The Curative Effect of Entecavir Combined Resveratrol on HBV patients-a Multi-center, Random, Open Clinical Trial
The Curative Effect and Security of Entecavir Combined Thymosin or Resveratrol on HBeAg Positive Chronic Hepatitis B Patients - a Multi-center, Random, Control, Open Clinical Trial
1 other identifier
interventional
312
0 countries
N/A
Brief Summary
The purpose of this study is to use entecavir combined with other drug such as resveratrol and thymosin to treat patients with hepatitis B, which may provide a novel therapy target hepatitis B.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedApril 26, 2018
April 1, 2018
3.1 years
May 2, 2017
April 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HBeAg seroconversion rate
HBeAg seroconversion rate
48 weeks
Secondary Outcomes (3)
HBsAg loss rate, decline and seroconversion rate
48 weeks
HBeAg seroconversion rate and loss rate
72 weeks
cccDNA decline level
48 weeks
Study Arms (3)
entecavir
EXPERIMENTALdrug:entecavir 0.5mg/day, one time/day,144weeks
entecavir+resveratrol
EXPERIMENTALentecavir 0.5mg/day, 144weeks intervention:resveratrol 1000mg/day, 48weeks
entecavir+thymosin α1
EXPERIMENTALentecavir 0.5mg/day, 144weeks thymosin α1 2 times/week, 24weeks
Interventions
Eligibility Criteria
You may qualify if:
- Serologic evidence of chronic hepatitis B infection more than 6 months- HBeAg positive and HBeAb negative；
- HBV DNA≥20000 IU/ml (equals to 105 copy/ml)；
- ×ULN ≤ALT≤10×ULN，TBIL\<2×ULN
You may not qualify if:
- Has history of decompensated liver diseases
- Has been treated with other anti-virus drugs, or anti-tumor drugs, immuno-suppression drugs
- Has a history of autoimmune hepatitis
- History of a severe seizure disorder or current anticonvulsant use
- History or other evidence of a medical condition associated with chronic liver disease other than HBV which would make the patient, in the opinion of the investigator, unsuitable for the study (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Junqi Niu, PHD
The First Hospital of Jilin University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 2, 2017
First Posted
April 26, 2018
Study Start
November 1, 2014
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
April 26, 2018
Record last verified: 2018-04