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A Study Evaluating the Efficacy of Glucocorticoids in Patients With Pre-ACLF-HBV (preACLF)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Third Military Medical University.
Recruitment status was:  Recruiting
Information provided by:
Third Military Medical University Identifier:
First received: April 21, 2011
Last updated: June 2, 2011
Last verified: June 2011

This is a randomized, open label study evaluating the efficacy and safety of glucocorticoids in patients with HBV associated pre-ACLF.

Sponsor: Department of infectious diseases, Southwest Hospital.

Indication: HBV associated acute-on-chronic pre-liver failure(pre-ACLF-HBV).

Objective: To evaluate the efficacy and safety of glucocorticoids in patients with pre-ACLF-HBV.

Trial Design: Randomized, open label study. Patients with pre-ACLF-HBV will be randomized 1:1 to One of the two groups:

A)Dexamethasone 10mg were intravenously injected po daily for the first 5 days, in combination with continued lamivudine 100mg po daily and traditional supporting treatments for 13 weeks. B)Control group. Any glucocorticoids will be not given in all patients. Continued lamivudine 100mg po daily and traditional supporting treatments will be given for 13 weeks.

Number of patients: Approximate number of patients to be randomized: N=200 (100 patients in each group).

Length of study: Screening period: 3 days; treatment period: 13 weeks.

Duration of study: 30 months after first patient randomized, including an recruitment period of 26 months.

Investigational treated regimen:Dexamethasone 10mg, iv, once day for 5 days.

Concomitant and Comparative regimen: Lamivudine 100mg po daily, traditional supporting treatments.

Assessments of Efficacy Primary endpoint: the survival rate at week 13. Secondary endpoint:①The levels of serum T-Bil ≤ 51.3µmol/L;②PTA >80%.

Safety: Adverse events, vital signs, and laboratory tests.

Procedures(summary): After signing informed consent and meeting screening parameters, patients will be randomized to one of the two treatment groups as described under trial design above. After randomization patients will be seen for evaluation at days 5,10,14,21,28,42,56,70,84,91.

Statistical analysis: Assume 1:1 randomization. The sample size is calculated for the primary efficacy variable, the survival rate. Assuming the survival rate equals to: 90% for group A and 50% for group B. 100 patients in each group are required to yield a 80% chance of detecting such a difference when a two-tailed test is employed at the 0.05 significance levels. Every eligible subject will be assigned with a randomization code and receive one of the two treatments, according to the sequence of enrolled.

Condition Intervention
Liver Failure
Hepatitis B
Drug: 5 days dexamethasone therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Study Evaluating the Efficacy and Safety of Glucocorticoids in Patients With Pre-ACLF-HBV

Resource links provided by NLM:

Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • Evidence of improving the survival rate of pre-ACLF-HBV by short-term glucocorticoids therapy [ Time Frame: within 13 weeks after treatment ]

Secondary Outcome Measures:
  • Evidence of improving liver function of pre-ACLF-HBV [ Time Frame: within 4 weeks ]

Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
glucocorticoids treatment Drug: 5 days dexamethasone therapy
dexamethasone 10mg, intravenously, po daily for the first 5 days
Other Names:
  • lamivudine
  • Transfusion of magnesium isoglycyrrhizinate injection
  • reduced glutathione
  • S-adenosyl-L- metionine

  Show Detailed Description


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female patients ≥18 and ≤ 65 years of age;
  • serum hepatitis B surface antigen (HBsAg) being positive for at least 12 months;
  • serum HBV DNA ≥104copies/ml, and did not receive any antiviral treatment with interferon or NA within 12 months;
  • serum T-Bil≥171µmol/L;
  • PTA>40%;
  • serum ALT≥10×ULN in two weeks and >5×ULN at the initiation of treatment.

Exclusion Criteria:

  • superinfection or coinfection with HAV, HCV, HDV,HEV, CMV, HIV, EBV;
  • other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease, and autoimmune hepatitis;
  • ascites determined by abdominal ultrasound scan;
  • gastrointestinal bleeding or peptic ulcer or oesophageal varix;
  • cirrhosis by abdominal ultrasound scan;
  • bacterial or fungal infections;
  • the malignant jaundice induced by obstructive or hemolytic jaundice;
  • a history of diabetes or cardiac disease or hypertension or nephrosis.
  • Inability or unwillingness to provide informed consent or abide the the requirements of the study.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01344174

Contact: Xuqing Zhang, Prof. 862368765219
Contact: Qing Mao, Prof. 862368754141

China, Chongqing
Department of infectious disease, Southwest Hospital, Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400038
Contact: Xuqing Zhang, Prof.    862368765219   
Contact: Qing Mao, Prof.    862368754141   
Principal Investigator: Xuqing Zhang, Prof.         
Sponsors and Collaborators
Third Military Medical University
Principal Investigator: Xuqing Zhang, Prof. Southwest Hospital, Third Military Medical University of China
  More Information

Responsible Party: Xuqing Zhang, Department of infectious diseases, Southwest Hospital Identifier: NCT01344174     History of Changes
Other Study ID Numbers: preACLF2011
Study First Received: April 21, 2011
Last Updated: June 2, 2011

Keywords provided by Third Military Medical University:
Acute-on-chronic liver failure

Additional relevant MeSH terms:
Hepatitis B
Liver Failure
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Hepatic Insufficiency
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017