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

Hoffmann-La Roche551 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

551

Conditions

Hepatitis B, Chronic

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (55)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Palo Alto, California, United States

Unnamed facility

San Diego, California, United States

Unnamed facility

San Francisco, California, United States

Unnamed facility

San Jose, California, United States

Unnamed facility

Outcomes

Primary Outcomes

Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment

Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe) determined at 24 weeks after the end of treatment.

Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

Secondary Outcomes

Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72

Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBs) determined at Week 72.

Time frame: Week 72

Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment

Blood was collected HBeAg 24 Weeks following the end of treatment. Loss of HBeAg is defined as the absence of HBeAg.

Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment

HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs) determined at 24 weeks after the end of treatment.

Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment

Blood was collected for HBsAg 24 weeks following the end of treatment. Loss of HBsAg is defined as the absence of HBsAg.

Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

Percentage of Participants With Normal Alanine Aminotransferase (ALT)

Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay.

Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment

Blood was collected for HBV-DNA 24 weeks following the end of treatment and was analyzed at the central laboratory using the Roche approved polymerase chain reaction (PCR) methodology. Percentage of participants with a HBV-DNA suppression of \< 20,000 IU/mL (Less than 100,000 copies/mL) is reported.

Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment

Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. Percentage of participants with A HBV-DNA Suppression of \< 2,000 IU/mL (Less than 10,000 copies/mL) is reported.

Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment)

Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment

Combined endpoint was defined as HBeAg seroconversion, a normal serum ALT and HBV-DNA suppression below 20,000 IU/mL.

Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment

Dual endpoint was defined as the achievement of both HBeAg seroconversion and a HBV-DNA \<2,000 IU/ml (Less than 10,000 copies/mL).

Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment

Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay: 0- 55 units/liter (U/L).

Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

Quantitative HBV-DNA 24 Weeks Following End of Treatment

Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment.

Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)