Trial Outcomes & Findings for A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B (NCT NCT00436163)

Last Updated: 2016-10-24

Results Overview

HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (\>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels \< 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

39 participants

Primary outcome timeframe

Week 72

Results posted on

2016-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	Peginterferon Alfa-2a Participants received peginterferon alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously once per week for 48 weeks.
Overall Study STARTED	39
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Peginterferon Alfa-2a Participants received peginterferon alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously once per week for 48 weeks.
Overall Study Lost to Follow-up	2
Overall Study Adverse Event	1

Baseline Characteristics

A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peginterferon Alfa-2a n=39 Participants Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
Age, Continuous	36.28 years STANDARD_DEVIATION 13.141 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 72

Population: All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg positive at baseline.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a n=22 Participants Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)	6 participants

PRIMARY outcome

Timeframe: Week 72

Population: All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg negative at baseline.

HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA \>10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA \<10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a n=17 Participants Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL	6 participants

SECONDARY outcome

Timeframe: Week 72

Population: All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.