Ignite Creation Date:
2024-05-06 @ 9:06 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02902120
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2016-08-19
Brief Title:
HCV Treatment Immune Response With GrazoprevirElbasvir Before or After Renal Transplant
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Host Mechanisms Involved in Achieving SVR Using Grazoprevir and Elbasvir in Treatment of Chronic Hepatitis C in Patients With CKD Before and After Renal Transplantation
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether patients treated for chronic hepatitis C HCV with zepatier grazoprevirelbasvir prior to kidney transplant will have a stronger immune response compared to patients treated after kidney transplant 25 patients with chronic kidney disease CKD and HCV will be treated with zepatier and 25 kidney transplant recipients with chronic kidney disease will be treated with zepatier Blood markers of immune function will be monitored in both groups to determine their response to therapy
Detailed Description:
The study will be a pilot prospective single-center open-label non-randomized non-controlled parallel clinical trial 25 HCV genotype 1 infected patients post transplant will be enrolled in the study Recruitment will be conducted through the renal transplant and nephrology outpatient clinics at the University of Maryland
The post-transplant cohort will include renal transplant recipients of both living donor and deceased donor organs infected with HCV prior to their transplantation with GFRs 50 with active HCV viremia These patients will be recruited from the University of Marylands multidisciplinary transplant nephrology clinic or infectious disease clinic
Screening All patients will be screened at the Institute of Human Virology IHV Clinical Research Unit At this visit all patients will have screening labs drawn and a history and physical examination performed Additional requirements will be genotype testing prior to enrollment but after transplant and disease staging within 12 months of enrollment by liver biopsy elastography or biochemical testing For those who do not have a genotype or disease staging within the specified time frame genotyping and elastography will be repeated as part of the study screening work up Eligibility will be determined based upon these results within 6 weeks of starting the study drugs
Given the reduced efficacy of this regimen in patients with genotype 1a with the presence of baseline NS5A resistance-associated variants RAVs the investigators will screen patients for RAVs in patients with HCV genotype 1a at the time of enrollment Any patient with genotype 1a HCV found to have NS5A RAVs will undergo 16 weeks of therapy according to current treatment guidelines
Starting therapy Study drugs will be administered starting on day 0 after a history and physical examination is performed and safety labs are checked All patients will sign an informed consent as approved by our Institutional Review Board IRB prior to administration of study drugs
Study visits during treatment Patients will be followed every 4 weeks while they are receiving study drugs HCV viral load VL safety labs and hepatic panel will be performed at each of these visits Patients will also be advised about study adherence and monitored for adverse events
Safety and adverse event monitoring At each study visit research nurses will inquire about adverse events that may or may not be related to study drugs Any unfavorable medical occurrences will be recorded whether or not considered related to the patients participation in the research temporally associated with the patients participation in the research Adverse events AEs classified as grade 3 or higher will be reported to the IRB and principal investigator Any grade 3 or 4 AEs and all serious adverse events SAEs will be reviewed as they occur by the study team
Safety labs will also be drawn at these visits Levels of immunosuppressive agents will also be determined at these visits as appropriate The need for dose modification of the patients immunosuppression in the time between visits will be recorded
End of treatment visit Patients will be seen 12 weeks after starting study drugs or 16 weeks in the case of genotype 1a patients with baseline NS5A RAVs for an end of study visit HCV VL safety labs and hepatic panel will be performed at this visit Patients will also be counseled about study adherence and the investigators will inquire about adverse events
Post treatment follow up visits Patients will be followed every 4 weeks for 12 weeks after they complete treatment HCV VL safety labs and a hepatic panel will be performed at these visits
The post-transplant cohort will include renal transplant recipients of both living donor and deceased donor organs infected with HCV prior to their transplantation with GFRs 50 with active HCV viremia These patients will be recruited from the University of Marylands multidisciplinary transplant nephrology clinic or infectious disease clinic
Screening All patients will be screened at the Institute of Human Virology IHV Clinical Research Unit At this visit all patients will have screening labs drawn and a history and physical examination performed Additional requirements will be genotype testing prior to enrollment but after transplant and disease staging within 12 months of enrollment by liver biopsy elastography or biochemical testing For those who do not have a genotype or disease staging within the specified time frame genotyping and elastography will be repeated as part of the study screening work up Eligibility will be determined based upon these results within 6 weeks of starting the study drugs
Given the reduced efficacy of this regimen in patients with genotype 1a with the presence of baseline NS5A resistance-associated variants RAVs the investigators will screen patients for RAVs in patients with HCV genotype 1a at the time of enrollment Any patient with genotype 1a HCV found to have NS5A RAVs will undergo 16 weeks of therapy according to current treatment guidelines
Starting therapy Study drugs will be administered starting on day 0 after a history and physical examination is performed and safety labs are checked All patients will sign an informed consent as approved by our Institutional Review Board IRB prior to administration of study drugs
Study visits during treatment Patients will be followed every 4 weeks while they are receiving study drugs HCV viral load VL safety labs and hepatic panel will be performed at each of these visits Patients will also be advised about study adherence and monitored for adverse events
Safety and adverse event monitoring At each study visit research nurses will inquire about adverse events that may or may not be related to study drugs Any unfavorable medical occurrences will be recorded whether or not considered related to the patients participation in the research temporally associated with the patients participation in the research Adverse events AEs classified as grade 3 or higher will be reported to the IRB and principal investigator Any grade 3 or 4 AEs and all serious adverse events SAEs will be reviewed as they occur by the study team
Safety labs will also be drawn at these visits Levels of immunosuppressive agents will also be determined at these visits as appropriate The need for dose modification of the patients immunosuppression in the time between visits will be recorded
End of treatment visit Patients will be seen 12 weeks after starting study drugs or 16 weeks in the case of genotype 1a patients with baseline NS5A RAVs for an end of study visit HCV VL safety labs and hepatic panel will be performed at this visit Patients will also be counseled about study adherence and the investigators will inquire about adverse events
Post treatment follow up visits Patients will be followed every 4 weeks for 12 weeks after they complete treatment HCV VL safety labs and a hepatic panel will be performed at these visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None