Completed

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)

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What is being collected

Biological Data

Collected from today forward - Prospective
Biological
Who is being recruted

Blood-Borne Infections+14

+ Chronic Disease

+ Communicable Diseases

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2011
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: April 10, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: July 8, 2011

Actual date on which the first participant was enrolled.

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.

NCT01667432
Principal SponsorHoffmann-La Roche
Last updated: April 10, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

141 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsHepatitisHepatitis BHepatitis, ChronicHepatitis, Viral, HumanInfectionsLiver DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVirus DiseasesHepadnaviridae InfectionsDisease AttributesHepatitis B, Chronic

Criteria

3 inclusion criteria required to participate
Adult patients >= 18 years of age
Elevated alanine aminotransferase (ALT) > upper limit of normal (ULN) but <= 10 x ULN according to local label
Hepatitis B envelope antigen (HBeAg) positive or HBeAg negative hepatitis B with or without cirrhosis
4 exclusion criteria prevent from participating
Co-infection with hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)
Concomitant treatment with telbivudine
Contraindications to peginterferon alfa-2a (PEGASYS) as detailed in the label
Pregnant or lactating women

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Mhat - Pleven; Clinic of Gastroenterology

Pleven, BulgariaOpen Mhat - Pleven; Clinic of Gastroenterology in Google Maps

Umhat St. Georgi; Clinical of Gastroenterology

Plovdiv, Bulgaria

MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases

Sofia, Bulgaria

UMHAT Alexandrovska EAD; Gastroenterology

Sofia, Bulgaria
Completed9 Study Centers