A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.

Hepatitis B, Chronic Clinical Trial

Official title:

An Open Label Phase IV Multicenter Study for Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Patients With HBeAg Positive Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519921
• Other study ID #: ML18495
• Status: Completed
• Phase: Phase 4
• First received: January 5, 2012
• Last updated: January 25, 2016
• Start date: October 2005
• Est. completion date: June 2008

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Korea Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients, 18-65 years of age

• HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve

• Detectable HBV DNA (>100,000 copies/mL)

Exclusion Criteria:

• Coinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV)

• Evidence of decompensated liver disease

• A medical condition associated with chronic liver disease other than viral hepatitis

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• peginterferon alfa-2a [Pegasys]
Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Hepatitis B Virus DNA (HBV-DNA) <100,000 Copies/mL	Participants who had HBV-DNA levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.	Week 72	No
Primary	Percentage of Participants With Hepatitis B Virus e Antigen (HBeAg) Loss	Participants with loss of HBeAg at the EOF period (24 weeks after the end of treatment) were classified as responders.	Week 72	No
Secondary	Percentage of Participants With Alanine Aminotransferase (ALT) Normalization	Participants with ALT less than the ULN (upper limit of normal) at end of treatment (EOT) and EOF period were responders.	Week 48 and Week 72	No
Secondary	Percentage of Participants With HBV-DNA Below the Limit of Detection	Participants with HBV-DNA below the limit of detection i.e. <174 copies/mL at EOT and EOF period were responders.	Week 48 and Week 72	No
Secondary	Percentage of Participants With a Combined Response	A responder with Combined Response was a participant with HBV-DNA<100,000 copies/mL, HBeAg seroconversion (i.e. loss of HBeAg and presence of anti-HBe) and ALT normalization at EOT and EOF period.	Week 48 and Week 72	No
Secondary	Percentage of Participants With HBeAg Seroconversion	A responder was a participant with loss of HBeAg and presence of anti-HBe at EOT and EOF period.	Week 48 and Week 72	No
Secondary	Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg)	A responder was a participant who were analysed with loss of HBsAg at EOT and EOF period.	Week 48 and Week 72	No
Secondary	Percentage of Participants With HBsAg Seroconversion	A responder was a participant with loss of HBsAg and presence of anti-HBs at EOT and EOF period.	Week 48 and Week 72	No
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An adverse event was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Participants with AEs and SAEs have been presented.	Up to Week 72	No