A Phase 4 interventional study of Peginterferon alfa 2 A and Peginterferon alfa 2 A, ribavirin + Epo Beta in Chronic Hepatitis C, sponsored by Dr. Conrado Fernandez. Completed at 28 sites in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-03-13.
Sponsored by Dr. Conrado Fernandez · Phase 4, Interventional, and Treatment
The rate of sustained virological response (SVR) in patients with chronic hepatitis C, genotype 3, high viral load and without rapid virological response (RNA-HCV negative at week 4) is low. Standard of care of these patients include treatment with weekly peginterferon plus 800 mg/day of ribavirin (RBV). Extended treatment to 48 weeks does not provide more clinical benefit than the standard duration. The main hypothesis is that higher dose of ribavirin may be better in terms of SVR than the standard dose.
Aims:
Design: Randomized controlled trial.
Patients will be randomly allocated into three arms:
Arm A : Peginterferon α-2a (180 μg/week)SC. plus Ribavirin (800 mg/day) p.o. over 24 weeks.
Arm B: Peginterferon α-2a (180 μg/week) plus Ribavirin (1600 mg/day) with support of Epoetin β (450 IU/kg/week) SC over 4 weeks:
B1.- If RNA-HCV undetectable at week 4, standard of care will be continued (Peginterferon α-2a, 180 μg/wee plus Ribavirin (800 mg/day) over 20 additional weeks).
B2.- If RNA-HCV were detectable at week 4, treatment will be continued with peginterferon α-2a (180 μg/week) plus RBV(1,600 mg/day) plus Epoetin β (450 UI/kg/week) over 20 additional weeks.
Sample size: 111 patients. To increase the SVR from 50% to 75%. Beta: 0.1; alfa: 0.05; Loss: 15%.
Randomization will be 1:2, 37 patients in Group A and 74 patients in group B.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 101 is close to the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →This is the only study on the registry with Dr. Conrado Fernandez as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this arm will receive standard of care (Peginterferon alfa 2A 180 mcg/weeks SC plus ribavirin 800 mg/day for 24 weeks).
Drug: Peginterferon alfa 2 A · Drug: ribavirin
After a period of 4 weeks with peginterferon alfa 2 a 180 mcg/week plus RBV 1600 mg/day (Induction phase), these patients will be allocated according to negativity or positivity of RNA-HCV at week 4. If RNA-HCV negative, treatment with peginterferon alfa 2 a 180 mcg/week plus RBV 800 mg/day (SOC) will be continued over 20 additional weeks (Arm B1). Epo β (450 IU/kg/week) will be administered as required to maintain hemoglobin \> 12g/dL.
Drug: Peginterferon alfa 2 A · Drug: Peginterferon alfa 2 A, ribavirin + Epo Beta · Drug: Peginterferon alfa 2 · Drug: ribavirin
If RNA-HCV at week 4 remains positive after the induction phase, then peginterferon alfa 2 a 180 mcg/week plus RBV 1600 mg/day will be continued for 20 additional weeks (Arm B2). Epo β (450 IU/kg/week) will be administered as required to maintain hemoglobin \> 12g/dL.
Drug: Peginterferon alfa 2 A · Drug: Peginterferon alfa 2 A, ribavirin + Epo Beta · Drug: ribavirin
Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 800 mg/day po (Control Group) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epoetin β (450 IU/kg/week) SC over 4 weeks (Arm B1) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epo beta 450 UI over four weeks (Arm B1) If RNA-HCV positive at week 4, Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day plus Epo beta 450 UI to keep Hb\>12 g/dL if required over 20 additional weeks (Arm B2)
Also known as: Pegasys
Ribavirin 1,600 mg/day plus peginterferon alfa 2A 180 mcg/week plus Epo beta 450 IU/Kg/day to maintain Hb\>12g/dl over 4 or 24 weeks
Also known as: Pegasys
RBV 1600 mg/day 24 weeks
Also known as: peginterferon alfa 2 a, Epoetin beta
ribavirin 800 mg/day for 24 weeks
Also known as: Pegasys
Peginterferon alfa 2 a 180 mcg/week for 4 weeks and then peginterferon alfa 2A for 20 weeks
Also known as: Pegasys
RBV 1600 mg/day 4 weeks and then ribavirin 800 mg/day 20 weeks
Also known as: Pegasys
Rate of patients with RNA-HCV negative in each arm at week 24 after the end of treatment.
Time frame: 1 year
Rate of patients with undetectable RNA-HCV in each arm at week 4 and 24 of treatment. Rate of adverse effects in each arm.
Time frame: 1 year
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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