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Randomised phase 3B study on comparison of 2 treatment schedules with peginterferon alpha 2b and ribavirin short term versus standard term schedules in patients with chronic hepatitis C, genotype 2 or 3 and early virologic response comparison of efficacy, tolerability, quality of life and costs. - ND

Randomised phase 3B study on comparison of 2 treatment schedules with peginterferon alpha 2b and ribavirin short term versus standard term schedules in patients with chronic hepatitis C, genotype 2 or 3 and early virologic response comparison of efficacy, tolerability, quality of life and costs. - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000279-40-IT
Enrollment
Unknown
Registered
2007-03-13
Start date
2007-02-15
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

Patients with chronic hepatitis C with genotype 2 or 3 MedDRA version: 9.1 Level: LLT Classification code 10019744 Term: Hepatitis C

Interventions

Trade Name: PEGINTRON Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Peginterferon alfa-2b Concentration unit: µg microgram(s) Concentration type: equal Concentration numb

Sponsors

A.S.L. 2
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with chronic hepatitis C with genotype 2 or 3 Age 18-65 years providing informed consent 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: Patients unable to provide informed consent Pregnancy or inadequate contraceptions Depression, epilepsy, renal failure and cardiac failure Autoimmune diseases Cirrhosis clinically evident or biopsy proven Previous antiviral treatment with interferon or interferon and ribavirin Co-infections HIV/HCV Co-infections HBV/HCV

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the clinical impact elegibility, efficacy and quality of life of a short course of treatment Peginterferon alpha 2b 1.5 mcg/Kg/sett ribavirin 800 mg/day for 16 weeks in comparison with a standard course of treatment Peginterferon alpha 2b 1.5 mcg/Kg/sett ribavirin 800 mg/day for 24 weeks ;Secondary Objective: Analysis of primary and secondary costs of the 2 schelules of treatment;Primary end point(s): -Comparison of sustained viral response rate between the short term schedule 16 weeks versus the standard schedule 24 weeks -Comparison of Quality of life parameters assessed by Chronic Liver Disease Questionnaire, CLDQ-1 Italian version and of indirect costs assessed by Health Labour Questionnaire between the short term schedule 16 weeks versus the standard schedule 24 weeks—

Countries

Italy

Outcome results

None listed

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