| Trial ID: | L0724 |
| Source ID: | NCT02743897
|
| Associated Drug: |
Zepatier
|
| Title: |
Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients
|
| Acronym: |
THINKER
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02743897/results
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: Zepatier|DRUG: Mavyret
|
| Outcome Measures: |
Primary: Number of Subjects Cured, Subjects with post-treatment sustained virologic response (SVR) = Number of subjects with negative HCV RNA 12 weeks after completing therapy / number of subjects treated post-kidney transplantation, Baseline to 24 weeks|Number of Subjects With SAE Attributable to HCV Therapy, Number of subjects with major adverse events attributable to HCV therapy in post-kidney transplant, Baseline to 52 weeks |
|
| Sponsor/Collaborators: |
Sponsor: University of Pennsylvania | Collaborators: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
62
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-05-01
|
| Completion Date: |
2022-12
|
| Results First Posted: |
2023-06-15
|
| Last Update Posted: |
2023-06-15
|
| Locations: |
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02743897
|
