A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B
A Study on Optimizing HBeAg Seroconversion in HBeAg Positive CHB Patients With Combination or Sequential Treatment of Pegylated Interferon Alpha-2a and Entecavir
1 other identifier
interventional
200
1 country
7
Brief Summary
This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2009
Typical duration for phase_4
7 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
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
July 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
February 22, 2016
CompletedMarch 25, 2016
February 1, 2016
2.7 years
June 16, 2009
January 24, 2016
February 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48
Hepatitis B envelope Antigen (HBeAg) seroconversion was defined as the absence of HBeAg and the presence of antibody to Hepatitis B envelope antigen (anti-HBe).
At Week 48
Secondary Outcomes (9)
Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48
At Week 48
Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48
At Week 48
Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48
At Week 48
Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48
At Week 48
Percentage of Participants With Normalized Alanine Aminotransferase at Week 48
At Week 48
- +4 more secondary outcomes
Study Arms (2)
Peginterferon alfa-2a + entecavir
EXPERIMENTALParticipants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks.
Entecavir
ACTIVE COMPARATORParticipants received entecavir 0.5 mg orally once daily for 48 weeks.
Interventions
180 micrograms sc/week for 48 weeks
Eligibility Criteria
You may qualify if:
- Adult patients, \>=18 and \</= 65 years of age
- HBeAg positive chronic hepatitis B
- Pre-treatment with entecavir for 9-36 months
You may not qualify if:
- Antiviral, antineoplastic or immunomodulatory treatment
- Co-infection with active hepatitis A, C or D, or HIV
- Evidence of decompensated liver disease
- History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Changsha, 410008, China
Unknown Facility
Chengdu, 610041, China
Unknown Facility
Fuzhou, 350005, China
Unknown Facility
Guangzhou, 510515, China
Unknown Facility
Hangzhou, 310003, China
Unknown Facility
Wuhan, 430030, China
Unknown Facility
Xi'an, 710038, China
Related Publications (2)
Yan W, Wu D, Wang X, Chen T, Lai Q, Zheng Q, Jiang J, Hou J, Han M, Ning Q. Upregulation of NKG2C+ natural killer cells, TLR-2 expression on monocytes and downregulation of regulatory T-cells influence PEG-IFN treatment efficacy in entecavir-suppressed patients with CHB. Antivir Ther. 2015;20(6):591-602. doi: 10.3851/IMP2953. Epub 2015 Mar 27.
PMID: 25814467DERIVEDNing Q, Han M, Sun Y, Jiang J, Tan D, Hou J, Tang H, Sheng J, Zhao M. Switching from entecavir to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: a randomised open-label trial (OSST trial). J Hepatol. 2014 Oct;61(4):777-84. doi: 10.1016/j.jhep.2014.05.044. Epub 2014 Jun 7.
PMID: 24915612DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2009
First Posted
July 16, 2009
Study Start
April 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 25, 2016
Results First Posted
February 22, 2016
Record last verified: 2016-02