Trial Outcomes & Findings for Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment (NCT NCT03207399)

NCT ID: NCT03207399

Last Updated: 2019-09-11

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 1 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2019-09-11

Participant Flow

Participant milestones

Measure	Epclusa 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 Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

Baseline characteristics by cohort

Measure	Epclusa n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

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

Outcome measures

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

PRIMARY outcome

Timeframe: 1 year

Adverse events resulting in discontinuation of EPCLUSA

Outcome measures

Measure	Epclusa n=1 Participants 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.
Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA	0 Participants

PRIMARY outcome

Timeframe: within 12 months of lung transplant

Eligibility for EPCLUSA treatment within 12 months of lung transplant

Outcome measures

Measure	Epclusa n=1 Participants 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.
Number of Patients Eligible for EPCLUSA Treatment	1 Participants

SECONDARY outcome

Timeframe: 12, 24, and 48 weeks after initiation of EPCLUSA

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

Outcome measures

Measure	Epclusa n=1 Participants 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.
Change in Serum HCV RNA Levels Week 12	NA IU/mL HCV RNA value fell below the level of detection.
Change in Serum HCV RNA Levels Week 24	NA IU/mL HCV RNA value fell below the level of detection.
Change in Serum HCV RNA Levels Week 48	NA IU/mL HCV RNA value fell below the level of detection.

SECONDARY outcome

Timeframe: 1 year

Adverse events requiring temporary interruption in EPCLUSA therapy

Outcome measures

Measure	Epclusa n=1 Participants 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.
Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy	0 Participants

SECONDARY outcome

Timeframe: 90 days post-transplant

90-day post transplant patient survival

Outcome measures

Measure	Epclusa n=1 Participants 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.
Patient Survival	1 Participants

SECONDARY outcome

Timeframe: 1 year post-tranplant

1 year post transplant patient survival

Outcome measures

Measure	Epclusa n=1 Participants 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.
Patient Survival	1 Participants

SECONDARY outcome

Timeframe: 90 days post-transplant

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

Outcome measures

Measure	Epclusa n=1 Participants 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.
Patient Survival	1 Participants

SECONDARY outcome

Timeframe: 1 year post-transplant

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

Outcome measures

Measure	Epclusa n=1 Participants 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.
Patient Survival	1 Participants

Adverse Events

Epclusa

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Omar Mohamedaly

Duke University Medical Center

Phone: 919-684-4589

Email: omar.mohamedaly@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place