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NCT Number: NCT01667432

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

This prospective, multicenter, observational study will evaluate on-treatment predictors of response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the summary of product characteristics. Data will be collected from patients for the duration of their treatment and for up to 24 weeks thereafter.

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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

Mhat - Pleven; Clinic of Gastroenterology, Pleven, Bulgaria

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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 patients ≥ 18 years of age.
  • Hepatitis B envelope antigen (HBeAg) positive or HBeAg negative hepatitis B with or without cirrhosis.
  • Elevated alanine aminotransferase (ALT) > upper limit of normal (ULN) but ≤ 10 x ULN according to local label.

Exclusion criteria

  • Contraindications to peginterferon alfa-2a (PEGASYS®) as detailed in the label.
  • Co-infection with hepatitis A, hepatitis C, or human immunodeficiency virus (HIV).
  • Concomitant treatment with telbivudine.
  • Pregnant or lactating women.

Treatment and study plan

peginterferon alfa-2a

Biological

Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.

Other names: PEGASYS®, RO0258310

Primary outcomes

  1. Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study

    Time frame: At the end of the study (Week 36)

    Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).

  2. Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml

    Time frame: approximately 3 years

  3. In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive

    Time frame: approximately 3 years

Secondary outcomes

  1. Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment

    Time frame: At the end of treatment (Week 24)

    Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.

  2. HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative

    Time frame: approximately 3 years

  3. Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients

    Time frame: approximately 3 years

  4. Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients

    Time frame: approximately 3 years

  5. Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio

    Time frame: approximately 3 years

  6. Safety: Incidence of Adverse Events

    Time frame: approximately 3 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Multicenter, Prospective, Observational, Non-interventional Study Evaluating On-treatment Predictors of Response in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD)

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 17, 2012
Registry last updated
Apr 10, 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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