Clinical trial NCT00940485: A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B
Official title: A Study on Optimizing HBeAg Seroconversion in HBeAg Positive CHB Patients With Combination or Sequential Treatment of Pegylated Interferon Alpha-2a and Entecavir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-07-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>=18 and \</= 65 years of age
* HBeAg positive chronic hepatitis B
* Pre-treatment with entecavir for 9-36 months

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48
timeFrame: At Week 48
Secondary outcomes:
measure: Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48
timeFrame: At Week 48
measure: Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48
timeFrame: At Week 48
measure: Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48
timeFrame: At Week 48
measure: Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48
timeFrame: At Week 48
measure: Percentage of Participants With Normalized Alanine Aminotransferase at Week 48
timeFrame: At Week 48
measure: Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time
timeFrame: Up to Week 48
measure: Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time
timeFrame: Up to Week 48
measure: Number of Participants With Incidence of Adverse Events and Serious Adverse Events
timeFrame: Up to Week 48
measure: Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event
timeFrame: Up to Week 48
Other outcomes:
Locations:
city: Changsha
country: China
city: Chengdu
country: China
city: Fu Zhou
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Wuhan
country: China
city: Xi'an
country: China
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Ning 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.