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Trial record 42 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Hepatitis C Virus(HCV) Heart and Lung Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02858180
Recruitment Status : Completed
First Posted : August 8, 2016
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Duke University

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

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Heart Failure Pulmonary Disease, Chronic Obstructive Lung Diseases, Interstitial Drug: Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2016
Actual Primary Completion Date : April 11, 2019
Actual Study Completion Date : July 4, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

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 Name: 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 Name: Harvoni




Primary Outcome Measures :
  1. Completed Therapy [ Time Frame: 12-24 weeks of treatment ]
    The primary safety endpoint is the proportion of subjects who complete a full course of therapy, e.g. 12-24 weeks. This will be assessed by determining the number of subjects who withdraw from the study due to adverse events or serious adverse events.


Secondary Outcome Measures :
  1. Sustained Virologic Response (SVR) 12 [ Time Frame: 12 weeks after completing treatment ]
    The secondary outcome of efficacy will be determined by the proportion of subjects with hepatitis c virus ribonucleic acid (HCV RNA) below a measurable laboratory limit, 12 weeks after completing therapy.

  2. Sustained Virologic Response (SVR) 12 [ Time Frame: 4 weeks after completing treatment ]
    The secondary outcome of efficacy will be determined by the proportion of subjects with hepatitis c virus ribonucleic acid (HCV RNA) below a measurable laboratory limit.


Other Outcome Measures:
  1. Rates of discontinuation for Adverse Events and Serious Adverse Events [ Time Frame: Time of consent through final study visit (24-36 weeks) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858180


Locations
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United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48377
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center - Dept of Gastroenterology
Durham, North Carolina, United States, 27705
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Duke University
Gilead Sciences
Investigators
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Principal Investigator: Andrew Muir, MD Duke University

Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02858180     History of Changes
Other Study ID Numbers: Pro00069602
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Via manuscript
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Interstitial
Heart Failure
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Heart Diseases
Cardiovascular Diseases
Flaviviridae Infections
Respiratory Tract Diseases
Lung Diseases, Obstructive
Hepatitis, Chronic
Sofosbuvir
Antiviral Agents
Anti-Infective Agents