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

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Peginterferon Alfa-2a

U.S. FDA Resources

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) ] [ 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 ]

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) ] [ 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 ]


Enrollment:	141
Study Start Date:	July 2011
Study Completion Date:	August 2014
Primary Completion Date:	August 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)
Genders Eligible for Study:	Both
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

Pleven, Bulgaria, 5800

Plovdiv, Bulgaria, 4002

Sofia, Bulgaria, 1407

Sofia, Bulgaria, 1431

Sofia, Bulgaria, 1527

Sofia, Bulgaria, 1606

Sofia, Bulgaria, 1612

Stara Zagora, Bulgaria, 6000

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:	November 3, 2015
Health Authority:	Bulgaria: Bulgarian Drug Agency

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 September 30, 2016