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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01667432
First received: August 15, 2012
Last updated: November 3, 2015
Last verified: November 2015

August 15, 2012
November 3, 2015
July 2011
August 2014   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: No ]
    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).
  • Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01667432 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
    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.
  • HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients [ Time Frame: approximately 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of Adverse Events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients [ Time Frame: approximately 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of Adverse Events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B
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)
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients with chronic hepatitis B on treatment with PEGASYS.
Hepatitis B, Chronic
Biological: Peginterferon alfa-2a
Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.
Other Names:
  • PEGASYS®
  • RO0258310
Peginterferon alfa-2a
Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
Intervention: Biological: Peginterferon alfa-2a
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
August 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria
 
NCT01667432
ML25626
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP