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SNMC (Stronger Neo-Minophagen C ) for Acute Hepatitis Post Transarterial Chemoembolization Therapy

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Stronger Neo-Minophagen C
Sponsored by
Chimei Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring TACE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • ChiMei Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SNMC

non-SNMC

Arm Description

Outcomes

Primary Outcome Measures

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
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
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
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
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

Secondary Outcome Measures

Series changes of potassium levels before and after TACE
To evaluate the daily change of Series changes of potassium levels before and after TACE, which indicate the side effect caused by SNMC
Series changes of blood pressure levels before and after TACE
To evaluate the daily change of Series changes of blood pressure levels before and after TACE, which indicate the side effect caused by SNMC

Full Information

First Posted
May 28, 2019
Last Updated
July 9, 2019
Sponsor
Chimei Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04015245
Brief Title
SNMC (Stronger Neo-Minophagen C ) for Acute Hepatitis Post Transarterial Chemoembolization Therapy
Official Title
Benefits of SNMC (Stronger Neo-Minophagen C ) for Heptoma Patient With Acute Hepatitis Post Transarterial Chemoembolization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 12, 2018 (Actual)
Primary Completion Date
May 9, 2019 (Actual)
Study Completion Date
May 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chimei Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world and the most common primary liver cancer. There are a variety of therapies for treatment of HCC; among them, transarterial chemoembolization (TACE) is one of the most commonly used treatment modalities. TACE induces ischemic tumor necrosis by obstruction of hepatic artery blood flow and exerts an anticancer effect via chemotherapeutic agents such as adriamycin or cisplatin mixed with Lipiodol. In the American Association for the Study of Liver Diseases (AASLD) guidelines for the management of HCC, TACE is recommended for patients with intermediate-stage HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging system, because TACE was found to improve survival compared with the best supportive care in patients with unresectable HCC. Although TACE is the established standard of care only for intermediate-stage HCC, in recent years, TACE has been used widely even in treatment of advanced-stage HCC. The most frequent side effects of TACE are fever, nausea, and abdominal pain, and these side effects are self-limiting in the majority of patients. However, acute deterioration of hepatic function following TACE is a potentially life-threatening complication that occasionally interferes with continuation of TACE in patients with HCC. Although TACE has marked direct antitumor effects, it can also result in more complications than conservative management, because the ischemic damage caused by TACE can influence not only tumor tissue but non-tumorous liver tissue.This study aimed to evaluate the effect of SNMC on acute deterioration of hepatic function following TACE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
TACE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SNMC
Arm Type
Experimental
Arm Title
non-SNMC
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Stronger Neo-Minophagen C
Intervention Description
intravenous injection after TACE
Primary Outcome Measure Information:
Title
Series changes of serum levels of alanine aminotransferase
Description
To evaluate the daily change of serum levels of alanine aminotransferase before and after TACE, which indicate the hepatitis activity caused by TACE
Time Frame
4 days
Title
Series changes of serum levels of aspartate aminotransferase
Description
To evaluate the daily change of serum levels of aspartate aminotransferase before and after TACE, which indicate the hepatitis activity caused by TACE
Time Frame
4 days
Title
Series changes of serum levels of Total bilirubin
Description
To evaluate the daily change of serum levels of Total bilirubin before and after TACE, which indicate the hepatitis activity caused by TACE
Time Frame
4 days
Title
Series changes of Prothrombin Time
Description
To evaluate the daily change of Prothrombin Time before and after TACE, which indicate the hepatitis activity caused by TACE
Time Frame
4 days
Title
Series changes of Prothrombin Time-Intemrnational Normalized Ratio
Description
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
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Series changes of potassium levels before and after TACE
Description
To evaluate the daily change of Series changes of potassium levels before and after TACE, which indicate the side effect caused by SNMC
Time Frame
4 days
Title
Series changes of blood pressure levels before and after TACE
Description
To evaluate the daily change of Series changes of blood pressure levels before and after TACE, which indicate the side effect caused by SNMC
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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" Exclusion Criteria: 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)
Facility Information:
Facility Name
ChiMei Medical Center
City
Tainan
ZIP/Postal Code
71004
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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SNMC (Stronger Neo-Minophagen C ) for Acute Hepatitis Post Transarterial Chemoembolization Therapy

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