NCT02858180

Hepatitis C Virus(HCV) Heart and Lung Study

A Multicenter, Open-label Study of Harvoni ® (Sofosbuvir Ledipasvir Fixed Dose Combination) in Subjects Infected With Chronic Hepatitis C and Advanced Heart Failure or Lung Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter study in Hepatitis C Virus (HCV) infected adult patients who also have advanced cardiac disease or advanced lung disease.

Detailed description

This is a multicenter study in HCV infected adult patients who also have either advanced cardiac disease, or advanced lung disease. Advanced cardiac disease is defined as a marked limitation of physical activity, or discomfort upon physical activity. The patients in the advanced cardiac disease group must also have been hospitalized for heart failure within the last 12 months. Advanced lung disease is defined as patients who have been diagnosed with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD). Patients in the COPD group must have abnormalities in their forced expiratory volume (FEV) test, which measures the amount of air exhaled. They may or may not need supplemental oxygen. Patients in the ILD group must have been diagnosed with ILD and require supplement oxygen at all times.

Conditions

• Hepatitis C, Chronic
• Heart Failure
• Pulmonary Disease, Chronic Obstructive
• Lung Diseases, Interstitial

Interventions

Type	Name	Description
DRUG	Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)	1 pill once daily of SOF/LDV FDC

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-04-11
• Completion: 2019-07-04
• First posted: 2016-08-08
• Last updated: 2020-04-21
• Results posted: 2020-04-21

Locations

4 sites across 1 country: United States