A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.

Hepatitis B, Chronic Clinical Trial

Official title:

An Open Label Study of the Effect of PEGASYS on Treatment Response in Patients With HBeAg-positive or HBeAg-negative Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487747
• Other study ID #: ML20003
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2007
• Last updated: February 15, 2010
• Est. completion date: October 2009

Study information

• Verified date: February 2010
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Federal Agency of drug quality control
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks 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: 19
• Est. completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-70 years of age;

• chronic hepatitis B;

• HBV DNA >100,000 copies/mL.

Exclusion Criteria:

• previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months;

• evidence of decompensated liver disease;

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

• coinfection with hepatitis A, C or D, or HIV.

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 [Pegasys]
180 micrograms sc 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

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV DNA <100,000 copies/mL (HBeAg positive patients)		Week 96	No
Primary	HBV DNA <20,000 copies/mL (HBeAg negative patients)		Week 96	No
Secondary	HBV DNA <400 copies/mL, HbsAg seroconversion, ALT normalization, sustained HBe seroconversion in HBeAg positive patients.		Weeks 48 and 96	No
Secondary	AEs and laboratory parameters		Throughout study	No