Optimized Treatment of Peginterferon Alfa 2a in Treatment Experienced Patients With HBV Related Liver Fibrosis
An Open, Multi-center Clinical Study of Combination Therapy With Tenofovir Disoproxil Fumarate and Peginterferon Alpha 2a in Nucleos(t)Ide Analogs Experienced Patients With HBV Related Hepatic Fibrosis.
1 other identifier
interventional
186
1 country
1
Brief Summary
Compared to TDF, peginterferon alfa 2a may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.
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 2019
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
May 19, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedStudy Start
First participant enrolled
November 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2023
CompletedJanuary 22, 2020
January 1, 2020
1.7 years
May 19, 2019
January 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ratio of regression of fibrosis
Regression of fibrosis was defined as liver stiffness measured by transient elastography changed from 9\~12kpa to 6\~9kpa or below, and from 6\~9kpa to less than 6kpa. After treatment, the proportion of patients with regression of fibrosis in the two groups was the ratio of regression of fibrosis, separately.
48 weeks; 96 weeks
Secondary Outcomes (3)
Ratio of loss of hepatitis b e antigen or/and seroconversion
24 week, 48 week, 72 week, 96 week
Ratio of loss of hepatitis b s antigen or/and seroconversion
24 week, 48 week, 72 week, 96 week
Logarithmic mean of HBsAg decline
24 week, 48 week, 72 week, 96 week
Study Arms (2)
TDF group
ACTIVE COMPARATOR93 patients would receive treatment of oral medication of tenofovir disoproxil fumarate (TDF) 300mg once per day from baseline to 48 weeks. Then they would receive oral medication of TDF 300 mg once per day from 49 to 96 weeks.
Combination group
ACTIVE COMPARATOR93 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg once per week and meanwhile oral medication of tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 48 weeks. Then they would receive oral medication of TDF 300 mg once per day from 49 to 96 weeks.
Interventions
Oral medication of Tenofovir Disoproxil Fumarate 300mg once per day.
Subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
Eligibility Criteria
You may qualify if:
- Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
- Receiving treatment of nucleoside/nucleotide analogues at least one year before recruited;
- Age from 18 to 55 years old;
- Normal liver function(ALT\<ULN,AST\<ULN and TBil\<ULN).
- Undetectable hepatitis b virus DNA or less than 100IU/ml.
- LSM between 6 and 12 kpa measured by fibroscan;
- Liver ultrasound: normal or echo thickening, and portal vein diameter ≤ 12mm.
You may not qualify if:
- Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;
- Pregnancy, lactation or female has plan of pregnancy within 18 months;
- Accompanied with other active liver diseases(HAV, HCV, HDV, HEV, autoimmune liver disease, drug-induced liver injury, alcoholic liver disease, genetic metabolic liver disease, etc.)；
- Accompanied with human immunodeficiency virus infection or congenital immune deficiency diseases;
- Accompanied with severe diabetes, autoimmune diseases etc. and other important organ dysfunctions;
- Patients who fail to comply with this research arrangement and sign an informed consent form
- Patients can not follow-up;
- Investigator considering inappropriate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peng, ph.D.
Third Affiliated Hospital, Sun Yat-Sen University
- STUDY DIRECTOR
Xu, ph.D.
Third Affiliated Hospital, Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 19, 2019
First Posted
May 21, 2019
Study Start
November 6, 2019
Primary Completion
July 30, 2021
Study Completion
July 30, 2023
Last Updated
January 22, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share