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

Hepatitis C Clinical Trial

Official title:

An Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Nosocomial Genotype 1 HCV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924949
• Other study ID #: GS-US-337-0125
• Status: Completed
• Phase: Phase 2
• Start date: July 2013
• Est. completion date: August 2014

Study information

• Verified date: May 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• LDV/SOF
Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg FDC tablet administered orally once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Primary	Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event		Up to 12 weeks
Secondary	Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.	Posttreatment Weeks 4 and 24
Secondary	Percentage of Participants With HCV RNA < LLOQ on Treatment		Up to 12 weeks
Secondary	HCV RNA Change From Baseline		Baseline; Weeks 1, 4, and 8
Secondary	Percentage of Participants Experiencing Virologic Failure	Virologic failure was defined as; On-treatment virologic failure: Breakthrough (confirmed HCV RNA = LLOQ after having previously had HCV RNA < LLOQ while on treatment), or; Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or; Non-response (HCV RNA persistently = LLOQ through 8 weeks of treatment); Virologic relapse: Confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.	Baseline to posttreatment Week 24