An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam

A Multicenter, Prospective, Observational, Non-Interventional Cohort Study Evaluating Sustained Response in Subjects With HBeAg Positive Chronic Hepatitis B Receiving Therapy With Pegasys (Peginterferon Alfa-2a) in Vietnam

This prospective, multicenter, observational study will evaluate the sustained response in patients with HBeAg positive chronic hepatitis B who are treated with Pegasys according to standard of care and in line with the current local labeling in routine clinical practice in Vietnam. Eligible patients will be followed for the duration of their treatment and for up to 2 years thereafter.

Study Overview

• Status: Terminated
• Conditions: Hepatitis B, Chronic

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
  • Ho Chi Minh City, Vietnam, District 5
  • Hochiminh city, Vietnam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with HBeAg-positive chronic hepatitis B treated with Pegasys

Description

Inclusion Criteria:

• Adult patients, >/= 18 years of age
• HBeAg-positive serologically proven chronic hepatitis B with or without cirrhosis
• Elevated serum ALT > ULN (upper limit of normal) but </= 10 x ULN
• Patients with no contra-indications to Pegasys therapy as detailed in the label
• Written informed consent where local regulations allow or require it

Exclusion Criteria:

• Patients should not receive concomitant therapy with telbivudine
• Co-infection with hepatitis A, hepatitis B or HIV
• Pregnant or breastfeeding women
• Patients with depression/mental diseases
• Neutrophil at baseline > 90.000/mm3
• Abnormal T4 or TSH

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL at 6 Months After End of Treatment	A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.	6 months
Percentage of Participants Who Become Hepatitis B Envelope Antigen-Negative and Anti-HBe-Positive During Treatment and at 6 and 12 Months After End of Treatment	HBeAg is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL During the Observation Period	A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL.	Up to 24 months
Percentage of Participants With Loss of Hepatitis B Envelope Antigen During the Observation Period	Loss of HBeAg is defined as the absence of HBeAg. A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) 'NEGATIVE' or (b) a quantitative result was lower than the reported lower detection limit.	Up to 24 months
Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid Suppression (<2,000 IU/mL) During the Observation Period	HBeAg seroconversion is defined as the absence of HBeAg and the presence of antibody to hepatitis B antigen (anti-HBe) . A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL.	Up to 24 months
Percentage of Participants Who Become Hepatitis B Envelope Antigen Negative During the Observation Period	HBeAg is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.	Up to 24 months
Incidence of Normalization of Serum Alanine Transaminase	Normalization of alanine transaminase (ALT) values means that ALT values out of the normal range returned to within the normal range.	Up to 24 months
Number of Participants With Incidence of Adverse Events	An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product	Up to 24 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: June 21, 2013
• First Submitted That Met QC Criteria: June 24, 2013
• First Posted (Estimate): June 25, 2013

Study Record Updates

• Last Update Posted (Estimate): June 22, 2016
• Last Update Submitted That Met QC Criteria: May 19, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic
• Other Study ID Numbers: ML27807