A Study Evaluating the Efficacy of Glucocorticoids in Patients With Pre-ACLF-HBV
preACLF
A Randomized, Open Label Study Evaluating the Efficacy and Safety of Glucocorticoids in Patients With Pre-ACLF-HBV
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2011
CompletedFirst Posted
Study publicly available on registry
April 28, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJune 3, 2011
June 1, 2011
3 months
April 21, 2011
June 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evidence of improving the survival rate of pre-ACLF-HBV by short-term glucocorticoids therapy
within 13 weeks after treatment
Secondary Outcomes (1)
Evidence of improving liver function of pre-ACLF-HBV
within 4 weeks
Study Arms (1)
glucocorticoids treatment
OTHERInterventions
dexamethasone 10mg, intravenously, po daily for the first 5 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of infectious disease, Southwest Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400038, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xuqing Zhang, Prof.
Southwest Hospital, Third Military Medical University of China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 21, 2011
First Posted
April 28, 2011
Study Start
May 1, 2011
Primary Completion
August 1, 2011
Study Completion
November 1, 2013
Last Updated
June 3, 2011
Record last verified: 2011-06