Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
15 participants
INTERVENTIONAL
2016-12-31
2019-07-04
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Heart Failure Cohort
Harvoni (sofosbuvir/ledipasvir fixed dose combination)
1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV)
Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)
1 pill once daily of SOF/LDV FDC
Lung Disease Cohort
Harvoni (sofosbuvir/ledipasvir fixed dose combination)
1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir
Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)
1 pill once daily of SOF/LDV FDC
Interventions
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Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)
1 pill once daily of SOF/LDV FDC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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Andrew Muir, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Henry Ford Health System
Detroit, Michigan, United States
Columbia University Medical Center
New York, New York, United States
Duke University Medical Center - Dept of Gastroenterology
Durham, North Carolina, United States
Harborview Medical Center
Seattle, Washington, United States
Countries
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References
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Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013 Apr;57(4):1333-42. doi: 10.1002/hep.26141. Epub 2013 Feb 4.
Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006 May 16;144(10):705-14. doi: 10.7326/0003-4819-144-10-200605160-00004.
Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009 Apr;49(4):1335-74. doi: 10.1002/hep.22759. No abstract available.
Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Brau N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11.
Feld JJ, Kowdley KV, Coakley E, Sigal S, Nelson DR, Crawford D, Weiland O, Aguilar H, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014 Apr 24;370(17):1594-603. doi: 10.1056/NEJMoa1315722. Epub 2014 Apr 10.
Lee I, Localio R, Brensinger CM, Blumberg EA, Lautenbach E, Gasink L, Amorosa VK, Lo Re V 3rd. Decreased post-transplant survival among heart transplant recipients with pre-transplant hepatitis C virus positivity. J Heart Lung Transplant. 2011 Nov;30(11):1266-74. doi: 10.1016/j.healun.2011.06.003. Epub 2011 Jul 20.
Fagiuoli S, Minniti F, Pevere S, Farinati F, Burra P, Livi U, Naccarato R, Chiaramonte M. HBV and HCV infections in heart transplant recipients. J Heart Lung Transplant. 2001 Jul;20(7):718-24. doi: 10.1016/s1053-2498(01)00255-8.
Sahi H, Zein NN, Mehta AC, Blazey HC, Meyer KH, Budev M. Outcomes after lung transplantation in patients with chronic hepatitis C virus infection. J Heart Lung Transplant. 2007 May;26(5):466-71. doi: 10.1016/j.healun.2007.01.037. Epub 2007 Mar 26.
Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, Nahass R, Ghalib R, Gitlin N, Herring R, Lalezari J, Younes ZH, Pockros PJ, Di Bisceglie AM, Arora S, Subramanian GM, Zhu Y, Dvory-Sobol H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Sulkowski M, Kwo P; ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17;370(16):1483-93. doi: 10.1056/NEJMoa1316366. Epub 2014 Apr 11.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro00069602
Identifier Type: -
Identifier Source: org_study_id
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