Trial Outcomes & Findings for DAA Treatment in Donor HCV-positive to Recipient HCV-negative Heart Transplant (NCT NCT03208244)

NCT ID: NCT03208244

Last Updated: 2022-06-22

Results Overview

Negative HCV viral RNA at 12 weeks after the last dose of treatment.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 12 weeks post treatment
• Results posted on: 2022-06-22

Participant Flow

Recruitment occurred between 11/2017 and 4/1/2021

7 participants received transplant with an HCV NAT negative organ and did not meet protocol criteria for DAA treatment.

Participant milestones

Measure	Treatment With Direct Acting Antiviral for HCV 12 weeks of treatment with HCV Direct Acting Antiviral tablet Clinically prescribed direct acting antiviral: HCV treatment for 12 weeks
Overall Study STARTED	33
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Treatment With Direct Acting Antiviral for HCV 12 weeks of treatment with HCV Direct Acting Antiviral tablet Clinically prescribed direct acting antiviral: HCV treatment for 12 weeks
Overall Study Death	1

Baseline Characteristics

DAA Treatment in Donor HCV-positive to Recipient HCV-negative Heart Transplant

Baseline characteristics by cohort

Measure	Treatment With Direct Acting Antiviral for HCV n=33 Participants 12 weeks of treatment with HCV Direct Acting Antiviral tablet Clinically prescribed direct acting antiviral: HCV treatment for 12 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	3 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks post treatment

Population: number of subjects active on study at 12 weeks post DAA treatment

Negative HCV viral RNA at 12 weeks after the last dose of treatment.

Outcome measures

Measure	Treatment With Direct Acting Antiviral for HCV n=30 Participants 12 weeks of treatment with HCV Direct Acting Antiviral tablet Clinically prescribed direct acting antiviral: HCV treatment for 12 weeks
Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment	30 Participants

SECONDARY outcome

Timeframe: 12 weeks

Safety and tolerablity of commercially available DAA therapy in the cardiac transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating out of range laboratory results as compared to baseline/pretreatment values per patient.

Outcome measures

Measure	Treatment With Direct Acting Antiviral for HCV n=33 Participants 12 weeks of treatment with HCV Direct Acting Antiviral tablet Clinically prescribed direct acting antiviral: HCV treatment for 12 weeks
Number of Participants With Adverse Events and Clinically Significant Out of Range Lab Values of DAA Therapy in Patients Undergoing Cardiac Transplantation	0 Participants

Adverse Events

Treatment With Direct Acting Antiviral for HCV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raymond Chung, MD

Massachusetts General Hospital

Phone: 617-724-7562

Email: Chung.Raymond@mgh.harvard.edu

Results disclosure agreements

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