A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B

Hepatitis B, Chronic Clinical Trial

Official title:

A Randomized, Open-label Study Evaluating the Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) or Adefovir Dipivoxil (ADV) in Patients With Lamivudine-resistant HBeAg Positive Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598063
• Other study ID #: ML18376
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2015
• Last updated: February 1, 2016
• Start date: October 2005
• Est. completion date: April 2009

Study information

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

Clinical Trial Summary

This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target sample size is 255 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult participants 18-65 years of age

• Hepatitis B surface antigen (HBsAg)-positive, HBeAg-positive, and anti-HBs-negative for greater than or equal to (>=) 6 months

• Receiving lamivudine currently, and for >=6 months

• hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) decreased >=2 log during lamivudine treatment on >=1 occasion

• Absence of cirrhosis confirmed by liver biopsy in previous 6 months

Exclusion Criteria:

• Other drugs with activity against HBV within the prior 6 months, except lamivudine

• Antiviral, anti-neoplastic, or immunomodulatory therapy less than or equal to (<=) 6 months before study - Active infection with hepatitis A, C, or D virus, or human immunodeficiency virus

• Decompensated liver disease

• Medical condition associated with another chronic liver disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Adefovir dipivoxil
ADV will be administered orally at a dose of 10 mg QD for 72 weeks.
• Lamivudine
Lamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks.
• Peginterferon alfa-2a
Peginterferon alfa-2a injection will be administered at a dose of 180 mcg QW for 48 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at Week 72		Week 72	No
Secondary	Loss of HBeAg		Week 48, and 72	No
Secondary	Reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA)		Week 48, and 72	No
Secondary	Alanine transaminase (ALT) normalization		Week 48, and 72	No
Secondary	Hepatitis B surface antigen (HBsAg) seroconversion		Week 48, and 72	No