A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
- Conditions
- Hepatitis B, Chronic
- Interventions
- Drug: peginterferon alfa-2a [Pegasys]
- Registration Number
- NCT00487747
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- adult patients, 18-70 years of age;
- chronic hepatitis B;
- Hepatitis B Virus (HBV) DNA >100,000 copies/mL.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Peginterferon Alfa-2a peginterferon alfa-2a [Pegasys] -
- Primary Outcome Measures
Name Time Method Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL Week 96 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.
Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL Week 96 This study included 14 HBeAg negative participants. Participants with HBV DNA \<20,000 copies/mL were reported.
- Secondary Outcome Measures
Name Time Method Mean Change in Laboratory Parameters (ALT Levels) From Screening (Day 0) to Week 96 Mean Change in Laboratory parameters (ALT levels) is reported.
Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT Week 96 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.
Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) Up to Week 96 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.
Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion Week 96 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.