Clinical study of cerebral function in chronic hepatitis C virus patients treated with pegylated interferon alpha-2a and ribivirin - SKS-0078

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005707-18-DK

Enrollment

Registered

2008-06-04

Start date

2008-08-07

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

HCV MedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C

Interventions

Trade Name: Pegasys Pharmaceutical Form: Solution for injection Other descriptive name: PEGINTERFERON ALFA 2A Trade Name: Copegus Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIBAVIRI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: anti-HCV and measurable HCV RNS Genotype 1, 2 and 3 Age 18-59 years 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: anti-HCV treatment experienced patients HIV HBV (+HBsAg) Liver cirrhosis (metavir score > 3) Pregnancy Alcohol and/or drug abuse

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess cerebral function in chronic hepatitis C virus patients before and after therapy with pegylated interferon alpha and ribivirin. ;Secondary Objective: To measure changes in HCV RNA viral load and sequences, in addition to cytokin levels following therapy ;Primary end point(s): Cognitive function and other neuro-psychological aspects MR detectable micro-structural lesions	—

Countries

Denmark

Outcome results

None listed

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