Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection

Completed · Phase 2

Conditions studied: Hepatitis C

In brief

This study is to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial genotype 1 hepatitis C virus (HCV) infection.

Key facts

Study ID: NCT01924949
Run by: Gilead Sciences
People needed: 5
Starts: 2013-07-01
Expected to finish: 2014-08-01
Last updated by the study team: 2018-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Body mass index (BMI) greater than or equal to 18 kg/m\^2.
HCV RNA greater than or equal to 1000 IU/mL at screening.
Documented acquisition of nosocomial genotype 1 HCV infection within 36 months from the screening visit.
Screening laboratory values within predefined thresholds.
Use of two effective contraception methods if female of childbearing potential or sexually active male.
Healthy according to medical history and physical examination with the exception of HCV diagnosis.

You may not qualify if…

Unstable cardiac disease including subjects with active angina pectoris and/or hospitalization for a cardiac condition within 24 weeks prior to screening.
Prior exposure to an HCV NS5a inhibitor.
Pregnant or nursing female.
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
History of solid organ transplantation.
Current or prior history of clinical hepatic decompensation.
History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
Known hypersensitivity to LDV, SOF, or formulation excipients.

Where it is running

Study site — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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