Switch or Sequential Combination Therapy of Peginterferon in Hepatitis B Patients With Longterm Entecavir Therapy
Efficacy of Switch or Sequential Combination Therapy of Pegylated Interferon Alfa-2a in Chronic Hepatitis B Patients With Low HBsAg and HBeAg Titers After Long-term Entecavir Therapy: A Multicenter, Prospective Cohort Study
1 other identifier
observational
294
1 country
17
Brief Summary
This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 25, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedOctober 28, 2015
October 1, 2015
2 years
October 25, 2015
October 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of HBeAg seroconversion
Loss of HBeAg and detection of anti-HBe antibodies
week 72 (24 weeks after 48 weeks of treatment)
Secondary Outcomes (5)
Rate of HBsAg loss
week 72 (24 weeks after 48 weeks of treatment)
Rate of HBV DNA <20IU/mL
week 72 (24 weeks after 48 weeks of treatment)
Rate of HBsAg seroconversion
week 72 (24 weeks after 48 weeks of treatment)
Percentage of patients reaching a ≥ 1log10 decline of quantitative HBsAg
week 72 (24 weeks after 48 weeks of treatment)
Decline of quantitative HBsAg from baseline
week 72 (24 weeks after 48 weeks of treatment
Study Arms (3)
Switch group
Patients who have been assigned to pegylated interferon alfa-2a.
Sequential combination group (S-C group)
Patients who have been assigned to pegylated interferon alfa-2a plus entecavir.
ETV group
Patients who have been assigned to entecavir monotherapy.
Interventions
ETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 8 weeks and followed by PegIFN alfa-2a 180ug subcutaneous injection weekly for 40 weeks
ETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 48 weeks
Eligibility Criteria
Chronic Hepatitis B Patients with Low HBsAg and HBeAg Titers after Long-term Entecavir Therapy
You may qualify if:
- Male and female patients \> 18 and ≤ 60 years of age;
- Positive HBsAg for more than 6 months;
- Patients receiving previous ETV therapy ≥2 years;
- Patients who have achieved undetectable HBV DNA, HBsAg \<1500IU/mL and HBeAg \<200S/CO prior to switch or S-C therapy;
- ALT\<=10\*ULN and TB\<2\*ULN;
- Patients who have been assigned to treatment with PegIFN (S-C or switch) or continuous ETV after previous ETV therapy
You may not qualify if:
- Evidence of decompensated cirrhosis or hepatocellular carcinoma;
- Serological evidence of co-infection with HCV, HDV or HIV;
- Pregnant or breast-feeding women;
- Patients with diseases that might contraindicate to PegIFN therapy including severe psychiatric diseases, immunological diseases, severe retinopathy, thyroid dysfunction, leukocytopenia, thrombopenia, etc
- Patients receiving concomitant therapy with telbivudine;
- A history of drug or alcohol abuse;
- Other conditions that investigates consider not suitable for participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
Study Sites (17)
The First Affiliated Hospital, Anhui Medical University
Hefei, Anhui, China
The Second Affiliated Hospital, Anhui Medical University
Hefei, Anhui, China
Beijing Ditan Hospital
Beijing, Beijing Municipality, China
Fuzhou Municipal Infectious Disease Hospital
Fuzhou, Fujian, China
Zhongshan No.2 People's Hospital, Zhongshan, Guangdong
Guangzhou, Guangdong, China
The third People's Hospital of Shenzhen
Shenzhen, Guangdong, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
Shenyang Municipal Infectious Disease Hospital
Shenyang, Liaoning, China
Shandong Provincial Hospital of Shandong University
Jinan, Shandong, China
The First Affiliated Hospital Medical School of Xi'an Jiaotong University
Xi’an, Shanxi, China
The Affiliated Hospital of Luzhou Medical College
Luzhou, Sichuan, 646000, China
Sichuan Provincial People's Hospital
Sichuan, Sichuan, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
The Second Hospital of Yinzhou of Ningbo
Ningbo, Zhejiang, 315040, China
Rui'an People's Hospital
Rui’an, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wenhong Zhang, MD, PhD
Huashan Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Division of Infectious Diseases
Study Record Dates
First Submitted
October 25, 2015
First Posted
October 28, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
October 28, 2015
Record last verified: 2015-10