Hepatocellular CarcinomaPhase 4NCT04015245
SNMC (Stronger Neo-Minophagen C ) for Acute Hepatitis Post Transarterial Chemoembolization Therapy
A Phase 4 study testing Stronger Neo-Minophagen C in people with Hepatocellular Carcinoma, run by Chimei Medical Center at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Stronger Neo-Minophagen C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Apr 2018to 28 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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"
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of SNMC (Stronger Neo-Minophagen C ) for Heptoma Patient With 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Stronger Neo-Minophagen C
- Keywords
- TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stronger Neo-Minophagen CDrug
intravenous injection after TACE
| Study group | Role | What they receive |
|---|---|---|
| SNMC | Experimental | Not described Receives: Drug: Stronger Neo-Minophagen C |
| non-SNMC | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 4 days
Secondary outcomes (2)
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
Measured: 4 days
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
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start12 Apr 2018
- Primary completion9 May 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsing-Tao Kuo, Chimei Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015245
- Sponsor's protocol ID
- CMMC10702-001
- Status last verified
- Jul 2019
- First submitted
- 28 May 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of SNMC (Stronger Neo-Minophagen C ) for Heptoma Patient With Acute Hepatitis Post Transarterial Chemoembolization Therapy
- ClinicalTrials.gov ID
- NCT04015245
- Acronym / sponsor ID
- CMMC10702-001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- TACE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| SNMC | Experimental | Drug: Stronger Neo-Minophagen C |
| non-SNMC | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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"
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stronger Neo-Minophagen Cintravenous injection after TACE | Drug | SNMC |
Primary outcome
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
2 secondary outcomes
Series changes of potassium levels before and after TACE
Time frame: 4 days
Series changes of blood pressure levels before and after TACE
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stronger Neo-Minophagen C in people with Hepatocellular Carcinoma, run by Chimei Medical Center at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Series changes of serum levels of alanine aminotransferase (time frame: 4 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.