Multiferon treatment of non-responders to peg-IFN alfa plus ribavirin standard of care treatment - a study of the early viral kinetics during the initial 12 weeks treatment. - IFN-Multiferon08

Conditions: HCV RNA response to a multivalent IFN (Multiferon 6 MU q.d. + ribavirin standard dosed) in prior non-responders to SOC (peg-IFN + ribavirin) during treatment the initial 12 weeks. Results of HCV RNA decline weeks 4 and 12 with SOC and this new treatment will be compared.

Registration Number: EUCTR2008-007104-28-SE

Lead Sponsor: Karolinska Universitetssjukhuset

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 20

Inclusion Criteria

10-20 patients earlier treated with peg-IFN alfa-2a 180 mcg q.w. in combination with RBV dosed 1000/1200 mg per day (weight <75/>75 kg) in whom results of HCV RNA quantification at baseline, week 4 and 12 as measured by the TaqMan Roche test (sensitivity 15 IU/mL) are available will be recruited.
These patients have a well documented prior treatment but should have failed to achive EVR treatment week 12 during SOC treatment.

Are the trial subjects under 18?
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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with concomitant diseases/conditions which are contraindications for treatment with IFN and ribavirin

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To see if non-responders to SOC (peg-IFN plus ribavirin (RBV)) in whom the HCV RNA decay during SOC has been measured at baseline and weeks 4 and 12 during treatment will respond to Multiferon in combination with RBV with a more pronounced decay of HCV RNA, and if they can achieve complete or partial early viral response (EVR) treatment week 12.;Secondary Objective: ;Primary end point(s): The HCV RNA decay at treatment week 4 and 12 compared to that seen earlier in the same patients when they were treated with SOC treatment.<br>This study is an exploratory study.

Secondary Outcome Measures