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| Name | Class |
|---|---|
| Samil Pharmaceutical Co., Ltd. | INDUSTRY |
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Protein-calorie malnutrition is frequently observed in patients with advanced liver cirrhosis. There have been continued interests in potential benefits of long-term oral branched-chain amino acid supplement in improving severity of liver disease. However, there are limited evidences in literature. The aim of this study is to evaluate the efficacy of oral branched-chain amino acid in patients with advanced liver cirrhosis.
This study is a multicenter retrospective cohort study involving thirteen centers in Korea nation-wide. The inclusion criteria are liver cirrhosis patients with Child-Pugh score 8 to 10. The major exclusion criteria are abnormal serum creatinine level, and hepatocellular carcinoma with viable tumor. The investigators analyzed improvement of Model for End-Stage Liver Disease score, Child-Pugh score, incidence of cirrhosis-related complications, and event free survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Livact | Active Comparator | Daily dose of 12.45g of branched-chain amino acid containing 3.4g of L-valine, 5.7g of L-leucine, and 2.9g of L-isoleucine over 6 months. |
|
| General nutritional support | No Intervention | General nutritional support |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Livact | Drug | Daily dose of 12.45g of branched-chain amino acid containing 3.4g of L-valine, 5.7g of L-leucine, and 2.9g of L-isoleucine over 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| End-Stage Liver Disease score was calculated using serum total bilirubin, creatinine, international normalized ratio | After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cirrhosis-related complications including death | After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Won Young Tak, M.D., Ph.D. | Kyungpook national university hospital, department of internal medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook national university hospital | Daegu | 700-721 | South Korea |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000597 | Amino Acids, Branched-Chain |
| ID | Term |
|---|---|
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |