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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Third Military Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01344174
First received: April 21, 2011
Last updated: June 2, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:
  • lamivudine
  • Transfusion of magnesium isoglycyrrhizinate injection
  • reduced glutathione
  • S-adenosyl-L- metionine

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344174

Contacts
Contact: Xuqing Zhang, Prof. 862368765219 xuqing651005@tom.com
Contact: Qing Mao, Prof. 862368754141 qingmao@tmmu.edu.cn

Locations
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.         
Sponsors and Collaborators
Third Military Medical University
Investigators
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:
Glucocorticoids
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
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 July 26, 2014