A study with Ledipasvir/Sofosbuvir for adolecents and children with chronic Hepatitis C infection

Update Il y a 4 ans
Reference: EUCTR2014-003578-17

Woman and Man

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Extract

The primary objective of the PK Lead-in Phase of this study is: - To evaluate the steady state pharmacokinetics (PK) and confirm the dose of LDV/SOF FDC in chronic HCV-infected pediatric subjects The primary objective of the Treatment Phase of this study is: - To evaluate the safety and tolerability of LDV/SOF FDC +/- RBV for 12 or 24 weeks in chronic HCV-infected pediatric subjects


Inclusion criteria

  • Chronic hepatitis C virus infection

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