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Clinical Trial Details

Trial ID: L1280
Source ID: NCT03627299
Associated Drug: 300mg Glecaprevir/Pibrentasivir 120mg
Title: Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03627299/results
Conditions: End Stage Renal Disease|Hepatitis C
Interventions: DRUG: 300mg glecaprevir/pibrentasivir 120mg
Outcome Measures: Primary: Viral Response at Week 12, 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 therapy|Number of Participants With Grade 3 or Higher Treatment-related Adverse Events Related to the Use of G-P, 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., 4 weeks after transplant | Secondary: Viral Response at 1 Week, This is the number of participants with undetectable hepatitis C RNA in the blood at 1 week after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 1, 1 week after completing therapy|Viral Response at 2 Weeks, This is the number of participants with undetectable hepatitis C RNA in the blood at 2 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 2, 2 weeks after completing therapy|Viral Response at 4 Weeks, This is the number of participants with undetectable hepatitis C RNA in the blood at 4 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 4, 4 weeks after completing therapy|Viral Response at 8 Weeks, This is the number of participants with undetectable hepatitis C RNA in the blood at 8 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 8, 8 weeks after completing therapy|Antibody Development, Number of kidney transplant recipients that become reactive for HCV antibody, week 12 after discontinuation of therapy|T-cell Response at Baseline, Measurement of t-cell response to HCV peptides, a marker of acute hepatitis C infection. This categorizes participants into no T-cell response, T-cell response to 1 peptide, T-cell response to 2 peptides and T-cell response to 3 peptides., Baseline prior to induction therapy|T-cell Response at 12 Weeks, Measurement of t-cell response to HCV peptides, a marker of acute hepatitis C infection. This categorizes participants into no T-cell response, T-cell response to 1 peptide, T-cell response to 2 peptides and T-cell response to 3 peptides., Week12 after discontinuation of therapy|Kidney Function at 6 Months, Serum creatinine mg/dL at 6 months following transplantation, 6 months following transplant|Kidney Function at 12 Months, Serum creatinine mg/dL at 12 months following transplantation, 12 months following transplant
Sponsor/Collaborators: Sponsor: Johns Hopkins University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 11
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-09-25
Completion Date: 2021-09-20
Results First Posted: 2020-08-24
Last Update Posted: 2021-10-19
Locations: Johns Hopkins University, Baltimore, Maryland, 21205, United States
URL: https://clinicaltrials.gov/show/NCT03627299