A Real-World Study of Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B
COST
A Real-World Study of Sequential Combination Therapy With Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B
1 other identifier
interventional
2,000
1 country
12
Brief Summary
The aim of the prospective real-world study is to evaluate whether sequential combination therapy with pegylated interferon plus entecavir/tenofovir could induce higher rates of HBsAg loss in nucleoside-treated patients with chronic hepatitis B compared to continuous nucleoside treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2018
Longer than P75 for phase_4
12 active sites
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
November 20, 2017
CompletedFirst Posted
Study publicly available on registry
November 30, 2017
CompletedStudy Start
First participant enrolled
January 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2022
CompletedApril 25, 2018
April 1, 2018
4 years
November 20, 2017
April 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HBsAg loss rate
Percentages of patients who achieve HBsAg loss at week 48
at week 48
Secondary Outcomes (25)
HBsAg loss rate
at week 72
HBsAg loss rate
at week 96
HBsAg level
at week 48
HBsAg level
at week 72
HBsAg level
at week 96
- +20 more secondary outcomes
Study Arms (2)
Sequential combination therapy group
EXPERIMENTALPatients are treated with pegylated Interferon (180ug, subcutaneously, once a week) plus entecavir (0.5mg, orally, every day) or tenofovir disoproxil fumarate (300mg, orally, every day) for 48/72/96 weeks
Nucleoside therapy group
ACTIVE COMPARATORPatients are treated with entecavir (0.5mg, orally, every day) or tenofovir disoproxil fumarate (300mg, orally, every day) for 96 weeks
Interventions
180ug Pegylated interferon is injected subcutaneously once a week
0.5mg entecavir is orally taken every day
300mg tenofovir is orally taken every day
Eligibility Criteria
You may qualify if:
- Male and female patients from 18 to 65 years of age;
- HBsAg positive, entecavir and or adefovir dipivoxil are used at least 1 year including patients with nucleotides or nucleoside resistance history;
- Before nucleotides or nucleosides treatment, ALT \> 2 upper limit of normal value (ULN), HBV DNA \>10000 copies/ml, HBsAg positive;
- Serum HBV DNA ≤ 500 copies/ml;
- HBsAg\<3000 IU/ml;
- HBsAg positive;
- Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug;
- Absence of cirrhosis confirmed by ultrasonic test;
- Agree to participate in the study and sign the patient informed consent.
You may not qualify if:
- HBV DNA \> 500 copies/ml;
- Other antiviral, anti-neoplastic or immunomodulatory treatment (including supra physiologic doses of steroids and radiation) 6 months prior to the first dose of randomized treatment (except for 7 days of acyclovir for herpetic lesions more than 1 month prior to first administration of randomized treatment). Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation are also excluded;
- Women with ongoing pregnancy or breast-feeding;
- Co-infection with active hepatitis A, hepatitis C, hepatitis D(Those hospitals which have the ability to do the test will do) and/or human immunodeficiency virus (HIV);
- ALT \>10 ULN;
- Evidence of decompensated liver disease (Child-Pugh score \> 5). Child-Pugh \> 5 means, if one of the following 5 conditions are met, the patient has to be excluded:
- one of the following 5 conditions are met, the patient has to be excluded:
- Serum albumin \< 3.5 g/L;
- Prothrombin time \> 3 seconds prolonged;
- Serum bilirubin \> 34 µ mol/L;
- History of encephalopathy;
- History of variceal bleeding;
- Ascites;
- History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
- Signs or symptoms of hepatocellular carcinoma, patients with a value of alpha-fetoprotein \> 100 ng/mL are excluded, unless stability (less than 10% increase) has been documented over at least the previous 3 months. Patients with values \< 20 ng/mL but \> 100 ng/mL may be enrolled, if hepatic neoplasia has been excluded by liver imaging;
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Study Sites (12)
302 Military Hospital of China
Beijing, Beijing Municipality, China
BeiJing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Hospital Affiliated to AMU
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Zhejiang, Hangzhou, Doctor, China
Departmen of infectious disease, Xiangya Hospital, Central-south Universit
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
Traditional Chinese Medicine,Xiamen Hospital
Shantou, Xiamen, China
The first affiliated hospital of Wenzhou medical universtiy
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qin Ning
Department of Infectious Diseases, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
November 20, 2017
First Posted
November 30, 2017
Study Start
January 25, 2018
Primary Completion
January 25, 2022
Study Completion
July 25, 2022
Last Updated
April 25, 2018
Record last verified: 2018-04