Trial Outcomes & Findings for Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients (NCT NCT02781649)
NCT ID: NCT02781649
Last Updated: 2018-09-06
Results Overview
Proportion of participants with grade 3 or higher treatment-related adverse events (AE) as assessed by US Department of Health and Human Services Common Terminology of AEs version 4. An AE is an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5. Grade 3 Severe or medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. The investigator will determine if the AE is related to the treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
12 weeks after transplant
Results posted on
2018-09-06
Participant Flow
Participant milestones
| Measure |
Donor Genotype 1a no Resistance or 1b
Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
|
Donor Genotype 1a With Resistance
Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Ribavirin: Ribavirin 1200 mg/d (\> 75 kg) or 1000 mg/d (\< 75 kg) by mouth daily in two divided doses
|
Donor Genotype 2 or 3
Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Sofosbuvir: Sofosbuvir 400 mg daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
0
|
3
|
|
Overall Study
COMPLETED
|
7
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients
Baseline characteristics by cohort
| Measure |
Donor Genotype 1a no Resistance or 1b
n=7 Participants
Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
|
Donor Genotype 1a With Resistance
Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Ribavirin: Ribavirin 1200 mg/d (\> 75 kg) or 1000 mg/d (\< 75 kg) by mouth daily in two divided doses
|
Donor Genotype 2 or 3
n=3 Participants
Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Sofosbuvir: Sofosbuvir 400 mg daily
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Age, Continuous
|
71 years
n=99 Participants
|
—
|
61 years
n=206 Participants
|
71 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
—
|
3 participants
n=206 Participants
|
10 participants
n=7 Participants
|
|
Hepatitis C virus (HCV) antibody negative
|
7 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after transplantPopulation: There were no participants who received donors found to have hepatitis C genotype 1a with resistance enrolled.
Proportion of participants with grade 3 or higher treatment-related adverse events (AE) as assessed by US Department of Health and Human Services Common Terminology of AEs version 4. An AE is an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5. Grade 3 Severe or medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. The investigator will determine if the AE is related to the treatment.
Outcome measures
| Measure |
Donor Genotype 1a no Resistance or 1b
n=7 Participants
Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
|
Donor Genotype 1a With Resistance
Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Ribavirin: Ribavirin 1200 mg/d (\> 75 kg) or 1000 mg/d (\< 75 kg) by mouth daily in two divided doses
|
Donor Genotype 2 or 3
n=3 Participants
Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Sofosbuvir: Sofosbuvir 400 mg daily
|
|---|---|---|---|
|
Number of Participants With Grade 3 or Higher Treatment-related Adverse Events as US Department of Health and Human Services Common Terminology of Adverse Events (CTCAE) Version 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after completing treatmentPopulation: There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.
This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 12
Outcome measures
| Measure |
Donor Genotype 1a no Resistance or 1b
n=7 Participants
Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
|
Donor Genotype 1a With Resistance
Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Ribavirin: Ribavirin 1200 mg/d (\> 75 kg) or 1000 mg/d (\< 75 kg) by mouth daily in two divided doses
|
Donor Genotype 2 or 3
n=3 Participants
Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Sofosbuvir: Sofosbuvir 400 mg daily
|
|---|---|---|---|
|
Viral Response
|
7 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.
Number of kidney transplant recipients who become reactive for HCV antibody
Outcome measures
| Measure |
Donor Genotype 1a no Resistance or 1b
n=7 Participants
Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
|
Donor Genotype 1a With Resistance
Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Ribavirin: Ribavirin 1200 mg/d (\> 75 kg) or 1000 mg/d (\< 75 kg) by mouth daily in two divided doses
|
Donor Genotype 2 or 3
n=3 Participants
Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Sofosbuvir: Sofosbuvir 400 mg daily
|
|---|---|---|---|
|
Antibody Development
|
3 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.
Number of participants with NS5A resistance mutations in the HCV population from the deceased donors. Number of donors with NS5A resistance mutations
Outcome measures
| Measure |
Donor Genotype 1a no Resistance or 1b
n=7 Participants
Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
|
Donor Genotype 1a With Resistance
Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Ribavirin: Ribavirin 1200 mg/d (\> 75 kg) or 1000 mg/d (\< 75 kg) by mouth daily in two divided doses
|
Donor Genotype 2 or 3
n=3 Participants
Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Sofosbuvir: Sofosbuvir 400 mg daily
|
|---|---|---|---|
|
Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Mutations in the HCV Population From the Deceased Donors
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data were not collected
Measurement of interferon (IFN)-gamma inducible protein 10 (IP-10) a marker of acute hepatitis C infection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months following transplantationPopulation: There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.
Serum creatinine mg/dL at 6 months following transplantation
Outcome measures
| Measure |
Donor Genotype 1a no Resistance or 1b
n=7 Participants
Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
|
Donor Genotype 1a With Resistance
Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Ribavirin: Ribavirin 1200 mg/d (\> 75 kg) or 1000 mg/d (\< 75 kg) by mouth daily in two divided doses
|
Donor Genotype 2 or 3
n=3 Participants
Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Sofosbuvir: Sofosbuvir 400 mg daily
|
|---|---|---|---|
|
Kidney Function at 6 Months
|
1.12 mg/dL
Interval 1.06 to 1.7
|
—
|
0.9 mg/dL
Interval 0.9 to 1.0
|
SECONDARY outcome
Timeframe: 12 months following transplantationPopulation: There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.
Serum creatinine mg/dL at 12 months following transplantation
Outcome measures
| Measure |
Donor Genotype 1a no Resistance or 1b
n=7 Participants
Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
|
Donor Genotype 1a With Resistance
Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Ribavirin: Ribavirin 1200 mg/d (\> 75 kg) or 1000 mg/d (\< 75 kg) by mouth daily in two divided doses
|
Donor Genotype 2 or 3
n=3 Participants
Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Sofosbuvir: Sofosbuvir 400 mg daily
|
|---|---|---|---|
|
Kidney Function at 12 Months
|
1.0 mg/dL
Interval 0.9 to 1.0
|
—
|
1.3 mg/dL
Interval 1.0 to 2.0
|
Adverse Events
Donor Genotype 1a no Resistance or 1b
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Donor Genotype 1a With Resistance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Donor Genotype 2 or 3
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Donor Genotype 1a no Resistance or 1b
n=7 participants at risk
Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
|
Donor Genotype 1a With Resistance
Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Ribavirin: Ribavirin 1200 mg/d (\> 75 kg) or 1000 mg/d (\< 75 kg) by mouth daily in two divided doses
|
Donor Genotype 2 or 3
n=3 participants at risk
Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks
Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
Sofosbuvir: Sofosbuvir 400 mg daily
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulomonary infection
|
0.00%
0/7 • Adverse events were collected for 6 months from initiation of treatment
10 patients overall were at risk of adverse events, none of them from the Donor Genotype 1a With Resistance arm
|
—
0/0 • Adverse events were collected for 6 months from initiation of treatment
10 patients overall were at risk of adverse events, none of them from the Donor Genotype 1a With Resistance arm
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for 6 months from initiation of treatment
10 patients overall were at risk of adverse events, none of them from the Donor Genotype 1a With Resistance arm
|
|
Renal and urinary disorders
Urinary tract infection
|
28.6%
2/7 • Number of events 2 • Adverse events were collected for 6 months from initiation of treatment
10 patients overall were at risk of adverse events, none of them from the Donor Genotype 1a With Resistance arm
|
—
0/0 • Adverse events were collected for 6 months from initiation of treatment
10 patients overall were at risk of adverse events, none of them from the Donor Genotype 1a With Resistance arm
|
0.00%
0/3 • Adverse events were collected for 6 months from initiation of treatment
10 patients overall were at risk of adverse events, none of them from the Donor Genotype 1a With Resistance arm
|
|
Blood and lymphatic system disorders
blood stream infection
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for 6 months from initiation of treatment
10 patients overall were at risk of adverse events, none of them from the Donor Genotype 1a With Resistance arm
|
—
0/0 • Adverse events were collected for 6 months from initiation of treatment
10 patients overall were at risk of adverse events, none of them from the Donor Genotype 1a With Resistance arm
|
0.00%
0/3 • Adverse events were collected for 6 months from initiation of treatment
10 patients overall were at risk of adverse events, none of them from the Donor Genotype 1a With Resistance arm
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place