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

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ClinicalTrials.gov Identifier: NCT01667432
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : December 7, 2015
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Hepatitis B, Chronic Biological: Peginterferon alfa-2a

Study Design
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Study Type : Observational
Actual Enrollment : 141 participants
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)
Actual Study Start Date : July 8, 2011
Actual Primary Completion Date : August 12, 2014
Actual Study Completion Date : August 12, 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01667432     History of Changes
Other Study ID Numbers: ML25626
First Posted: August 17, 2012    Key Record Dates
Results First Posted: December 7, 2015
Last Update Posted: April 10, 2017
Last Verified: March 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