An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B
- Conditions
- Hepatitis B, Chronic
- Interventions
- Drug: Pegylated Interferon Alfa (Peginterferon Alfa)
- Registration Number
- NCT01730508
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multicenter, prospective, observational study will evaluate the use in clinical practice and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese participants with HBeAg negative chronic hepatitis B. Participants receiving Pegasys according to the local label will be followed for the duration of their treatment and for one year after cessation of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 978
- Adult participants, >/= 18 years of age
- Treatment with Pegasys according to label and standard clinical practice
- HBeAg negative serologically proven chronic hepatitis B with or without cirrhosis
- Serum alanine aminotransferase (ALT) > upper limit of normal (ULN) but </= 10 x ULN
- Hepatitis B Virus (HBV) DNA >/= 2000 IU/mL
- Contraindications to Pegasys as detailed in the label
- Co-infection with hepatitis A, hepatitis C or HIV
- Pregnant or lactating women
- Participants should not receive concomitant therapy with telbivudine
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic Hepatitis B Participants Pegylated Interferon Alfa (Peginterferon Alfa) Hepatitis B e antigen (HBeAg) chronic hepatitis B (CHB) participants who received treatment with pegylated interferon alfa (peginterferon alfa) according to China labeling and China standard of care and were followed up to 1 year after treatment cessation.
- Primary Outcome Measures
Name Time Method Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation approximately 4 years
- Secondary Outcome Measures
Name Time Method Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment approximately 4 years Incidence of normalization of serum ALT levels approximately 4 years Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatment approximately 4 years Incidence of HBsAg loss/seroconversion approximately 4 years Dosage/schedule of Pegasys treatment in real-life clinical setting approximately 4 years Clinical/demographic patient characteristics at initiation of treatment approximately 4 years Safety: Incidence of adverse events approximately 4 years
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (88)
The Fifth Hospital of Shijiazhuang
🇨🇳Baoding, China
Beijing Ditan Hospital
🇨🇳Beijing, China
Beijing 302 Hospital; No. 2 Infectious Disease Section
🇨🇳Beijing, China
Beijing Friendship Hospital
🇨🇳Beijing, China
Beijing You An Hospital; Digestive Dept
🇨🇳Beijing, China
Peking University Third Hospital
🇨🇳Beijing, China
Beijing Union Hospital
🇨🇳Beijing, China
the First Hospital of Jilin University
🇨🇳Changchun, China
Jilin Hepatobiliary Hospital
🇨🇳Changchun, China
Peoples Hospital of Hunan Province
🇨🇳Changsha, China
Scroll for more (78 remaining)The Fifth Hospital of Shijiazhuang🇨🇳Baoding, China