Liver CirrhosisPhase 4BRAVENCT02837302
Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease
A Phase 4 study testing Livact in people with Liver Cirrhosis, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Livact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,470 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced liver cirrhosis patients with Child-Pugh score 8 to 10
Who cannot join
- Diagnosis of malignancy (except hepatocellular carcinoma) within 3 years or untreated malignancy
- Major organ failure (heart, lung and kidney) need to admission or medical therapy or dialysis
- Patients already on a waiting list or being considered for major organ transplantation.
- Serum creatinine above upper normal range (>1.5 mg/dL)
- Patients treating with albumin replacement regularly
- Viable hepatocellular carcinoma or advanced Barcelona Clinic Liver Cancer stage or hepatocellular carcinoma below 6 months life expectancy
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- Patients being impossible to secession of alcohol consumption
- Patients being impossible to oral ingestion or oral medication
- Pregnancy or being considered for pregnancy
- Breast feeding
- Amyotrophic lateral sclerosis
- Patients with other metabolic disorder presenting branched-chain ketoaciduria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease (BRAVE): Korean Nation-wide Multicenter Retrospective and Prospective Observational Cohort Study
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.
Read the detailed description
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.
- Conditions
- Liver Cirrhosis
- Being tested
- Livact
- Keywords
- Liver cirrhosis, Branched chain amino acid, End-Stage Liver Disease score
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LivactDrug
Also called Branched chain amino acid
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Livact |
| General nutritional support | No intervention | General nutritional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-Stage Liver Disease score was calculated using serum total bilirubin, creatinine, international normalized ratio
Measured: After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death
Secondary outcomes (1)
Incidence of cirrhosis-related complications including death
Measured: After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startNov 2012
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samil Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Won Young Tak, Kyungpook National University Hospital
- Investigators
- Won Young Tak, M.D., Ph.D., Principal investigator, Kyungpook national university hospital, department of internal medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837302
- Sponsor's protocol ID
- BRAVE_prospective
- Acronym
- BRAVE
- Status last verified
- Oct 2016
- First submitted
- 13 May 2014
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease (BRAVE): Korean Nation-wide Multicenter Retrospective and Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02837302
- Acronym / sponsor ID
- BRAVE / BRAVE_prospective
- Conditions
- Liver Cirrhosis
- Keywords
- Liver cirrhosis, Branched chain amino acid, End-Stage Liver Disease score
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,470 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Collaborators
- Samil Pharmaceutical Co., Ltd.
- Study start
- Nov 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Livact | Active comparator | Drug: LivactDaily 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Advanced liver cirrhosis patients with Child-Pugh score 8 to 10
Key exclusion criteria (12 listed)
- Diagnosis of malignancy (except hepatocellular carcinoma) within 3 years or untreated malignancy
- Major organ failure (heart, lung and kidney) need to admission or medical therapy or dialysis
- Patients already on a waiting list or being considered for major organ transplantation.
- Serum creatinine above upper normal range (>1.5 mg/dL)
- Patients treating with albumin replacement regularly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LivactAlso: Branched chain amino acidDaily 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. | Drug | Livact |
Primary outcome
End-Stage Liver Disease score was calculated using serum total bilirubin, creatinine, international normalized ratio
Time frame: After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death
1 secondary outcome
Incidence of cirrhosis-related complications including death
Time frame: After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Young Tak, M.D., Ph.D. principal investigator
Kyungpook national university hospital, department of internal medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Livact in people with Liver Cirrhosis, run by Kyungpook National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End-Stage Liver Disease score was calculated using serum total bilirubin, creatinine, international normalized ratio (time frame: After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.