A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive

NCT01086085 — Phase 4, Completed, 265 participants, Hoffmann-La Roche

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A Study on Optimizing the Treatment in HBeAg Positive CHB Patients With Response Guide Treatment (RGT) Method.

Registry	NCT01086085
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	265 (Actual)
Sponsor	Hoffmann-La Roche (Industry); collaborators: Major Science and Technology Special Project of China Eleventh Five-year
Conditions	Hepatitis B, Chronic
Interventions	Adefovir, peginterferon alfa-2a [PEGASYS] (Drug)
Dates	start 2010-04-01, primary completion 2013-03-01, completion 2013-03-01, first posted 2010-03-12, last updated 2016-11-02
Locations	11 sites in China

-Summary

This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a \[PEGASYS\] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.

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+Arms and interventions

Arm	Type	Interventions
A	Experimental	Drug: peginterferon alfa-2a [PEGASYS]
B	Experimental	Drug: peginterferon alfa-2a [PEGASYS]
C	Experimental	Drug: peginterferon alfa-2a [PEGASYS]
D	Experimental	Drug: Adefovir; Drug: peginterferon alfa-2a [PEGASYS]

Adefovir (Drug): Adefovir 10 mg po once daily for 36 weeks
peginterferon alfa-2a [PEGASYS] (Drug): Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
peginterferon alfa-2a [PEGASYS] (Drug): Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
peginterferon alfa-2a [PEGASYS] (Drug): Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks

+Outcome measures

Primary outcomes

Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction) [Weeks 72, 96, 120]

Secondary outcomes

Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml [Weeks 24, 48, 72, 96, 120]
Safety: Adverse Events [From baseline to Week 120]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* Adult patients >/=18 years of age
* HBeAg positive chronic hepatitis B
* Compensated liver disease

Exclusion Criteria:

* Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start
* Antiviral, anti-neoplastic or immunomodulatory treatment
* Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV
* Evidence of decompensated liver disease
* Chronic liver disease other than viral hepatitis

+Locations (11)

Facility	City	Country	Status
	Beijing	China
	Beijing	China
	Beijing	China
	Beijing	China
	Changchun	China
	Guangzhou	China
	Shanghai	China
	Shanghai	China
	Shanghai	China
	Wuhan	China
	Xi'an	China

+Publications

Results publication: Sun J, Ma H, Xie Q, Xie Y, Sun Y, Wang H, Shi G, Wan M, Niu J, Ning Q, Yu Y, Zhou H, Cheng J, Kang W, Xie Y, Fan R, Wei L, Zhuang H, Jia J, Hou J. Response-guided peginterferon therapy in patients with HBeAg-positive chronic hepatitis B: A randomized controlled study. J Hepatol. 2016 Oct;65(4):674-682. doi: 10.1016/j.jhep.2016.05.024. Epub 2016 May 26. PMID 27238752

+Investigators

Clinical Trials, Study director, Hoffmann-La Roche