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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: March 10, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Hepatitis B, Chronic Biological: Peginterferon alfa-2a

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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).

  • Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml [ Time Frame: approximately 3 years ]
  • In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive [ Time Frame: approximately 3 years ]

Secondary Outcome Measures:
  • 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.

  • HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative [ Time Frame: approximately 3 years ]
  • Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients [ Time Frame: approximately 3 years ]
  • Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients [ Time Frame: approximately 3 years ]
  • Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio [ Time Frame: approximately 3 years ]
  • Safety: Incidence of Adverse Events [ Time Frame: approximately 3 years ]

Enrollment: 141
Actual Study Start Date: July 8, 2011
Study Completion Date: August 12, 2014
Primary Completion Date: August 12, 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Peginterferon alfa-2a
Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
Biological: Peginterferon alfa-2a
Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.
Other Names:
  • PEGASYS®
  • RO0258310

  Eligibility

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
Patients with chronic hepatitis B on treatment with PEGASYS.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667432

Locations
Bulgaria
Mhat - Pleven; Clinic of Gastroenterology
Pleven, Bulgaria, 5800
Umhat St. Georgi; Clinical of Gastroenterology
Plovdiv, Bulgaria, 4002
MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
Sofia, Bulgaria, 1407
UMHAT Alexandrovska EAD; Gastroenterology
Sofia, Bulgaria, 1431
Mhat Queenjoanna; Clinic of Gastroenterology
Sofia, Bulgaria, 1527
Military Medical Academy; Gastroenterology
Sofia, Bulgaria, 1606
Mhat St. Ivan Rilski; Clinic of Gastroenterology
Sofia, Bulgaria, 1612
Mhat St. Zagora; Clinical of Gastroenterology
Stara Zagora, Bulgaria, 6000
Mhat Sveta Marina; Clinic of Gastroenterology
Varna, Bulgaria, 9010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01667432     History of Changes
Other Study ID Numbers: ML25626
Study First Received: August 15, 2012
Results First Received: October 1, 2015
Last Updated: March 10, 2017

Additional relevant MeSH terms:
Hepatitis
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
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2017