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

Hepatitis B, Chronic Clinical Trial

Official title:

A Randomized, Open-label Study of the Effect of Peginterferon Alfa-2a (40KD)(PEGASYS) in Combination With Adefovir or Entecavir on HBeAg Seroconversion in Patients With HBeAg Positive Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922207
• Other study ID #: ML21827
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2009
• Last updated: October 20, 2015
• Start date: May 2010
• Est. completion date: September 2014

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan:DOH
• Study type: Interventional

Clinical Trial Summary

This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-65 years of age;

• HBeAg+ve for >=3 months;

• positive serum HBV DNA within 3 months prior to entry;

• patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues;

• >=3 months treatment-free interval from nucleotide analogues.

Exclusion Criteria:

• evidence of decompensated liver disease;

• history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis;

• co-infection with active hepatitis A,C or D, or HIV.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Adefovir
From week -4 to week 2
• Entecavir
From week -4 to week 2
• Placebo
From week -4 to week 2
• peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly, from week 1-48

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment	HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).	Week 100	No
Secondary	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	HBV DNA (copies per milliliter [copies/mL]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.	Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	No
Secondary	Percentage of Participants Who Were HBeAg Negative		Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	No
Secondary	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive		Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	No
Secondary	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	The normal range for ALT is 10 to 40 international units per liter (IU/L).	Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100	No
Secondary	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100		Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	No
Secondary	Percentage of Participants With Combined Response	Combined response was defined as having negative HBeAg, HBV DNA less than (<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).	Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	No