A Study Evaluating the Efficacy of Glucocorticoids in Patients With Pre-ACLF-HBV (preACLF)
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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|
- Evidence of improving the survival rate of pre-ACLF-HBV by short-term glucocorticoids therapy [ Time Frame: within 13 weeks after treatment ] [ Designated as safety issue: Yes ]
- Evidence of improving liver function of pre-ACLF-HBV [ Time Frame: within 4 weeks ] [ Designated as safety issue: Yes ]
|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)|
Drug: 5 days dexamethasone therapy
dexamethasone 10mg, intravenously, po daily for the first 5 days
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01344174
|Department of infectious disease, Southwest Hospital, Third Military Medical University|
|Chongqing, Chongqing, China, 400038|
|Principal Investigator:||Xuqing Zhang, Prof.||Southwest Hospital, Third Military Medical University of China|