NCT02755701

Brief Summary

To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic patients with ascites.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2016

Typical duration for phase_4

Geographic Reach
2 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 2, 2016

Status Verified

August 1, 2016

Enrollment Period

1.9 years

First QC Date

April 21, 2016

Last Update Submit

August 31, 2016

Conditions

CirrhosisAscites

Outcome Measures

Primary Outcomes (1)

  • Change in serum albumin level

    24 week

Secondary Outcomes (12)

  • Change in serum albumin level

    12 week

  • Rates of albumin normalization

    12, 24 week

  • Change in dose of diuretics

    12, 24 week

  • Improvement in terms of severity of ascites (International Ascites Club grade)

    24 week

  • Development rate of cirrhotic complications(including acute kidney injury, hepatic encephalopathy, variceal bleeding, peritonitis, etc)

    24 week

  • +7 more secondary outcomes

Other Outcomes (6)

  • Change in serum cystatin c

    12, 24 week

  • Change in HVPG(hepatic venous pressure gradient)

    24 week

  • Radiological characteristics of patients who have reaction to the branched-chain amino acid agent

    24 week

  • +3 more other outcomes

Study Arms (2)

BCAA group

EXPERIMENTAL

Branched-chain amino acid, 4.15g, Tid

Drug: Branched-chain Amino Acid

Placebo group

PLACEBO COMPARATOR

Placebo, 4.15g, Tid

Drug: Placebo

Interventions

Branched-chain Amino AcidDRUG

BCAA (livact) will be administered 3 times a day during 24 weeks

Also known as: Livact®
BCAA group
PlaceboDRUG

Placebo will be administered in the same way

Placebo group

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Stanford University School of Medicine

Palo Alto, California, 94305, United States

NOT YET RECRUITING

Wonju severance christian hospital

Wŏnju, Gangwon-do, 26426, South Korea

RECRUITING

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 14584, South Korea

RECRUITING

Kyunghee university hospital

Seoul, 02477, South Korea

RECRUITING

Korea university anam hospital

Seoul, 02841, South Korea

RECRUITING

Severance hospital

Seoul, 03722, South Korea

RECRUITING

Soonchunhyang university seoul hospital

Seoul, 04401, South Korea

RECRUITING

Hanyang university hospital

Seoul, 04763, South Korea

RECRUITING

MeSH Terms

Conditions

FibrosisAscites

Interventions

Amino Acids, Branched-Chain

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Sang Gyune Kim

    Soon Chun Hyang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Gyune Kim

CONTACT

82-32-621-5079mcnulty@schmc.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 21, 2016

First Posted

April 29, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

September 2, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)KR(7)