drugset / Trial / NCT04382937
Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary objective: To demonstrate non-inferiority in sustained virologic response (SVR, undetectable HCV RNA at Follow up week 12) between PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily for the treatment of chronic HCV genotype 2 infection
Timeline
- Start
- 2016-01-12
- Primary completion
- 2020-07-15
- Completion
- 2020-07-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | Subcutaneous |
| Comparator | Ribavirin | Small molecule | 800 mg | Oral |
| Comparator | Ribavirin | Small molecule | 1400 mg | Oral |
| Subject | Ropeginterferon alfa-2b | Protein / enzyme biologic | 400 ug | Subcutaneous |