End Stage Heart Disease, Hepatitis C
Conditions
Keywords
Heart Disease, Heart Transplant, HCV, Hepatitis C
Brief summary
This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.
Detailed description
The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after cardiac transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor heart to an HCV naïve recipient.
Interventions
DRUGClinically prescribed direct acting antiviral
HCV treatment for 12 weeks
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Received heart transplant from HCV+ donor
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recipient is Age ≥ 18 years * Serum ALT within normal limits with no history of liver disease * Lack of sensitization (i.e. PRA \< 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection
Exclusion criteria
* Sensitization (i.e. PRA \>20%) * Any liver disease in recipient * Albumin \< 3g/dl or platelet count \< 75 x 103/mL * Need for dual organ transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment | 12 weeks post treatment | Negative HCV viral RNA at 12 weeks after the last dose of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events and Clinically Significant Out of Range Lab Values of DAA Therapy in Patients Undergoing Cardiac Transplantation | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between 11/2017 and 4/1/2021
Pre-assignment details
7 participants received transplant with an HCV NAT negative organ and did not meet protocol criteria for DAA treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Treatment With Direct Acting Antiviral for HCV |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 33 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 33 |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment
Negative HCV viral RNA at 12 weeks after the last dose of treatment.
Time frame: 12 weeks post treatment
Population: number of subjects active on study at 12 weeks post DAA treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment With Direct Acting Antiviral for HCV | Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment | 30 Participants |
Secondary
Number of Participants With Adverse Events and Clinically Significant Out of Range Lab Values of DAA Therapy in Patients Undergoing Cardiac Transplantation
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.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment With Direct Acting Antiviral for HCV | Number of Participants With Adverse Events and Clinically Significant Out of Range Lab Values of DAA Therapy in Patients Undergoing Cardiac Transplantation | 0 Participants |