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NCT Number: NCT01730508

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

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Fifth Hospital of Shijiazhuang, Baoding, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegylated Interferon Alfa (Peginterferon Alfa)

Drug

Peginterferon alfa dosing and treatment duration are at the discretion of the investigator in accordance with China clinical practice and local labeling.

Other names: Pegasys

Primary outcomes

  1. Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation

    Time frame: approximately 4 years

Secondary outcomes

  1. Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment

    Time frame: approximately 4 years

  2. Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatment

    Time frame: approximately 4 years

  3. Incidence of HBsAg loss/seroconversion

    Time frame: approximately 4 years

  4. Incidence of normalization of serum ALT levels

    Time frame: approximately 4 years

  5. Dosage/schedule of Pegasys treatment in real-life clinical setting

    Time frame: approximately 4 years

  6. Clinical/demographic patient characteristics at initiation of treatment

    Time frame: approximately 4 years

  7. Safety: Incidence of adverse events

    Time frame: approximately 4 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A MULTICENTER, PROSPECTIVE, OBSERVATIONAL, NON-INTERVENTIONAL COHORT STUDY IN CHINESE SUBJECTS WITH HBeAg NEGATIVE CHRONIC HEPATITIS B (CHB) RECEIVING THERAPY WITH PEGINTERFERON ALFA

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Nov 21, 2012
Registry last updated
Jul 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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