Clinical trial NCT01667432: An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-17
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis B on treatment with PEGASYS.

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study
timeFrame: At the end of the study (Week 36)
measure: Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml
timeFrame: approximately 3 years
measure: In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive
timeFrame: approximately 3 years
Secondary outcomes:
measure: Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment
timeFrame: At the end of treatment (Week 24)
measure: HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative
timeFrame: approximately 3 years
measure: Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients
timeFrame: approximately 3 years
measure: Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients
timeFrame: approximately 3 years
measure: Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio
timeFrame: approximately 3 years
measure: Safety: Incidence of Adverse Events
timeFrame: approximately 3 years
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Mhat - Pleven; Clinic of Gastroenterology
city: Plovdiv
country: Bulgaria
facility: Umhat St. Georgi; Clinical of Gastroenterology
city: Sofia
country: Bulgaria
facility: MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
city: Sofia
country: Bulgaria
facility: UMHAT Alexandrovska EAD; Gastroenterology
city: Sofia
country: Bulgaria
facility: Mhat Queenjoanna; Clinic of Gastroenterology
city: Sofia
country: Bulgaria
facility: Military Medical Academy; Gastroenterology
city: Sofia
country: Bulgaria
facility: Mhat St. Ivan Rilski; Clinic of Gastroenterology
city: Stara Zagora
country: Bulgaria
facility: Mhat St. Zagora; Clinical of Gastroenterology
city: Varna
country: Bulgaria
facility: Mhat Sveta Marina; Clinic of Gastroenterology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: