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.
Conditions
Interventions
Trade Name: Multiferon
Pharmaceutical Form: Solution for injection
Sponsors
Karolinska Universitetssjukhuset
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria: Patients with concomitant diseases/conditions which are contraindications for treatment with IFN and ribavirin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. This study is an exploratory study. | — |
Countries
Sweden
Outcome results
None listed