NCT03577938

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
516

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2.5 years

First QC Date

June 5, 2018

Last Update Submit

March 28, 2022

Conditions

Acute on Chronic Liver FailureTraditional Chinese MedicineHepatitis B

Keywords

Liver Failuretraditional Chinese medicineHepatitis B

Outcome Measures

Primary Outcomes (1)

  • transplant free survival

    transplant free survival at the time point of week 12

    week 12

Secondary Outcomes (5)

  • transplant free survival

    week 24

  • liver function assessed by MELD score

    week 12

  • liver function assessed by Child-Pugh score

    week 12

  • Quality of life assessed by WHOQOL-BRIEF

    week 12

  • incidence of complications

    from week 1 to week 12

Study Arms (2)

Chinese herbal medicine

EXPERIMENTAL

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 medicineOther: Control (blank)

Control (blank)

OTHER

Patients in the control group only receive the standard medical treatment (SMT), no control drug with CHM.

Other: Control (blank)

Interventions

Chinese herbal medicineDRUG

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.

Also known as: CHM+SMT therapy
Chinese herbal medicine
Control (blank)OTHER

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.

Also known as: SMT therapy
Chinese herbal medicineControl (blank)

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

302 military hospital of China

Beijing, Beijing Municipality, China

Location

Beijing Ditan hospital

Beijing, Beijing Municipality, China

Location

Beijing youan hospital

Beijing, Beijing Municipality, China

Location

Fuzhou infectious hospital

Fuzhou, Fujian, 350025, China

Location

Xiamen hospital of traditional Chinese medicine

Xiamen, Fujian, China

Location

Hubei hospital of traditional Chinese medicine

Wuhan, Hubei, China

Location

Tongji hospital, Huazhong university of science and technology

Wuhan, Hubei, China

Location

The first affiliated hospital of Hunan university of traditional Chinese medicine

Changsha, Hunan, 410000, China

Location

Jilin hepatology hospital

Changchun, Jilin, China

Location

The sixth people's hospital of Shenyang

Shenyang, Liaoning, China

Location

Shanghai public health clinical center

Shanghai, Shanghai Municipality, China

Location

Shuguang hospital, Shanghai university of traditional Chinese medicine

Shanghai, Shanghai Municipality, China

Location

Chengdu public health clinical center

Chengdu, Sichuan, China

Location

The second people's hospital of Tianjin

Tianjin, Tianjin Municipality, China

Location

Hangzhou Xixi hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver FailureHepatitis BLiver Failure

Condition Hierarchy (Ancestors)

Liver Failure, AcuteHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis

Study Officials

  • Man Gong, Doctor

    Beijing 302 Hospital

    STUDY CHAIR

  • 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

    Affiliated Hospital of Nanjing University of Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Jinmo Tang

    Xiamen Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Hanmin Li

    Hubei traditional Chinese medicine hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 5, 2018

First Posted

July 5, 2018

Study Start

January 10, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(15)