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NCT Number: NCT01734018

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

This multicenter, prospective, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys according to standard of care and the summary od product characteristics/local labelling will be followed for the duration of treatment and up to 2 years of follow-up.

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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

Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, >/= 18 years of age
  • HBeAg-positive or HBeAg-negative serologically proven chronic hepatitis B with or without cirrhosis
  • Elevated serum ALT > ULN (upper limit of normal) but </=10 x ULN according to local label

Exclusion criteria

  • Contra-indications to Pegasys as detailed in the label
  • Co-infection with hepatitis A, hepatitis B or HIV
  • Concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contra-indicated according to telbivudine label)
  • Pregnant or breastfeeding women

Treatment and study plan

Primary outcomes

  1. Change in HBsAg (IU/ml) levels during therapy (up to 48 weeks) and follow-up

    Time frame: from baseline to up to approximately 3 years

  2. Change in HBV DNA (IU/ml) during therapy (up to 48 weeks) and follow-up

    Time frame: from baseline to up to approximately 3 years

Secondary outcomes

  1. Percentage of patients with sustained immune control (sustained HBV DNA <2000 IU/ml in HBeAg-negative and HBeAg-positive patients or HBeAg seroconversion in HBeAg-positive patients)

    Time frame: approximately 4 years

  2. Percentage of patients with normalisation of serum alanine transaminase (ALT) levels

    Time frame: approximately 4 years

  3. Percentage of patients with HBsAg clearance/seroconversion

    Time frame: approximately 4 years

  4. 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, Non-Interventional Study Evaluating Response Parameters During and After Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 27, 2012
Registry last updated
Nov 2, 2016

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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