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

Hoffmann-La Roche18 enrolled

Overview

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a [Pegasys]DRUG

180 micrograms sc weekly for 48 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients, 18-70 years of age; * chronic hepatitis B; * Hepatitis B Virus (HBV) DNA \>100,000 copies/mL. Exclusion Criteria: * previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months; * evidence of decompensated liver disease; * history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis; * coinfection with hepatitis A, C or D, or HIV.

Locations (23)

Unnamed facility

Chelyabinsk, Russia

Unnamed facility

Irkutsk, Russia

Unnamed facility

Kazan', Russia

Outcomes

Primary Outcomes

Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL

This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) \<100,000 copies/mL were reported.

Time frame: Week 96

Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL

This study included 14 HBeAg negative participants. Participants with HBV DNA \<20,000 copies/mL were reported.

Time frame: Week 96

Secondary Outcomes

Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion

Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb). Sustained HBe seroconversion is defined as loss of HBeAg and presence of hepatitis B e-antibody (HBeAb). This study included 4 HBeAg positive participants.

Time frame: Week 96

Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT

Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of HBsAb. This study included 14 HBeAg negative participants.

Time frame: Week 96

Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)

All participants who received at least one dose of the study drug were analysed. Number of participants with any adverse events and any serious adverse events are reported.

Time frame: Up to Week 96

Data from ClinicalTrials.gov

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