| Trial ID: | L1296 |
| Source ID: | NCT02781649
|
| Associated Drug: |
Zepatier
|
| Title: |
Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients
|
| Acronym: |
EXPANDER-1
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02781649/results
|
| Conditions: |
End-Stage Renal Disease|Hepatitis C
|
| Interventions: |
DRUG: Zepatier|DRUG: Ribavirin|DRUG: Sofosbuvir
|
| Outcome Measures: |
Primary: 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, 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., 12 weeks after transplant | Secondary: Viral Response, 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, 12 weeks after completing treatment|Antibody Development, Number of kidney transplant recipients who become reactive for HCV antibody, 12 weeks|Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Mutations in the HCV Population From the Deceased Donors, Number of participants with NS5A resistance mutations in the HCV population from the deceased donors. Number of donors with NS5A resistance mutations, Baseline|IP-10 Elevations, Measurement of interferon (IFN)-gamma inducible protein 10 (IP-10) a marker of acute hepatitis C infection., 12 weeks|Kidney Function at 6 Months, Serum creatinine mg/dL at 6 months following transplantation, 6 months following transplantation|Kidney Function at 12 Months, Serum creatinine mg/dL at 12 months following transplantation, 12 months following transplantation
|
| Sponsor/Collaborators: |
Sponsor: Johns Hopkins University | Collaborators: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
10
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-07-20
|
| Completion Date: |
2018-01-01
|
| Results First Posted: |
2018-04-05
|
| Last Update Posted: |
2018-09-06
|
| Locations: |
Johns Hopkins Hospital, Baltimore, Maryland, 21205, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02781649
|
