A Study Evaluating the Efficacy of Glucocorticoids in Patients With Pre-ACLF-HBV (preACLF)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Liver Failure Hepatitis B |
Drug: 5 days dexamethasone therapy |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 200 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
| glucocorticoids treatment |
Drug: 5 days dexamethasone therapy
dexamethasone 10mg, intravenously, po daily for the first 5 days
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Xuqing Zhang, Prof. | 862368765219 | xuqing651005@tom.com |
| Contact: Qing Mao, Prof. | 862368754141 | qingmao@tmmu.edu.cn |
| China, Chongqing | |
| Department of infectious disease, Southwest Hospital, Third Military Medical University | Recruiting |
| Chongqing, Chongqing, China, 400038 | |
| Contact: Xuqing Zhang, Prof. 862368765219 xuqing651005@tom.com | |
| Contact: Qing Mao, Prof. 862368754141 qingmao@tmmu.rdu.cn | |
| Principal Investigator: Xuqing Zhang, Prof. | |
| Principal Investigator: | Xuqing Zhang, Prof. | Southwest Hospital, Third Military Medical University of China |
More Information
No publications provided
| Responsible Party: | Xuqing Zhang, Department of infectious diseases, Southwest Hospital |
| ClinicalTrials.gov Identifier: | NCT01344174 History of Changes |
| Other Study ID Numbers: | preACLF2011 |
| Study First Received: | April 21, 2011 |
| Last Updated: | June 2, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Third Military Medical University:
|
Acute-on-chronic liver failure HBV Dexamethasone Prognosis |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Liver Failure Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Hepatic Insufficiency Dexamethasone acetate |
Dexamethasone Dexamethasone 21-phosphate Glucocorticoids BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013