Clareo Health | Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
HCV RNA \> 15 IU/mL at screening
HCV genotype 1 or 4
Chronic HCV infection (≥ 6 months)
Prior virologic failure after treatment with SOF in combination with simeprevir (SMV) ± RBV or with RBV ± pegylated interferon (PEG)
Cirrhotic and non-cirrhotic as determined by standard methods
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
You may not be if
Prior exposure to approved or experimental non-structural protein (NS5A) inhibitors
Prior exposure to nucleos(t)ide polymerase inhibitors, other than SOF
Pregnant or nursing female or male with pregnant female partner
Coinfection with HIV or hepatitis B virus
Current or prior history of clinical hepatic decompensation
Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
Chronic use of systemic immunosuppressive agents
History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
