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出境医 / 临床实验 / SNMC (Stronger Neo-Minophagen C ) for Acute Hepatitis Post Transarterial Chemoembolization Therapy

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

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Stronger Neo-Minophagen C Phase 4

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized control trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Benefits of SNMC (Stronger Neo-Minophagen C ) for Heptoma Patient With Acute Hepatitis Post Transarterial Chemoembolization Therapy
Actual Study Start Date : April 12, 2018
Actual Primary Completion Date : May 9, 2019
Actual Study Completion Date : May 28, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: SNMC Drug: Stronger Neo-Minophagen C
intravenous injection after TACE
No Intervention: non-SNMC
Outcome Measures
Primary Outcome Measures :
  1. Series changes of serum levels of alanine aminotransferase [ Time Frame: 4 days ]
    To evaluate the daily change of serum levels of alanine aminotransferase before and after TACE, which indicate the hepatitis activity caused by TACE

  2. Series changes of serum levels of aspartate aminotransferase [ Time Frame: 4 days ]
    To evaluate the daily change of serum levels of aspartate aminotransferase before and after TACE, which indicate the hepatitis activity caused by TACE

  3. Series changes of serum levels of Total bilirubin [ Time Frame: 4 days ]
    To evaluate the daily change of serum levels of Total bilirubin before and after TACE, which indicate the hepatitis activity caused by TACE

  4. Series changes of Prothrombin Time [ Time Frame: 4 days ]
    To evaluate the daily change of Prothrombin Time before and after TACE, which indicate the hepatitis activity caused by TACE

  5. Series changes of Prothrombin Time-Intemrnational Normalized Ratio [ Time Frame: 4 days ]
    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 :
  1. Series changes of potassium levels before and after TACE [ Time Frame: 4 days ]
    To evaluate the daily change of Series changes of potassium levels before and after TACE, which indicate the side effect caused by SNMC

  2. Series changes of blood pressure levels before and after TACE [ Time Frame: 4 days ]
    To evaluate the daily change of Series changes of blood pressure levels before and after TACE, which indicate the side effect caused by SNMC


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Locations
Layout table for location information
Taiwan
ChiMei Medical Center
Tainan, Taiwan, 71004
Sponsors and Collaborators
Chimei Medical Center
Tracking Information
First Submitted Date  ICMJE May 28, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE April 12, 2018
Actual Primary Completion Date May 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Series changes of serum levels of alanine aminotransferase [ Time Frame: 4 days ]
    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 [ Time Frame: 4 days ]
    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 [ Time Frame: 4 days ]
    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 [ Time Frame: 4 days ]
    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 [ Time Frame: 4 days ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Series changes of potassium levels before and after TACE [ Time Frame: 4 days ]
    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 [ Time Frame: 4 days ]
    To evaluate the daily change of Series changes of blood pressure levels before and after TACE, which indicate the side effect caused by SNMC
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SNMC (Stronger Neo-Minophagen C ) for Acute Hepatitis Post Transarterial Chemoembolization Therapy
Official Title  ICMJE Benefits of SNMC (Stronger Neo-Minophagen C ) for Heptoma Patient With Acute Hepatitis Post Transarterial Chemoembolization Therapy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized control trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE Drug: Stronger Neo-Minophagen C
intravenous injection after TACE
Study Arms  ICMJE
  • Experimental: SNMC
    Intervention: Drug: Stronger Neo-Minophagen C
  • No Intervention: non-SNMC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2019) 		60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 28, 2019
Actual Primary Completion Date May 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015245
Other Study ID Numbers  ICMJE CMMC10702-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hsing-Tao Kuo, Chimei Medical Center
Study Sponsor  ICMJE Chimei Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chimei Medical Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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