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

June 2, 2011 updated by: Third Military Medical University

A Randomized, Open Label Study Evaluating the Efficacy and Safety of Glucocorticoids in Patients With Pre-ACLF-HBV

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Department of infectious disease, Southwest Hospital, Third Military Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xuqing Zhang, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Evidence of improving liver function of pre-ACLF-HBV
Time Frame: within 4 weeks
within 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Investigators

  • Principal Investigator: Xuqing Zhang, Prof., Southwest Hospital, Third Military Medical University of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (Estimate)

April 28, 2011

Study Record Updates

Last Update Posted (Estimate)

June 3, 2011

Last Update Submitted That Met QC Criteria

June 2, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • preACLF2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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