Hepatocellular CarcinomaNCT01643447
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)
A study testing Ulinastatin and Diammonium glycyrrhizinate in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
The purpose of this study is to confirm that Ulinastatin is a safe and effective drug and it can reduce the incidence of postoperative hepatic failure in HCC patients. To evaluate that Ulinastatin can improve survival in HCC patients or not. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Ulinastatin and Diammonium glycyrrhizinate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Apr 2015
- Phase
- Interventional
- 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients > 35 years and <=55 years of age.
- confirmed case (patients with HCC)
- Tumors can be radical removed and resection volume was 50% to 70%.
- Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
- No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³.
- Karnofsky Performance Score performance over 60.
- Patients who can understand this trial and have signed information consent.
Who cannot join
- Patients who have undergone previous treatment by Ulinastatin.
- Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.
- Patients with other diseases which may affect the treatment mentioned here.
- Patients with medical history of other malignant tumors.
- Subjects participating in other clinical trials.
- Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C.
- Patients would not sign the consent to the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality
About this study
Official title: A Prospective Randomized Trial Comparing Ulinastatin's Drug Protection in Hepatocellular Carcinoma(HCC)Patients'Postoperative Hepatic Failure
The purpose of this study is to confirm that Ulinastatin is a safe and effective drug and it can reduce the incidence of postoperative hepatic failure in HCC patients. To evaluate that Ulinastatin can improve survival in HCC patients or not.
Read the detailed description
Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad, still shows a rising trend. Postoperative hepatic failure remains a major reason of liver resection's failure.
- As broad spectrum of enzyme inhibitors, Ulinastatin has the valid therapeutical effect of hepatic failure and hepatic ischemia-reperfusion injury in animal experiment. And it restrain inflammatory mediator to release. But it's lack of clinical evidence that Ulinastatin reduce the incidence of postoperative hepatic failure in HCC patients The purpose of the study is to assess the effort for comparing Ulinastatin's drug protection in patients with hepatocellular carcinoma (HCC) for postoperative hepatic failure and to evaluate that Ulinastatin can improve survival in HCC patients or not.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Ulinastatin, Diammonium glycyrrhizinate
- Keywords
- Hepatocellular Carcinoma, Ulinastatin, Hepatic Failure
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlinastatinDrug
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)
Diammonium glycyrrhizinateDrug
| Study group | Role | What they receive |
|---|---|---|
| Diammonium glycyrrhizinate | Active comparator | Conventional drugs protect liver Receives: Drug: Diammonium glycyrrhizinate |
| Ulinastatin | Experimental | Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC) Receives: Drug: Ulinastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the overall survival rate of each group
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionApr 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Li Aijun, MD, Study chair, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643447
- Sponsor's protocol ID
- EHBH-RCT-2012-001
- Status last verified
- Mar 2016
- First submitted
- 16 Jul 2012
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Ulinastatin's Drug Protection in Hepatocellular Carcinoma(HCC)Patients'Postoperative Hepatic Failure
- ClinicalTrials.gov ID
- NCT01643447
- Acronym / sponsor ID
- EHBH-RCT-2012-001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Ulinastatin, Hepatic Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 18 Jul 2012 (estimated)
- 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.
The purpose of this study is to confirm that Ulinastatin is a safe and effective drug and it can reduce the incidence of postoperative hepatic failure in HCC patients. To evaluate that Ulinastatin can improve survival in HCC patients or not.
Detailed description
Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad, still shows a rising trend. Postoperative hepatic failure remains a major reason of liver resection's failure.
- As broad spectrum of enzyme inhibitors, Ulinastatin has the valid therapeutical effect of hepatic failure and hepatic ischemia-reperfusion injury in animal experiment. And it restrain inflammatory mediator to release. But it's lack of clinical evidence that Ulinastatin reduce the incidence of postoperative hepatic failure in HCC patients The purpose of the study is to assess the effort for comparing Ulinastatin's drug protection in patients with hepatocellular carcinoma (HCC) for postoperative hepatic failure and to evaluate that Ulinastatin can improve survival in HCC patients or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diammonium glycyrrhizinate | Active comparator | Drug: Diammonium glycyrrhizinateConventional drugs protect liver |
| Ulinastatin | Experimental | Drug: UlinastatinUlinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC) |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female patients > 35 years and <=55 years of age.
- confirmed case (patients with HCC)
- Tumors can be radical removed and resection volume was 50% to 70%.
- Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
- No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³.
Key exclusion criteria (7 listed)
- Patients who have undergone previous treatment by Ulinastatin.
- Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.
- Patients with other diseases which may affect the treatment mentioned here.
- Patients with medical history of other malignant tumors.
- Subjects participating in other clinical trials.
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 |
|---|---|---|
| UlinastatinUlinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC) | Drug | Ulinastatin |
| Diammonium glycyrrhizinate | Drug | Diammonium glycyrrhizinate |
Primary outcome
the overall survival rate of each group
Time frame: 3 years
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 31 Mar 2016.
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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.
Li Aijun, MD study chair
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulinastatin and Diammonium glycyrrhizinate in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
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 7 inclusion and 7 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 31 Mar 2016. 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 China. 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.
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?
the overall survival rate of each group (time frame: 3 years). 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 31 Mar 2016.