CirrhosisPhase 4NCT02755701
The Effect of Branched-chain Amino Acid on the Improvement of Serum Albumin Level in Cirrhotic Patients With Ascites
A Phase 4 study testing Branched-chain Amino Acid in people with Cirrhosis and Ascites, run by Soonchunhyang University Hospital at 8 sites in 2 countries.
Trial summary
To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic patients with ascites. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- What is being tested?
- Branched-chain Amino Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jul 2016to Dec 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 and ≤ 70 years;
- Presence of liver cirrhosis
- Serum albumin level ≤ 3.5g/dl, ultrasound or CT scan confirmed ascites (≥Grade 1)
- No administration of diuretics and BCAA within the past 1 week
- Voluntary consent to take part in this trial
Who cannot join
- Child-Pugh score > 12
- Having been diagnosed as HCC within the past 5 years
- Serum creatinine > 1.5mg/dl
- Serum bilirubin > 5.0mg/dl
- Presence of such complications as SBP, or hepatic encephalopathy(West Haven grade ≥ 3)
- Patients who experienced organ failure by acute exacerbation of liver cirrhosis within the past 1 month
Show all 14Show fewer
- Presence of serious cardiac or respiratory disease
- Contraindicated to either diuretics or BCAA
- Having commenced anti-viral treatment against hepatitis C, B within the past 1 month
- Pregnant or lactating women
- Chronic alcohol taker
- Woman patients who do not agree to the contraception from baseline to 12 month
- Unsuitable patients judged by investigator
- Patients participating in another clinical trial within 1 month
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
South Korea7 sites, 7 recruiting
- Recruiting
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 14584
Sang Gyune Kim, Professor, 82-32-621-5079, mcnulty@schmc.ac.kr
Sang Gyune Kim
- Recruiting
Kyunghee university hospital
Seoul, 02477
Jae Jun Shim, Professor
Jae Jun Shim
- Recruiting
Korea university anam hospital
Seoul, 02841
Yeon Seok Seo, Professor
Yeon Seok Seo
- Recruiting
Severance hospital
Seoul, 03722
Jun Yong Park, Professor
Jun Yong Park
- Recruiting
Soonchunhyang university seoul hospital
Seoul, 04401
Soung Won Jeong, Professor
Soung Won Jeong
- Recruiting
Hanyang university hospital
Seoul, 04763
Dae Won Jun, Professor
Dae Won Jun
- Recruiting
Wonju severance christian hospital
Wŏnju, Gangwon-do, 26426
Moon Young Kim, Professor
Moon Young Kim
United States1 site, 1 recruiting
- Not yet recruiting
Stanford University School of Medicine
Palo Alto, California, 94305
W.Ray Kim, Professor, 650-725-6511, wrkim@stanford.edu
W.Ray Kim, Professor
About this study
Official title: The Effect of Branched-chain Amino Acid on the Improvement of Serum Albumin Level in Cirrhotic Patients With Ascites: A Multi-center, Randomized, Double-blind, Placebo-controlled, Investigator Initiated Clinical Trial
To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic patients with ascites.
Read the detailed description
Branched-chain amino acid (BCAA) is known to reduce the relapse rate of liver cancer as it is associated with insulin resistance and has been reported to improve the progression of liver fibrosis when used in combination with an angiotensin-converting enzyme. With regard to the effect of liver function improvement, in a research conducted in South Korea, approximately 41.2% of the patients showed recovery of the normal albumin level when BCAA was administered to them for about 10 weeks during radiation therapy for liver cancer. Additionally, in other overseas researches, the changes in the values of total protein and albumin were significantly smaller in the patients who underwent transarterial chemoembolization (TACE) to whom BCAA was administered than in those to whom BCAA was not administered.
The hypothesis of this study is that the serum albumin value will be increased significantly in the cirrhotic patients with ascites to whom BCAA is administered than the patients to whom placebo is administered.
- Being tested
- Branched-chain Amino Acid, Placebo
- Medical subject headings
- Fibrosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branched-chain Amino AcidDrug
Also called Livact®
BCAA (livact) will be administered 3 times a day during 24 weeks
PlaceboDrug
Placebo will be administered in the same way
| Study group | Role | What they receive |
|---|---|---|
| BCAA group | Experimental | Branched-chain amino acid, 4.15g, Tid Receives: Drug: Branched-chain Amino Acid |
| Placebo group | Placebo comparator | Placebo, 4.15g, Tid Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum albumin level
Measured: 24 week
Secondary outcomes (12)
Change in serum albumin level
Measured: 12 week
Rates of albumin normalization
Measured: 12, 24 week
Change in dose of diuretics
Measured: 12, 24 week
Improvement in terms of severity of ascites (International Ascites Club grade)
Measured: 24 week
Development rate of cirrhotic complications(including acute kidney injury, hepatic encephalopathy, variceal bleeding, peritonitis, etc)
Measured: 24 week
Improvement in Child-Pugh score, class
Measured: 24 week
Change in MELD, MELD-Na
Measured: 24 week
Improvement in sarcopenia
Measured: 24 week
Change in muscle mass
Measured: 24 week
Change in muscle strength
Measured: 24 week
Improvement in SF-36(short form-36)
Measured: 24 week
Change in HOMA-IR(homeostatic model assessment-insulin resistance)
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, Kyunghee University, Wonju Severance Christian Hospital, Korea University Anam Hospital, Hanyang University, Stanford University
- Responsible party
- Principal investigator, Sang Gyune Kim, Soonchunhyang University Hospital
- Investigators
- Sang Gyune Kim, Principal investigator, Soon Chun Hyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755701
- Sponsor's protocol ID
- LIV_ACT Trial_I
- Status last verified
- Aug 2016
- First submitted
- 21 Apr 2016
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Branched-chain Amino Acid on the Improvement of Serum Albumin Level in Cirrhotic Patients With Ascites: A Multi-center, Randomized, Double-blind, Placebo-controlled, Investigator Initiated Clinical Trial
- ClinicalTrials.gov ID
- NCT02755701
- Acronym / sponsor ID
- LIV_ACT Trial_I
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Collaborators
- Severance Hospital, Kyunghee University, Wonju Severance Christian Hospital, Korea University Anam Hospital, Hanyang University, Stanford University
- Study start
- Jul 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Apr 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.
To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic patients with ascites.
Detailed description
Branched-chain amino acid (BCAA) is known to reduce the relapse rate of liver cancer as it is associated with insulin resistance and has been reported to improve the progression of liver fibrosis when used in combination with an angiotensin-converting enzyme. With regard to the effect of liver function improvement, in a research conducted in South Korea, approximately 41.2% of the patients showed recovery of the normal albumin level when BCAA was administered to them for about 10 weeks during radiation therapy for liver cancer. Additionally, in other overseas researches, the changes in the values of total protein and albumin were significantly smaller in the patients who underwent transarterial chemoembolization (TACE) to whom BCAA was administered than in those to whom BCAA was not administered.
The hypothesis of this study is that the serum albumin value will be increased significantly in the cirrhotic patients with ascites to whom BCAA is administered than the patients to whom placebo is administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCAA group | Experimental | Drug: Branched-chain Amino AcidBranched-chain amino acid, 4.15g, Tid |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo, 4.15g, Tid |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 19 and ≤ 70 years;
- Presence of liver cirrhosis
- Serum albumin level ≤ 3.5g/dl, ultrasound or CT scan confirmed ascites (≥Grade 1)
- No administration of diuretics and BCAA within the past 1 week
- Voluntary consent to take part in this trial
Key exclusion criteria (14 listed)
- Child-Pugh score > 12
- Having been diagnosed as HCC within the past 5 years
- Serum creatinine > 1.5mg/dl
- Serum bilirubin > 5.0mg/dl
- Presence of such complications as SBP, or hepatic encephalopathy(West Haven grade ≥ 3)
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 |
|---|---|---|
| Branched-chain Amino AcidAlso: Livact®BCAA (livact) will be administered 3 times a day during 24 weeks | Drug | BCAA group |
| PlaceboPlacebo will be administered in the same way | Drug | Placebo group |
Primary outcome
Change in serum albumin level
Time frame: 24 week
12 secondary outcomes
Change in serum albumin level
Time frame: 12 week
Rates of albumin normalization
Time frame: 12, 24 week
Change in dose of diuretics
Time frame: 12, 24 week
Improvement in terms of severity of ascites (International Ascites Club grade)
Time frame: 24 week
Development rate of cirrhotic complications(including acute kidney injury, hepatic encephalopathy, variceal bleeding, peritonitis, etc)
Time frame: 24 week
Improvement in Child-Pugh score, class
Time frame: 24 week
Change in MELD, MELD-Na
Time frame: 24 week
Improvement in sarcopenia
Time frame: 24 week
Change in muscle mass
Time frame: 24 week
Change in muscle strength
Time frame: 24 week
Improvement in SF-36(short form-36)
Time frame: 24 week
Change in HOMA-IR(homeostatic model assessment-insulin resistance)
Time frame: 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Sang Gyune Kim principal investigator
Soon Chun Hyang University
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Branched-chain Amino Acid in people with Cirrhosis and Ascites, run by Soonchunhyang University Hospital at 8 sites in 2 countries.
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 5 inclusion and 14 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 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea, United States. 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. Some participants in this study may receive a placebo. 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?
Contact Sang Gyune Kim (82-32-621-5079, mcnulty@schmc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum albumin level (time frame: 24 week). 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 2 Sep 2016.