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Clinical Trial 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


Clinical Trial Description

Secondary objective: To determine and compare the efficacy, safety, tolerability and immunogenicity of 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04382937
Study type Interventional
Source PharmaEssentia
Contact
Status Completed
Phase Phase 3
Start date January 12, 2016
Completion date July 15, 2020

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