A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)

Hepatitis B, Chronic Clinical Trial

Official title:

A Randomized, Open-label Study of 2 Different Treatment Durations of PEGASYS With or Without Lamivudine on ALT and HBV DNA Levels/Correction in Patients With HBeAg-negative Chronic Hepatitis B Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095835
• Other study ID #: ML18253
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2010
• Last updated: March 1, 2016
• Start date: February 2005
• Est. completion date: January 2010

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study will compare the efficacy and safety of 2 different durations of treatment with PEGASYS, in patients with HBeAg-negative chronic HBV. It will also compare PEGASYS treatment alone and in combination with lamivudine. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: January 2010
• Est. primary completion date: January 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-negative chronic hepatitis B for >=6 months;

• liver disease consistent with chronic hepatitis B.

Exclusion Criteria:

• interferon-based, systemic anti-HBV, antiviral, anti-neoplastic, or immunomodulatory therapy <=12 months before first dose of study drug;

• nonresponders to previous interferon therapy;

• co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV);

• hepatocellular cancer;

• compensated (Child A, score 6) or decompensated liver disease (Child B or C).

Study Design

Allocation: Randomized, 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]
1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Alanine aminotransferase normalization plus lowering of HBV-DNA levels to <20,000 copies/mL at end of follow-up period\n		at the end of study treatment (either 48 or 96 weeks from treatment start), and at weeks 24 and 48 of follow-up period	No
Secondary	Efficacy: ALT normalization plus lowering of HBV-DNA levels to <20,000 copies/mL, HBV-DNA below limit of quantification, and HBsAg loss and anti-HBs seroconversion at EoT, end of follow-up, and 24 weeks' follow-up\nSafety: AEs, vital signs, lab values\n		at the end of study treatment (either 48 or 96 weeks from treatment start, according to study arm), and at weeks 24 and 48 of follow-up period	No