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A randomized, open label, multicenter, parallel group study evaluating the efficacy and safety of 135 mcg and 90 mcg of Pegasys given as monotherapy to patients with chronic hepatitis C and end-stage renal disease undergoing hemodialysis.

A randomized, open label, multicenter, parallel group study evaluating the efficacy and safety of 135 mcg and 90 mcg of Pegasys given as monotherapy to patients with chronic hepatitis C and end-stage renal disease undergoing hemodialysis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-004852-38-IT
Enrollment
80
Registered
2007-02-06
Start date
2005-04-06
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

chronic hepatitis C CHC virus infection in patients with end-stage renal disease ESRD undergoing hemodialysis MedDRA version: 6.1 Level: PT Classification code 10019744

Interventions

Trade Name: L03AB11-Peginterferone alfa -2a interferone alfa -2a pegilato Pegasis sc sir 0,5 135mcg +AG Pharmaceutical Form: Solution for injection INN or Proposed INN: Peginterferon alfa-2a Current S

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: 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