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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01730508
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : July 14, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hepatitis B, Chronic Drug: Pegylated Interferon Alfa (Peginterferon Alfa)

Study Type : Observational
Actual Enrollment : 978 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : November 20, 2012
Primary Completion Date : June 25, 2017
Study Completion Date : June 25, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Chronic Hepatitis B Participants
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.
Drug: Pegylated Interferon Alfa (Peginterferon Alfa)
Peginterferon alfa dosing and treatment duration are at the discretion of the investigator in accordance with China clinical practice and local labeling.
Other Name: Pegasys

Primary Outcome Measures :
  1. Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation [ Time Frame: approximately 4 years ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chinese participants with HBeAg negative chronic hepatitis B receiving treatment with Pegasys

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01730508

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Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01730508     History of Changes
Other Study ID Numbers: ML28516
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs