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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:
Hoffmann-La Roche
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
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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:
|
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01667432
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 21, 2017