A Study Evaluating the Efficacy of Glucocorticoids in Patients With Pre-ACLF-HBV
Status:
Unknown status
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
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.