A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive 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®) Plus Entecavir (Baraclude®) Combination Therapy on Quantitative Changes in HBeAg in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614471
• Other study ID #: ML20742
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2008
• Last updated: November 1, 2016
• Start date: August 2007
• Est. completion date: October 2009

Study information

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

Clinical Trial Summary

This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms s.c./week for 48 weeks, 2)PEGASYS 180 micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36 or 3) entecavir 0.5mg p.o. once daily for 24 weeks + PEGASYS 180 micrograms s.c./week from week 21 to 68. Treatment will be followed by 24 weeks treatment-free follow up. The anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for group 3, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-65 years of age;

• HBsAg positive, HBeAg positive and anti-HBe negative for at least 6 months, anti-HBs negative;

• absence of cirrhosis confirmed by liver biopsy in previous 12 months.

Exclusion Criteria:

• previous treatment for chronic hepatitis B within previous 6 months;

• antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months;

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

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

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:
• Entecavir
0.5mg po daily for 24 weeks
• Entecavir
0.5mg po daily from week 13 to week 36
• peginterferon alfa-2a [Pegasys]
180 micrograms sc/week for 48 weeks
• peginterferon alfa-2a [Pegasys]
180 micrograms sc/week from week 21 to week 68

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	Log change in quantitative HBeAg from baseline to 24 weeks after end of treatment.		Week 72 for Arms 1 and 2. Week 92 for Arm 3.	No
Secondary	HBeAg seroconversion, HBV-DNA <1000 copies/mL, loss of HBeAg, HBV DNA reduction, ALT normalization, loss of HBsAg seroconversion, reduction of HBsAg 24 weeks after end of treatment.		Week 72 for Arms 1 and 2. Week 92 for Arm 3.	No
Secondary	AEs, laboratory parameters.		Throughout study	No