An interventional study of 5 days dexamethasone therapy in Liver Failure and Hepatitis B, sponsored by Third Military Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-06-03.
Sponsored by Third Military Medical University · Not applicable, Interventional, and Treatment
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.
Synopsis of Protocol
Protocol of number: preACLF2011 Title: 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)10mg dexamethasone 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)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: Short-term glucocorticoids treatment (10mg dexamethasone, iv, once day for the first 5 days).
Concomitant and comparative regimen treatments: Lamivudine 100mg po daily, traditional supporting treatments including: ①Transfusion of magnesium glycyrrhizinate injection (200mg, 1/d) and reduced glutathione (1200mg, 1/d); ②S-adenosyl-L- methionine (500 mg, intravenously, 2/d); ③Transfusion of human albumin (10 g, twice a week) and fresh frozen plasma (200 ml, twice a week); ④Nutritional supplements and prophylactic therapies for various complications being given.
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.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Third Military Medical University is the lead sponsor of 81 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: 5 days dexamethasone therapy
dexamethasone 10mg, intravenously, po daily for the first 5 days
Also known as: lamivudine, Transfusion of magnesium isoglycyrrhizinate injection, reduced glutathione, S-adenosyl-L- metionine
Evidence of improving the survival rate of pre-ACLF-HBV by short-term glucocorticoids therapy
Time frame: within 13 weeks after treatment
Evidence of improving liver function of pre-ACLF-HBV
Time frame: within 4 weeks
This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Third Military Medical University