A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: peginterferon alfa-2a [Pegasys]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00435825

WV19432

Details and patient eligibility

About

This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Enrollment: 551 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• positive Hepatitis B surface antigen (HBsAg) for >6 months, positive HBeAg, HBV DNA >500,000 copies/mL, and anti-HBs negative;
• liver disease consistent with Chronic Hepatitis B.

Exclusion criteria

• antiviral therapy for CHB within previous 6 months;
• co-infection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus (HDV) or Human immuno deficiency virus (HIV);
• evidence of decompensated liver disease;
• medical condition associated with chronic liver disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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551 participants in 4 patient groups

peginterferon alfa-2a 90 μg_24 Weeks

Experimental group

Description:

Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

peginterferon alfa-2a 180 μg_24 Weeks

Experimental group

Description:

Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

peginterferon alfa-2a 90 μg_48 Weeks

Experimental group

Description:

Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

peginterferon alfa-2a 180 μg_48 Weeks

Experimental group

Description:

Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.

Treatment:

Drug: peginterferon alfa-2a [Pegasys]