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Completed

NCT Number: NCT04015245

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ChiMei Medical Center

Tainan, 71004, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Stronger Neo-Minophagen C

Drug

intravenous injection after TACE

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chimei Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 10, 2019
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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