NCT01172392

A Randomized Study to Assess the Loss of HbsAg After a 48-week Treatment Period With Pegylated Interferon Alpha 2a in Patients With Chronic Hepatitis B

A Randomized, Multicenter, Unblinded, Phase III Study Assessing the Loss of HbsAg at W96 After a 48-week Pegylated Interferon Alpha 2a in Patients With Chronic Hepatitis B (HbeAg Negative) Under Treatment and Responders (Undetectable Viral Load) to a Nucleoside(s) or Nucleotide(s) Analog(s) Treatment for at Least 12 Months. ANRS HB 06 Pegan

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the loss of HbsAg after a 48-week pegylated interferon alpha 2a in patients with chronic hepatitis B (HBeAg negativation)

Detailed description

The purpose of this study is to provide a therapeutical alternative to the use of an extended or undeterminated duration of treatment with prolonged nucleoside (s)/nucleotide (s)analog (s). The duration of administration is not consensual, and in most cases followed by a virological relapse, so that, the prolonged use could lead to the occurrence of viral resistance and mutations. It is therefore expected that treatment with pegylated interferon for 48 weeks in patients with undetectable HBV DNA by analog(s) may increase and promotes the loss of HbsAg and then promotes HbsAg seroconversion. In the absence of cirrhosis, the loss of HbsAg at 6 months would allow the end of treatment

Conditions

• Chronic Hepatitis B
• AgHbs Negativation

Interventions

Type	Name	Description
DRUG	Pegylated interferon-alpha-2a	180 mcg / wk / SC from D0 to W48
DRUG	Nucleotidic or Nucleosidic Treatment	Analog treatment according to investigators practice

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2010-07-29
• Last updated: 2013-03-29

Locations

1 site across 1 country: France