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A multicenter, randomized, controlled study comparing the efficacy and safety of 48 weeks of 40kD branched pegylated interferon alfa-2a (PEGASYS, Ro 25-8310) versus 96 weeks of PEGASYS, alone or in combination with 100 mg lamivudine for 48 weeks in patients with HBeAg-negative chronic hepatitis B.

A multicenter, randomized, controlled study comparing the efficacy and safety of 48 weeks of 40kD branched pegylated interferon alfa-2a (PEGASYS, Ro 25-8310) versus 96 weeks of PEGASYS, alone or in combination with 100 mg lamivudine for 48 weeks in patients with HBeAg-negative chronic hepatitis B.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002985-39-IT
Enrollment
Unknown
Registered
2005-09-07
Start date
2004-12-13
Completion date
Unknown
Last updated
2012-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of chronic hepatitis B, HBeAg-negative MedDRA version: 14.1 Level: PT Classification code 10019731 Term: Hepatitis B System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Pegasys Product Name: BMS-284756 Product Code: NA Pharmaceutical Form: Solution for injection INN or Proposed INN: Peginterferon alfa-2a Current Sponsor code: CDP-870 Concentration unit: µ

Sponsors

ROCHE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026