FindTrial
Sign In

Treatment with leucocytic interferon-alpha more ribavirine towards peg-interferon to reduced doses more ribavirine in patients affections from positive chronic hepatitis HCV that in course of arranged therapy demand the reduction of the peghilato dosage of interferon. - ND

Treatment with leucocytic interferon-alpha more ribavirine towards peg-interferon to reduced doses more ribavirine in patients affections from positive chronic hepatitis HCV that in course of arranged therapy demand the reduction of the peghilato dosage of interferon. - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005161-11-IT
Enrollment
200
Registered
2006-03-14
Start date
2005-08-01
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 FROM VIRUS C MedDRA version: 6.1 Level: PT Classification code 10019744

Interventions

Trade Name: ALFAFERONE INIET.1F3000000UI Pharmaceutical Form: Solution for injection INN or Proposed INN: Interferon alfa natural Concentration unit: IU international unit(s) Concentration type: equal

Sponsors

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients affections from correlated chronic hepatitis HCV 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: Absolute contraindications to use of the peg-interferone and/or the ribavirine.

Design outcomes

Primary

MeasureTime frame
Main Objective: To estimate if, in the patients who in course of arranged therapy manifest abnormality of laboratory or adverse events, the passage to an other type of interferon concurs the completion of the therapy with full doses with consequent therapeutic benefit for the patient.;Secondary Objective: To estimate the safety of the leucocytic interferon-alpha more ribavirine to the doses standard.;Primary end point(s): - Evaluation of the type, frequency, intensity and severity of the adverse events - Evaluation of ETR End of Treatment Response , biochemistry and virological in the patients who have completed the treatment—

Countries

Italy

Outcome results

None listed

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