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

Hepatitis B, Chronic Clinical Trial

Official title:

An Open Label Study Evaluating Safety and the Effect of PEGASYS® on HBV DNA Levels in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436163
• Other study ID #: ML20601
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2007
• Last updated: April 2, 2016
• Start date: March 2007
• Est. completion date: May 2010

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia:State Agency of Medicines of Estonia
• Study type: Interventional

Clinical Trial Summary

This single arm study will evaluate the efficacy and safety of PEGASYS in treatment-naive Baltic patients with HBeAg-positive chronic HBV. All patients will receive PEGASYS 180 micrograms s.c. once weekly. Following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-70 years of age;

• HBeAg positive, HBsAg positive for >=6 months;

• anti-HBs negative;

• HBV DNA >500,000 copies/mL.

Exclusion Criteria:

• previous antiviral or interferon-based therapy for CHB;

• evidence of decompensated liver disease;

• chronic liver disease other than viral hepatitis;

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

• co-infection with human immunodeficiency virus (HIV).

Study Design

Endpoint Classification: Safety/Efficacy Study, 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

Countries where clinical trial is conducted

Estonia,  Latvia,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with HBV DNA <100,000 copies/mL		Week 72	No
Secondary	HBV DNA <400 copies/mL, HBsAg seroconversion, ALT normalization, sustained HBe seroconversion.		Weeks 48 and 72	No
Secondary	AEs, laboratory parameters.		Throughout study	No