Hepatitis C Virus(HCV) Heart and Lung Study

April 8, 2020 updated by: Duke University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48377
        • Henry Ford Health System
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center - Dept of Gastroenterology
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic HCV Infection of Genotype 1, 4, 5, or 6
  • HCV RNA > 103 IU/mL at screening
  • 18 years of age or older
  • Diagnosis of chronic HCV infection, defined as positive HCV antibody or HCV RNA more than 6 months prior to screening OR an assessment of fibrosis F2 or greater prior to screening.

Subjects in the advanced heart failure cohort must meet all HCV criteria, and all of the following criteria:

  • New York Heart Association (NYHA) Class III or IV functional classification

    • NYHA Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.
    • NYHA Class IV: Patient with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
  • ejection fraction ≤ 30%
  • hospitalized for heart failure in last 12 months

Subjects in the advanced lung disease cohort must have been diagnosed with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) must meet all HCV criteria, and meet the following criteria for COPD or ILD:

  • ILD criteria: diagnosis of interstitial lung disease with chronic supplemental oxygen requirement at rest and/or with exertion.

  • COPD criteria (one of the following):

    • Forced expiratory volume (FEV1)< 30% predicted
    • OR any FEV1 with chronic supplemental oxygen requirement at rest and/or with exertion
    • OR any FEV1 with chronic hypercapnia (baseline partial pressure of arterial carbon dioxide [PaCO2] > 45)

Exclusion Criteria:

  • Chronic HCV Infection with Genotype 2 or 3

  • Treatment with any of the following agents

    • Amiodarone. Subjects previously treated with amiodarone must have stopped the amiodarone at least 60 days prior to day 1 of SOF/LDV FDC
    • Carbamazepine, phenytoin, phenobarbital, oxcarbazepine
    • Rifabutin, rifampin or rifapentine
    • HIV regimens containing tenofovir or tipranavir/ritonavir
    • St. John's wort
    • Rosuvastatin
  • Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
  • History of hepatic encephalopathy or variceal hemorrhage
  • Hepatitis B surface antigen positive

  • Abnormal hematological and biochemical parameters, including:

    • Hemoglobin (Hb) < 8 g/dL
    • Platelets ≤ 50,000/mm3
    • alanine aminotransferase (ALT), aspartase aminotransferase (AST), or alkaline phosphatase ≥ 10 times upper limit of normal(ULN)
    • Total bilirubin > 3 mg/dl
    • Severe renal impairment creatinine clearance (CrCl), i.e. < 30 mL/min.
  • History of major organ transplantation with an existing functional graft.
  • History of clinically-significant drug allergy to nucleoside/nucleotide analogs.
  • Pregnant women or women planning to become pregnant
  • Women who are breastfeeding
  • Active or recent history (≤ 1 year) of drug or alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Heart Failure Cohort

Harvoni (sofosbuvir/ledipasvir fixed dose combination)

1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV)
Drug: Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)
1 pill once daily of SOF/LDV FDC
Other Names:
  • Harvoni
EXPERIMENTAL: Lung Disease Cohort

Harvoni (sofosbuvir/ledipasvir fixed dose combination)

1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir
Drug: Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)
1 pill once daily of SOF/LDV FDC
Other Names:
  • Harvoni

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Completed 24 Weeks of Therapy
Time Frame: 24 weeks
The primary safety endpoint is the number of subjects who complete a full course of therapy.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Sustained Virologic Response (SVR) 12
Time Frame: 12 weeks after completing treatment
The secondary outcome of efficacy will be determined by the number of subjects with hepatitis c virus ribonucleic acid (HCV RNA) below a measurable laboratory limit, 12 weeks after completing therapy.
12 weeks after completing treatment
Number of Subjects With Sustained Virologic Response (SVR) 4
Time Frame: 4 weeks after completing treatment
The secondary outcome of efficacy will be determined by the number of subjects with hepatitis c virus ribonucleic acid (HCV RNA) below a measurable laboratory limit, 4 weeks after completing treatment.
4 weeks after completing treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discontinuation for Adverse Events and Serious Adverse Events
Time Frame: 12 weeks after completing treatment
Assessment for discontinuation due to adverse events and serious adverse events, as addressed by adverse events and laboratory tests. Final study visit is 12 weeks after treatment.
12 weeks after completing treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ACTUAL)

April 11, 2019

Study Completion (ACTUAL)

July 4, 2019

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (ESTIMATE)

August 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00069602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Via manuscript

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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