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

Hepatocellular Carcinoma Clinical Trial

Official title:

Benefits of SNMC (Stronger Neo-Minophagen C ) for Heptoma Patient With Acute Hepatitis Post Transarterial Chemoembolization Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04015245
• Other study ID #: CMMC10702-001
• Status: Completed
• Phase: Phase 4
• Start date: April 12, 2018
• Est. completion date: May 28, 2019

Study information

• Verified date: July 2019
• Source: Chimei Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 28, 2019
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Stronger Neo-Minophagen C
intravenous injection after TACE

Locations

Country	Name	City	State
Taiwan	ChiMei Medical Center	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Chimei Medical Center

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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	4 days
Secondary	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	4 days