upper limit of normal (ULN). 3. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit. 4. Patient with ability to understand and provide written, signed and dated informed consent form, which must have been obtained prior to screening. 5. Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with a known hypersensitivity to the active substance of Ademetionine. 2. Patients with a history of consumption of steatogenic medications in the 6 months prior to screening, such as Amiodarone, Methotrexate, Tamoxifen, Valproate, anti-retroviral medicine, NSAIDs, statins, neuroleptics, anti-convulsants, corticosteroids, etc. as per available records. 3. Patients with a history of other causes of chronic liver disease (NAFLD, autoimmune liver diseases, viral hepatitis (Hepatitis B virus and Hepatitis C virus), Wilsonâ??s disease, hemochromatosis) and metabolic syndrome. 4. Patients with a history of severe liver disease such as with Child-Pugh Class B or C and with any end-stage liver disease. 5. Patients with known or history of genetic defects affecting the methionine cycle and/or causing homocystinuria and/or hyperhomocysteinemia (e.g., cystathionine beta-synthase deficiency, Vitamin B12 metabolism defect) or known folate, Vitamin B6 or B12 deficiency). 6. Patients with renal dysfunction (serum creatinine >= 2.5 mg/dL). 7. Patients with history of liver transplantation. 8. Patients with a history of active heavy alcohol intake (Greater than 150 g/day). 9. Patients who require ICU setting management. 10. Patients on any treatment with other drugs claimed for treatment of alcoholic liver disease (i.e., Pentoxyphylline, steroids, Ursodeoxycholic Acid, acetyl cholinesterase enzyme inhibitors antioxidants such as Vitamin E, Vitamin C, GSH, alpha-tocopherol, or non-prescribed complementary alternative medications [including dietary supplements]). 11. Patients with extrahepatic cause of cholestasis (proven by ultrasound or described in medical history). 12. Patients with a history of active substance abuse (oral, inhaled or injected) within one year prior to the study. 13. Patients on total parenteral nutrition in the year prior to screening. 14. Patients after or planned for bariatric surgery (jejunoileal bypass or gastric weight loss surgery). 15. Patients with any of the following disease in medical history: Evidence of autoimmune liver disease Wilsonâ??s disease Hemochromatosis Alpha-1-antitrypsin deficiency 16. Patients with a history of biliary diversion. 17. Patients with a history of major depression or bipolar disease. 18. Patients with a known case of clinically significant cerebrovascular disease, cardiovascular disease, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension, collagen disorders, severe infections, that may affect patient safety. 19. Patients with any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patientâ??s participation in the study. 20. Female patients who are pregnant or breast-feeding or expecting to conceive within the projected duration of the study. 21. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device). 22. Patients with a history of any malignancy. 23. Patients with history of ascites, hepatic encephalopathy, varices or bleeding. 24. Patients with concurrent participation in another clinical trial or any investigational therapy within 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in serum total bilirubin and serum conjugated bilirubin from baseline to end of the study visit (week 2).Timepoint: Visit 1 - Screening or Baseline visit (Day -3), Visit 3 - Follow up visit / week 1 (Day 8±1) and Visit 4 - End of the study visit / Week 2 (Day 15±2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in alkaline phosphatase (ALP) from baseline to end of the study visit (week 2).Timepoint: Visit 1 - Screening or Baseline visit (Day -3), Visit 3 - Follow up visit / week 1 (Day 8±1) and Visit 4 - End of the study visit / Week 2 (Day 15±2). ;Mean change in gamma glutamyl transferase (GGT) from baseline to end of the study visit (week 2).Timepoint: Visit 1 - Screening or Baseline visit (Day -3), Visit 3 - Follow up visit / week 1 (Day 8±1) and Visit 4 - End of the study visit / Week 2 (Day 15±2).;Mean change in hepatic transaminases (i.e., SGOT and SGPT) from baseline to end of the study visit (week 2).Timepoint: Visit 1 - Screening or Baseline visit (Day -3), Visit 3 - Follow up visit / week 1 (Day 8±1) and Visit 4 - End of the study visit / Week 2 (Day 15±2).;Changes in clinical symptoms of cholestasis (pruritus, fatigue and jaundice) as assessed by the investigator from baseline to end of the study visit (week 2).Timepoint: Visit 1 - Screening or Baseline visit (Day -3), Visit 3 - Follow up visit / week 1 (Day 8±1) and Visit 4 - End of the study visit / Week 2 (Day 15±2).;Adverse events or Serious adverse events reported during the study.Timepoint: Throughout the study;Changes in clinical laboratory parameters from baseline to end of the study visit (week 2).Timepoint: Visit 1 - Screening or Baseline visit (Day -3) and Visit 4 - End of the study visit / Week 2 (Day 15±2). | — |
Countries
India
Contacts
Public ContactDr Harsh Shah
La Renon Healthcare Pvt. Ltd.
Outcome results
None listed