NCT04015245

Brief Summary

A glycyrrhizin-containing product, Stronger Neo-Minophagen C TM (SNMC; Minophagen Pharmaceutical Co.Ltd.,Tokyo,Japan),is widely used in Japan for suppression of hepatitis activity and for prevention of disease progression in patients with hepatitis B virus- and HCV-induced chronic hepatitis. In Taiwan, SNMC has been licensed by Taiwan Food and Drug Administration for the indication of maintain hepatic function. Glycyrrhizin has been reported to mitigate hepatic inflammation by suppressing elevated alanine aminotransferase(ALT) levels and preventing disease progression. The effect of SNMC on acute deterioration of hepatic function following transarterial chemoembolization (TACE) was still unknown. This study aimed to evaluate the effect of SNMC on acute deterioration of hepatic function following TACE.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 hepatocellular-carcinoma

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_4 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 12, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

May 28, 2019

Last Update Submit

July 9, 2019

Conditions

Hepatocellular Carcinoma

Keywords

TACE

Outcome Measures

Primary Outcomes (5)

  • Series changes of serum levels of alanine aminotransferase

    To evaluate the daily change of serum levels of alanine aminotransferase before and after TACE, which indicate the hepatitis activity caused by TACE

    4 days

  • Series changes of serum levels of aspartate aminotransferase

    To evaluate the daily change of serum levels of aspartate aminotransferase before and after TACE, which indicate the hepatitis activity caused by TACE

    4 days

  • Series changes of serum levels of Total bilirubin

    To evaluate the daily change of serum levels of Total bilirubin before and after TACE, which indicate the hepatitis activity caused by TACE

    4 days

  • Series changes of Prothrombin Time

    To evaluate the daily change of Prothrombin Time before and after TACE, which indicate the hepatitis activity caused by TACE

    4 days

  • Series changes of Prothrombin Time-Intemrnational Normalized Ratio

    To evaluate the daily change of Series changes of Prothrombin Time-Intemrnational Normalized Ratio before and after TACE, which indicate the hepatitis activity caused by TACE

    4 days

Secondary Outcomes (2)

  • Series changes of potassium levels before and after TACE

    4 days

  • Series changes of blood pressure levels before and after TACE

    4 days

Study Arms (2)

SNMC

EXPERIMENTAL
Drug: Stronger Neo-Minophagen C

non-SNMC

NO INTERVENTION

Interventions

Stronger Neo-Minophagen CDRUG

intravenous injection after TACE

SNMC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intermediate-stage HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging system, either treatment naïve or experienced.
  • Child's score belong to A or B(7)
  • Total bilirubin level \<2 and Prothrombin time prolong \<3"

You may not qualify if:

  • Had history of liver decompensation (ascites, encephalopathy, jaundice and varices bleeding) before this TACE
  • has allergic history of SNMC
  • consensus form cannot be available
  • hypokalemia (\<3.5 mmol/L)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChiMei Medical Center

Tainan, 71004, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

stronger neominophagen C

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending physician

Study Record Dates

First Submitted

May 28, 2019

First Posted

July 10, 2019

Study Start

April 12, 2018

Primary Completion

May 9, 2019

Study Completion

May 28, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)