Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03207399
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Actual Duration (Months): 18.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic; Lung Transplant	Drug: Epclusa	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment: A Pilot Feasibility and Efficacy Study
• Actual Study Start Date: Sep 15, 2017
• Actual Primary Completion Date: Mar 25, 2019
• Actual Study Completion Date: Mar 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Epclusa Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.	Drug: Epclusa; Patients will be treated with this drug for 12 weeks post lung transplant.

Outcome Measures

Primary Outcome Measures

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

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

2. Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA [1 year]

   Adverse events resulting in discontinuation of EPCLUSA

3. Number of Patients Eligible for EPCLUSA Treatment [within 12 months of lung transplant]

   Eligibility for EPCLUSA treatment within 12 months of lung transplant

Secondary Outcome Measures

1. Change in Serum HCV RNA Levels [12, 24, and 48 weeks after initiation of EPCLUSA]

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

2. Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy [1 year]

   Adverse events requiring temporary interruption in EPCLUSA therapy

3. Patient Survival [90 days post-transplant]

   90-day post transplant patient survival

4. Patient Survival [1 year post-tranplant]

   1 year post transplant patient survival

5. Patient Survival [90 days post-transplant]

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

6. Patient Survival [1 year post-transplant]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Omar Mohamedaly, MD, Duke Heath

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 10, 2018
• Informed Consent Form - Aug 28, 2018

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03207399
• Other Study ID Numbers: Pro00074361
• First Posted: Jul 2, 2017
• Last Update Posted: Sep 11, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Hepatitis C; Hepatitis C, Chronic; Sofosbuvir-velpatasvir drug combination

Study Results

Participant Flow

Arm/Group Title	Epclusa
Arm/Group Description	Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant.
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Epclusa
Arm/Group Description	Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant.
Overall Participants	1
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	1 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	1 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 100%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	1 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.
Description	Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epclusa
Arm/Group Description	Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant.
Measure Participants	1
Count of Participants [Participants]	1 100%

2. Primary Outcome

Title	Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA
Description	Adverse events resulting in discontinuation of EPCLUSA
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epclusa
Arm/Group Description	Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant.
Measure Participants	1
Count of Participants [Participants]	0 0%

3. Primary Outcome

Title	Number of Patients Eligible for EPCLUSA Treatment
Description	Eligibility for EPCLUSA treatment within 12 months of lung transplant
Time Frame	within 12 months of lung transplant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epclusa
Arm/Group Description	Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant.
Measure Participants	1
Count of Participants [Participants]	1 100%

4. Secondary Outcome

Title	Change in Serum HCV RNA Levels
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epclusa
Arm/Group Description	Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant.
Measure Participants	1
Week 12	NA
Week 24	NA
Week 48	NA

5. Secondary Outcome

Title	Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy
Description	Adverse events requiring temporary interruption in EPCLUSA therapy
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epclusa
Arm/Group Description	Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant.
Measure Participants	1
Count of Participants [Participants]	0 0%

6. Secondary Outcome

Title	Patient Survival
Description	90-day post transplant patient survival
Time Frame	90 days post-transplant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epclusa
Arm/Group Description	Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant.
Measure Participants	1
Count of Participants [Participants]	1 100%

7. Secondary Outcome

Title	Patient Survival
Description	1 year post transplant patient survival
Time Frame	1 year post-tranplant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epclusa
Arm/Group Description	Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant.
Measure Participants	1
Count of Participants [Participants]	1 100%

8. Secondary Outcome

Title	Patient Survival
Description	90-day post transplant patient survival in recipients of HCV NAT positive donor organ
Time Frame	90 days post-transplant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epclusa
Arm/Group Description	Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant.
Measure Participants	1
Count of Participants [Participants]	1 100%

9. Secondary Outcome

Title	Patient Survival
Description	1 year post transplant patient survival in recipients of HCV NAT positive donor organ
Time Frame	1 year post-transplant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epclusa
Arm/Group Description	Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant.
Measure Participants	1
Count of Participants [Participants]	1 100%

Adverse Events

Time Frame	11 months
Arm/Group Title	Epclusa
Arm/Group Description	Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant.
All Cause Mortality
	Epclusa
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Serious Adverse Events
	Epclusa
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	Epclusa
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.