Liver FailurepreACLFNCT01344174
A Study Evaluating the Efficacy of Glucocorticoids in Patients With Pre-ACLF-HBV
A study testing 5 days dexamethasone therapy in people with Liver Failure and Hepatitis B, run by Third Military Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Failure, Hepatitis B
- What is being tested?
- 5 days dexamethasone therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of infectious disease, Southwest Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400038
Xuqing Zhang, Prof., 862368765219, xuqing651005@tom.com
Qing Mao, Prof., 862368754141, qingmao@tmmu.rdu.cn
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Liver Failure, Hepatitis B
- Being tested
- 5 days dexamethasone therapy
- Keywords
- Acute-on-chronic liver failure, HBV, Dexamethasone, Prognosis
- Medical subject headings
- Liver Failure, Hepatitis B, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 days dexamethasone therapyDrug
Also called lamivudine, Transfusion of magnesium isoglycyrrhizinate injection, reduced glutathione, S-adenosyl-L- metionine
dexamethasone 10mg, intravenously, po daily for the first 5 days
| Study group | Role | What they receive |
|---|---|---|
| glucocorticoids treatment | Other | Not described Receives: Drug: 5 days dexamethasone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of improving the survival rate of pre-ACLF-HBV by short-term glucocorticoids therapy
Measured: within 13 weeks after treatment
Secondary outcomes (1)
Evidence of improving liver function of pre-ACLF-HBV
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2011 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Xuqing Zhang, Prof., Principal investigator, Southwest Hospital, Third Military Medical University of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344174
- Sponsor's protocol ID
- preACLF2011
- Acronym
- preACLF
- Status last verified
- Jun 2011
- First submitted
- 21 Apr 2011
- Last updated
- 3 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Study Evaluating the Efficacy and Safety of Glucocorticoids in Patients With Pre-ACLF-HBV
- ClinicalTrials.gov ID
- NCT01344174
- Acronym / sponsor ID
- preACLF / preACLF2011
- Conditions
- Liver Failure, Hepatitis B
- Keywords
- Acute-on-chronic liver failure, HBV, Dexamethasone, Prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| glucocorticoids treatment | Other | Drug: 5 days dexamethasone therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 days dexamethasone therapyAlso: lamivudine, Transfusion of magnesium isoglycyrrhizinate injection, reduced glutathione, S-adenosyl-L- metioninedexamethasone 10mg, intravenously, po daily for the first 5 days | Drug | glucocorticoids treatment |
Primary outcome
Evidence of improving the survival rate of pre-ACLF-HBV by short-term glucocorticoids therapy
Time frame: within 13 weeks after treatment
1 secondary outcome
Evidence of improving liver function of pre-ACLF-HBV
Time frame: within 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuqing Zhang, Prof. principal investigator
Southwest Hospital, Third Military Medical University of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 days dexamethasone therapy in people with Liver Failure and Hepatitis B, run by Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuqing Zhang, Prof. (862368765219, xuqing651005@tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of improving the survival rate of pre-ACLF-HBV by short-term glucocorticoids therapy (time frame: within 13 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2011.