Hepatitis C, ChronicPhase 4NCT02858180
Hepatitis C Virus(HCV) Heart and Lung Study
A Phase 4 study testing Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC) in people with Hepatitis C, Chronic and Heart Failure, run by Duke University at 4 sites in United States.
Trial summary
This is a multicenter study in Hepatitis C Virus (HCV) infected adult patients who also have advanced cardiac disease or advanced lung disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Heart Failure, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2016to 4 Jul 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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)
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Henry Ford Health System
Detroit, Michigan, 48377
Duke University Medical Center - Dept of Gastroenterology
Durham, North Carolina, 27705
Columbia University Medical Center
New York, New York, 10032
Harborview Medical Center
Seattle, Washington, 98104
About this study
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
This is a multicenter study in Hepatitis C Virus (HCV) infected adult patients who also have advanced cardiac disease or advanced lung disease.
Read the 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
- Being tested
- Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)
- Medical subject headings
- Hepatitis C, Chronic, Heart Failure, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)Drug
Also called Harvoni
1 pill once daily of SOF/LDV FDC
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Cohort | Experimental | Harvoni (sofosbuvir/ledipasvir fixed dose combination)
1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV) Receives: Drug: Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC) |
| Lung Disease Cohort | Experimental | Harvoni (sofosbuvir/ledipasvir fixed dose combination)
1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir Receives: Drug: Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Completed 24 Weeks of Therapy
The primary safety endpoint is the number of subjects who complete a full course of therapy.
Measured: 24 weeks
Secondary outcomes (2)
Number of Subjects With Sustained Virologic Response (SVR) 12
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.
Measured: 12 weeks after completing treatment
Number of Subjects With Sustained Virologic Response (SVR) 4
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.
Measured: 4 weeks after completing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startDec 2016
- Primary completion11 Apr 2019
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Andrew Muir, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858180
- Sponsor's protocol ID
- Pro00069602
- Status last verified
- Apr 2020
- First submitted
- 1 Aug 2016
- Last updated
- 21 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Via manuscript
Publications
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.
PubMed 23172780Armstrong 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.
PubMed 16702586Ghany 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.
PubMed 19330875Afdhal 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.
PubMed 24725239Feld 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.
PubMed 24720703Lee 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.
PubMed 21764330Fagiuoli 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.
PubMed 11448796Sahi 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.
PubMed 17449415Afdhal 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.
PubMed 24725238
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02858180
- Acronym / sponsor ID
- Pro00069602
- Conditions
- Hepatitis C, Chronic, Heart Failure, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Dec 2016
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Posted 21 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Cohort | Experimental | Drug: Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV) |
| Lung Disease Cohort | Experimental | Drug: Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (22 listed)
- Chronic HCV Infection with Genotype 2 or 3
- Treatment with any of the following agents
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)Also: Harvoni1 pill once daily of SOF/LDV FDC | Drug | Heart Failure Cohort, Lung Disease Cohort |
Primary outcome
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.
2 secondary outcomes
Number of Subjects With Sustained Virologic Response (SVR) 12
Time frame: 12 weeks after completing treatment
Number of Subjects With Sustained Virologic Response (SVR) 4
Time frame: 4 weeks after completing treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23172780Mohd 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.
- Background: PubMed 16702586Armstrong 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.
- Background: PubMed 19330875Ghany 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.
- Background: PubMed 24725239Afdhal 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.
- Background: PubMed 24720703Feld 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.
- Background: PubMed 21764330Lee 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.
- Background: PubMed 11448796Fagiuoli 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.
- Background: PubMed 17449415Sahi 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.
- Background: PubMed 24725238Afdhal 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.
- Individual participant dataSharing planned: Yes. Via manuscript
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Muir, MD principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC) in people with Hepatitis C, Chronic and Heart Failure, run by Duke University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Who Completed 24 Weeks of Therapy (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02858180, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.