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An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B

Completed
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
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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
GroupInterventionDescription
Chronic Hepatitis B ParticipantsPegylated 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
NameTimeMethod
Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessationapproximately 4 years
Secondary Outcome Measures
NameTimeMethod
Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatmentapproximately 4 years
Incidence of normalization of serum ALT levelsapproximately 4 years
Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatmentapproximately 4 years
Incidence of HBsAg loss/seroconversionapproximately 4 years
Dosage/schedule of Pegasys treatment in real-life clinical settingapproximately 4 years
Clinical/demographic patient characteristics at initiation of treatmentapproximately 4 years
Safety: Incidence of adverse eventsapproximately 4 years

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

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The Fifth Hospital of Shijiazhuang
🇨🇳Baoding, China
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