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TerminatedNCT03207399Updated Sep 11, 2019Results posted

Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

A Phase 4 interventional study of Epclusa in Hepatitis C, Chronic and Lung Transplant, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-11.

Sponsored by Duke University · Phase 4, Interventional, and Treatment

Why this study was terminated
Enrollment terminated due to not having any other eligible participants.
Phase
Phase 4
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate whether treatment with Epclusa (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C infection is feasible, safe and effective at curing HCV.

02

Conditions studied

  • Hepatitis C, Chronic
  • Lung Transplant
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 1 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • HCV RNA >= 10\^3 IU/ml at screening
  • Chronic HCV infection, defined as positive HCV antibody and/or HCV RNA more than 6 months prior to screening
  • HCV Genotype 1, 2, 3, 4, 5 or 6
  • Otherwise eligible for lung transplant at study site

Exclusion criteria

Exclusion Criteria:

  • Age \<18

  • 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 SOF/VEL
    • Carbamazepine, phenytoin, phenobarbital, oxcarbazepine
    • Rifabutin, rifampin or rifapentine
    • HIV regimens containing tenofovir or tipranavir/ritonavir
    • St John's wort
    • PPIs, including: Omeprazole, pantoprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole
    • Modafinil
  • Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance
  • Hepatitis B surface antigen positive
  • History of hepatic encephalopathy or variceal hemorrhage

  • Abnormal hematological and biochemical parameters, including:

    • Hemoglobin \<8g/dL
    • Platelets \<= 50,000/mm\^3
    • ALT (alanine aminotransferase), AST (aspartase aminotransferase) or alkaline phosphatase >=10 times ULN
    • Total bilirubin >3mg/dL
    • Severe renal impairment, ie creatinine clearance (CrCl) \<30mL/min
  • Pregnant women or women planning to become pregnant
  • Women or are breastfeeding
  • Active or recent history (\<=1 year) of drug or alcohol abuse
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Other
    Epclusa

    Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.

    Drug: Epclusa

Interventions

  • DrugEpclusa

    Patients will be treated with this drug for 12 weeks post lung transplant.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.

    Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA.

    Time frame: 12 weeks

  2. Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA

    Adverse events resulting in discontinuation of EPCLUSA

    Time frame: 1 year

  3. Number of Patients Eligible for EPCLUSA Treatment

    Eligibility for EPCLUSA treatment within 12 months of lung transplant

    Time frame: within 12 months of lung transplant

Secondary outcomes

  1. Change in Serum HCV RNA Levels

    Serum HCV RNA levels at 12-, 24-, and 48-weeks after initiation of EPCLUSA

    Time frame: 12, 24, and 48 weeks after initiation of EPCLUSA

  2. Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy

    Adverse events requiring temporary interruption in EPCLUSA therapy

    Time frame: 1 year

  3. Patient Survival

    90-day post transplant patient survival

    Time frame: 90 days post-transplant

  4. Patient Survival

    1 year post transplant patient survival

    Time frame: 1 year post-tranplant

  5. Patient Survival

    90-day post transplant patient survival in recipients of HCV NAT positive donor organ

    Time frame: 90 days post-transplant

  6. Patient Survival

    1 year post transplant patient survival in recipients of HCV NAT positive donor organ

    Time frame: 1 year post-transplant

07

Results

Posted Sep 11, 2019
Limitations and caveats
Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Participant flow

Participant flow — Overall Study
MilestoneEpclusa
Started1
Completed1
Not completed0

Outcome measures

PrimaryNumber of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.

Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA.

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.
ParticipantsEpclusa
Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.1
PrimaryNumber of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA

Adverse events resulting in discontinuation of EPCLUSA

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA
ParticipantsEpclusa
Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA0
PrimaryNumber of Patients Eligible for EPCLUSA Treatment

Eligibility for EPCLUSA treatment within 12 months of lung transplant

Time frame:
within 12 months of lung transplant
Reported as:
Count of participants · Participants
Number of Patients Eligible for EPCLUSA Treatment
ParticipantsEpclusa
Number of Patients Eligible for EPCLUSA Treatment1
SecondaryChange in Serum HCV RNA Levels

Serum HCV RNA levels at 12-, 24-, and 48-weeks after initiation of EPCLUSA

Time frame:
12, 24, and 48 weeks after initiation of EPCLUSA
Reported as:
Number · IU/mL
Change in Serum HCV RNA Levels
IU/mLEpclusa
Week 12NA
Week 24NA
Week 48NA
SecondaryNumber of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy

Adverse events requiring temporary interruption in EPCLUSA therapy

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy
ParticipantsEpclusa
Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy0
SecondaryPatient Survival

90-day post transplant patient survival

Time frame:
90 days post-transplant
Reported as:
Count of participants · Participants
Patient Survival
ParticipantsEpclusa
Patient Survival1
SecondaryPatient Survival

1 year post transplant patient survival

Time frame:
1 year post-tranplant
Reported as:
Count of participants · Participants
Patient Survival
ParticipantsEpclusa
Patient Survival1
SecondaryPatient Survival

90-day post transplant patient survival in recipients of HCV NAT positive donor organ

Time frame:
90 days post-transplant
Reported as:
Count of participants · Participants
Patient Survival
ParticipantsEpclusa
Patient Survival1
SecondaryPatient Survival

1 year post transplant patient survival in recipients of HCV NAT positive donor organ

Time frame:
1 year post-transplant
Reported as:
Count of participants · Participants
Patient Survival
ParticipantsEpclusa
Patient Survival1

Adverse events

Collected over 11 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Epclusa0/1 (0%)0/1 (0%)0/1 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Epclusa
<=18 years0
Between 18 and 65 years1
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Epclusa
Female0
Male1
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Epclusa
Hispanic or Latino0
Not Hispanic or Latino1
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Epclusa
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White0
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Epclusa
United States1
08

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 10, 2018
  • Informed consent form · Aug 28, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03207399
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Jul 2, 2017
Start date
Sep 15, 2017
Primary completion
Mar 25, 2019
Completion
Mar 25, 2019
Results posted
Sep 11, 2019
Last update
Sep 11, 2019

Study contacts

Omar Mohamedaly, MD
principal investigator · Duke Heath

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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