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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Third Military Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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