BCAA Granule for patients with Hepatitis C virus-related Liver Cirrhosis and Insulin Resistance On the Effect of Reduction of Carcinogenic RisK in the Liver

Phase 3

• Conditions: Hepatitis c virus related liver cirrhosis

• Registration Number: JPRN-UMIN000006978
• Lead Sponsor: Japan Liver Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-01
• Study Completion: 2016-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

1) Oral administration of BCAA or nutritional sulpplement including BCAA within 4 weeks prior to study entry 2) HBV infection 3) History of hepatic encephalopathy 4) Serum bilirubin levels >= 3.0mg/dl 5) Uncontrollable ascites or edema or pleural effusion 6) Cirrhotic status of Child-Pugh B or C 7) Alcohol abuse 8) High risk of rupture of esophageal varices 9) Renal failure 10) congenital disorders of aminoacid metabolism 11) Diabetes mellitus requiring medication 12) Interferon therapy 13) History of hepatocellular carcinoma 14) History of malignant tumors 15) Severe heart disease 16) Severe and active infection 17) Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry. 18) Embolization or infarction within 6 months prior to study entry. 19) Surgical procedure within 4 weeks prior to start of study drug 20) History of organ allograft 21) Bone marrow transplantation or peripheral blood stemcell transplantation within 4 weeks prior to study entry 22) Patients unable to swallow oral medications 23) Any gastrointestinal disease or disorder that may affect to the absorption of drug or pharmacokinetics 24) Medication that may affect to the absorption of drug or pharmacokinetics. 25) Any disease or disorder that may affect the evaluation of study drug. 26) Entry to the other clinical trial within 4 weeks prior to entry to this study. 27) Pregnant or breast-feeding patients 28) Known allergy to the investigational agent or any agent given in association with this trial 29) Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patient's participation in the study or evaluation of the stuy results. 30) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to hepatic carcinogenesis

Secondary Outcome Measures

Name	Time	Method
Time to progression of liver cirrrhosis The change in serum albumin level The change in markers of glucose metabolism