Clinical trial NCT00614471: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.
Official title: A Randomized, Open Label Study of the Effect of Peginterferon Alfa-2a (40KD) (PEGASYS®) Plus Entecavir (Baraclude®) Combination Therapy on Quantitative Changes in HBeAg in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 219
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 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms s.c./week for 48 weeks, 2)PEGASYS 180 micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36 or 3) entecavir 0.5mg p.o. once daily for 24 weeks + PEGASYS 180 micrograms s.c./week from week 21 to 68. Treatment will be followed by 24 weeks treatment-free follow up. The anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for group 3, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-65 years of age;
* HBsAg positive, HBeAg positive and anti-HBe negative for at least 6 months, anti-HBs negative;
* absence of cirrhosis confirmed by liver biopsy in previous 12 months.

Exclusion Criteria:

* previous treatment for chronic hepatitis B within previous 6 months;
* antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months;
* co-infection with active hepatitis A, hepatitis C, hepatitis D or HIV;
* history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis.

Primary outcomes:
measure: Log change in quantitative HBeAg from baseline to 24 weeks after end of treatment.
timeFrame: Week 72 for Arms 1 and 2. Week 92 for Arm 3.
Secondary outcomes:
measure: HBeAg seroconversion, HBV-DNA <1000 copies/mL, loss of HBeAg, HBV DNA reduction, ALT normalization, loss of HBsAg seroconversion, reduction of HBsAg 24 weeks after end of treatment.
timeFrame: Week 72 for Arms 1 and 2. Week 92 for Arm 3.
measure: AEs, laboratory parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Beijing
country: China
city: Hangzhou
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Xi'an
country: China
city: Zhengzhou
country: China
city: Hong Kong
country: Hong Kong
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Xie Q, Zhou H, Bai X, Wu S, Chen JJ, Sheng J, Xie Y, Chen C, Chan HL, Zhao M. A randomized, open-label clinical study of combined pegylated interferon Alfa-2a (40KD) and entecavir treatment for hepatitis B "e" antigen-positive chronic hepatitis B. Clin Infect Dis. 2014 Dec 15;59(12):1714-23. doi: 10.1093/cid/ciu702. Epub 2014 Sep 4.