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Study on the Optimal Strategy for Acute-on-chronic Liver Failure With Integrative Treatment

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ClinicalTrials.gov Identifier: NCT03577938
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
Beijing YouAn Hospital
ShuGuang Hospital
Sun Yat-sen University
Huazhong University of Science and Technology
Fuzhou Infectious Hospital
The sixth people's hospital of Shenyang
Public Health Clinical Center of Chengdu
Hepatology hospital of Jilin Province
Shanghai Public Health Clinical Center
Guangxi University of Chinese Medicine
Hubei Hospital of Traditional Chinese Medicine
Beijing Ditan Hospital
Shenzhen traditional Chinese medical hospital
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Shenzhen Third People's Hospital
Tianjin Second People's Hospital
Hangzhou Xixi hospital
Information provided by (Responsible Party):
Man Gong, Beijing 302 Hospital

Study Description
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Brief Summary:

Background: Acute-on-chronic liver failure (ACLF) is a syndrome characterized by acute deterioration in the setting of chronic liver disease associated with high short-term mortality. Currently, there is no specific treatment for patients with ACLF. Our previous results showed that Chinese herbal medicine (CHM) could reduce the mortality rate and the incidence of complications of ACLF effectively. In this study, we aim to conduct the multi-center randomized controlled trial to evaluate the effect of unified CHM formulas and provide propagable and high-level evidence for clinical practice.

Methods/design: This is a prospective, multicenter, centrally randomized controlled trial. Five hundred and ten patients diagnosed with HBV-related ACLF will be allocated in a 1:1 ratio to SMT group (standard medical therapy) and CHM group (CHM and SMT). The primary outcome is the transplant-free mortality rates at week 4, 8, 12, 24 and 48. Secondary outcomes include (1) the incidence of adverse reactions, (2) influence on liver function, (3) the incidence of serious complications and (4) the level of inflammatory cytokines.

Discussion: The effectiveness and safety of CHM formulas are assessed in the treatment of ACLF.


Condition or disease Intervention/treatment Phase
Acute on Chronic Liver Failure Traditional Chinese Medicine Hepatitis B Drug: Chinese herbal medicine Other: Control (blank) Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study on the Optimal Strategy for Acute-on-chronic Liver Failure Combined With Traditional Chinese and Modern Medicine: a Multi-center, Randomized and Controlled Study
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herbal Medicine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Chinese herbal medicine
One dosage of Chinese herbal medicine by oral administration per day for 8 weeks. For patients who cannot take oral medicine can be switched to colon route by the colonic therapy system（IMS-100A produced by Sunny Medical in Beijing China).
 Drug: Chinese herbal medicine
One dosage of CHM includes Artemisiacapillaris Thunb (30g), Salvia miltiorrhiza Bge (30g), Rhizoma Atractylodis Macroce- phalae (30g), Rubia cordifolia L (30g), Sieyesbeckiaorientalis L (30g). Paeoniae Radix Rubra (60g), Gardenia jasminoides Ellis (9g), Hedyotis diffusa Willd (30g) and Bletilla striata (15g) are involved for excess syndrome, and Astragalus membranaceus (30g), Radix Pseudostellariae (15g), Radix Aconiti Lateralis Praeparata (10g), Galli Gigeriae Endothelium Corneum (20g), Polygonum cuspidatum Sieb.et Zucc (15g) are involved for deficiency syndrome.
Other Name: CHM+SMT therapy

Other: Control (blank)
SMT therapy includes a high-calorie diet; nucleoside analogues for HBV DNA-positive patients; sodium restriction, diuretics and paracentesis combined with albumin infusion for ascites; lactulose and L-ornithine aspartate and lactulose for HE and hyper-ammonia; hemostatic treatment for gastrointestinal hemorrhage; antibiotics for infections and renal replacement for HRS and uremic symptoms.
Other Name: SMT therapy
Control (blank)
Patients in the control group only receive the standard medical treatment (SMT), no control drug with CHM.
 Other: Control (blank)
SMT therapy includes a high-calorie diet; nucleoside analogues for HBV DNA-positive patients; sodium restriction, diuretics and paracentesis combined with albumin infusion for ascites; lactulose and L-ornithine aspartate and lactulose for HE and hyper-ammonia; hemostatic treatment for gastrointestinal hemorrhage; antibiotics for infections and renal replacement for HRS and uremic symptoms.
Other Name: SMT therapy


Outcome Measures
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Primary Outcome Measures :
  1. transplant free survival [ Time Frame: week 12 ]
    transplant free survival at the time point of week 12


Secondary Outcome Measures :
  1. transplant free survival [ Time Frame: week 24 ]
    transplant free survival at the time point of week 24

  2. liver function assessed by MELD score [ Time Frame: week 12 ]
    compare the MELD score between the two arms. MELD is the abbreviation of model for end-stage liver disease involving serum bilirubin, creatinine, international normalized ratio (INR) and sodium.

  3. liver function assessed by Child-Pugh score [ Time Frame: week 12 ]
    compare the Child-Pugh score between the two arms. Child-Pugh score is the panel involving the serum bilirubin, coagulation function, albumin and the complication of hepatic encephalopathy and ascites.

  4. Quality of life assessed by WHOQOL-BRIEF [ Time Frame: week 12 ]
    compare the life quality based on WHOQOL-BRIEF between the two arms

  5. incidence of complications [ Time Frame: from week 1 to week 12 ]
    incidence of liver related complications of the two arms including infections, encephalopathy, hepatorenal syndrome (HRS), and gastrointestinal bleeding.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In-patients with acute-on-chronic liver failure;
  • Patients with chronic hepatitis B or compensatory cirrhosis of hepatitis B;
  • Patients who is willing to sign the informed consent;
  • Patients aged among 16~65 years old.

Exclusion Criteria:

  • Acute liver failure, or sub acute liver failure, or chronic liver failure;
  • Acute-on-chronic liver failure not caused by hepatitis B but other disease such as autoimmune, drug, alcohol, toxic, parasites;
  • Pregnant or lactating women;
  • Primary liver cancer;
  • Combined with other severe systematic disease and mental disease;
  • Anti-HIV positive or combined with infection of hepatitis A, C, D, E virus or cytomegalovirus, Epstein-Barr virus;
  • Enrolled in other clinical studies in last three months;
  • Person unwilling to cooperate; 9. poor compliance, unable guarantee completing the protocol;
  • Complicated with severe cerebral edema, severe infection, type I liver-kidney symptom, and gastrointestinal hemorrhage.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577938


Contacts
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Contact: Man Gong +8613910123785 gongman302@163.com
Contact: Ning Zhang +8615010807936 zhangning198191@sina.com

Locations
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China, Beijing
302 military hospital of China Recruiting
Beijing, Beijing, China
Contact: Ning Zhang    +8615010807936    zhangning198191@sina.com   
Beijing Ditan hospital Recruiting
Beijing, Beijing, China
Contact: Xianbo Wang    +861301001598    wangxianbo638@163.com   
Beijing youan hospital Recruiting
Beijing, Beijing, China
Contact: Xiuhui Li    +861351273210    lixiuhui@sohu.com   
China, Fujian
Fuzhou infectious hospital Recruiting
Fuzhou, Fujian, China, 350025
Contact: Zhengfang Liu    +8618906938388    zhengfang1683399@126.com   
Xiamen hospital of traditional Chinese medicine Recruiting
Xiamen, Fujian, China
Contact: Jinmo Tang    +8613850085858    13850085858@163.com   
China, Hubei
Hubei hospital of traditional Chinese medicine Recruiting
Wuhan, Hubei, China
Contact: Hanmin Li    +8613018089519    lihanmin69@126.com   
Tongji hospital, Huazhong university of science and technology Recruiting
Wuhan, Hubei, China
Contact: Zhengang Zhang    +8613071289626    zhangzhg@126.com   
China, Hunan
The first affiliated hospital of Hunan university of traditional Chinese medicine Recruiting
Changsha, Hunan, China, 410000
Contact: Kewei Sun    +86158731490458    keweisun550@163.com   
China, Jilin
Jilin hepatology hospital Recruiting
Changchun, Jilin, China
Contact: Shuqin Zhang    +8613894892233    zhangshuqin2009@126.com   
China, Liaoning
The sixth people's hospital of Shenyang Recruiting
Shenyang, Liaoning, China
Contact: Ye Gu    +8618502460001    gu3311@126.com   
China, Shanghai
Shanghai public health clinical center Recruiting
Shanghai, Shanghai, China
Contact: Jiefei Wang    +861381901651    wjf_sm@126.com   
Shuguang hospital, Shanghai university of traditional Chinese medicine Recruiting
Shanghai, Shanghai, China
Contact: Yunhui Zhuo    +861396043598    huihuiz1688@hotmail.com   
China, Sichuan
Chengdu public health clinical center Recruiting
Chengdu, Sichuan, China
Contact: Lin Wang    +8613881731673    wang02736@sina.com   
China, Tianjin
The second people's hospital of Tianjin Recruiting
Tianjin, Tianjin, China
Contact: Wukui Cao    +861382186563    tjcaowk@sina.com   
China, Zhejiang
Hangzhou Xixi hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Jianchun Guo    +861398107528    guojianchun1961@126.com   
Sponsors and Collaborators
Beijing 302 Hospital
Beijing YouAn Hospital
ShuGuang Hospital
Sun Yat-sen University
Huazhong University of Science and Technology
Fuzhou Infectious Hospital
The sixth people's hospital of Shenyang
Public Health Clinical Center of Chengdu
Hepatology hospital of Jilin Province
Shanghai Public Health Clinical Center
Guangxi University of Chinese Medicine
Hubei Hospital of Traditional Chinese Medicine
Beijing Ditan Hospital
Shenzhen traditional Chinese medical hospital
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Shenzhen Third People's Hospital
Tianjin Second People's Hospital
Hangzhou Xixi hospital
Investigators
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Study Chair: Man Gong, Doctor Beijing 302 Hospital
Principal Investigator: Kewei Sun The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Principal Investigator: Zhengfang Liu Fuzhou Infectious Hospital
Principal Investigator: Jiefei Wang Shanghai Public Health Clinical Center
Principal Investigator: Yunhui Zhuo Shuguang hospital of Shanghai university of traditional Chinese medicine
Principal Investigator: Shuqin Zhang Jilin hematology hospital
Principal Investigator: Wukui Cao Tianjin Second People's Hospital
Principal Investigator: Zhengang Zhang Tongji Hospital
Principal Investigator: Lin Wang Chengdu public health clinical center
Principal Investigator: Ye Gu The sixth people's hospital of Shenyang
Principal Investigator: Jianchun Guo Hangzhou Xixi hospital
Principal Investigator: Xianbo Wang Beijing Ditan Hospital
Principal Investigator: Xiuhui Li Beijing YouAn Hospital
Principal Investigator: Xiaozhou Zhou Shenzhen Traditional Chinese Medicine Hospital
Principal Investigator: Jinmo Tang Xiamen traditional Chinese medicine hospital
Principal Investigator: Hanmin Li Hubei traditional Chinese medicine hospital
  Study Documents (Full-Text)

Documents provided by Man Gong, Beijing 302 Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] June 21, 2018

More Information
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Responsible Party: Man Gong, Professor, Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT03577938     History of Changes
Other Study ID Numbers: 2018ZX10725506-002
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Man Gong, Beijing 302 Hospital:
Liver Failure
traditional Chinese medicine
Hepatitis B
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Diseases
 Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Liver Failure, Acute