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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086085
• Other study ID #: ML22266
• Status: Completed
• Phase: Phase 4
• First received: March 11, 2010
• Last updated: November 1, 2016
• Start date: April 2010
• Est. completion date: March 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Major Science and Technology Special Project of China Eleventh Five-year

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)		Weeks 72, 96, 120	No
Secondary	Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml		Weeks 24, 48, 72, 96, 120	No
Secondary	Safety: Adverse Events		From baseline to Week 120	No