A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)

Hepatitis B, Chronic Clinical Trial

Official title:

Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (Pegasys®) in Patients With HBeAg-Positive Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604823
• Other study ID #: ML17700
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2015
• Last updated: November 1, 2016
• Start date: November 2003
• Est. completion date: November 2005

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: CFDA
• Study type: Interventional

Clinical Trial Summary

This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult participants between 18 to 65 years of age

• HBeAg-positive chronic HBV

• Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.

Exclusion Criteria:

• Antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment

• Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV)

• Evidence of decompensated liver disease

• Medical condition associated with chronic liver disease other than viral hepatitis.

Study Design

Allocation: Non-Randomized, 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
Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with HBV deoxyribonucleic acid (DNA) less than (<) 100,000 copies per milliliters (copies/mL)		72 weeks	No
Primary	Percentage of participants with HBeAg seroconversion		72 weeks	No
Secondary	Number of participants who achieved HBV DNA levels below limit of detection		Weeks 48 and 72	No
Secondary	Number of participants with HBsAg loss		Weeks 48 and 72	No
Secondary	Number of participants with both Hepatitis B Surface Antigen (HBsAg) loss and presence of Anti-HBs		Weeks 48 and 72	No
Secondary	Number of participants with alanine aminotransferase (ALT) normalization		Weeks 48 and 72	No
Secondary	Number of participants with combined response (HBV DNA <100,000 copies/mL, HBeAg loss, and ALT normalization)		Weeks 48 and 72	No
Secondary	Incidence of adverse events		up to 72 weeks	No