Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-01-08 @ 5:06 PM
Study NCT ID:
NCT03279133
Status:
WITHDRAWN
Last Update Posted:
2018-08-31
First Post:
2017-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ledipasvir/Sofosbuvir Treatment for Hepatitis C in HCT Recipients.
Sponsor:
Kaiser Permanente
Organization:
Study Overview
Official Title:
A Pilot/Feasibility Study of Ledipasvir/Sofosbuvir as Treatment for Hepatitis C in Hematopoietic Cell Transplantation (HCT) Recipients.
Status:
WITHDRAWN
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to find eligible patients with untreated hepatitis C virus.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The prevalence of Hepatitis C Virus (HCV) infection was reported to range between 10% and up to 30% prior to institution of routine HCV screening in recipients of HCT (hematopoietic cell transplantation). In an Italian prospective study 6% of HCT candidates were positive for HCV RNA. HCV in recipients of HCT carries both short-term and long-term consequences. In the short-term those with HCV after hematopoietic cell transplantation have been associated with risk for sinusoidal obstruction syndrome especially in patients with some level of hepatic dysfunction going in to the transplant. In addition, the type of conditioning chemotherapy (e.g., busulfan) and radiation may increase risk for sinusoidal obstruction syndrome. The rate of hematopoietic recovery was found to be lower in HCV infected recipients, with delayed neutrophil and platelet engraftment.
In the long-term, HCV may flare up once immunosuppression is being tapered off. The issue of reactivation of viral hepatitis (HBV and HCV) after HCT has been well documented. The risk for HCV reactivation in allogenic HCT in one study was reported at 100% by 12 months after HCT, with risk for death related to HCV of 8%. Also, of concern is rapid progression of liver disease in long-term survivors of HCV+ HCT. In such patients, cumulative incidence of cirrhosis has been reported in up to 11% and 24% at 15 and 20 years after HCT respectively.
Hepatitis C infection is associated with significant morbidity and mortality, due to the short-term and long-term complications associated with it. Treatment of hepatitis C virus with direct-acting antiviral (DAA) agents pre-hematopoietic cell transplantation (HCT) in candidates with hepatitis C may lead to reduction of both short-term and long-term complications from it.
Treatment with DAA's pre-HCT in candidates with hepatitis C would potentially prevent complications of hepatitis C infection; prevent reactivation of hepatitis C post-HCT, prevent delay in hematopoietic recovery (especially neutrophils and platelet), possibly reduce risk for sinsusoidal obstruction syndrome, prevent relapse of malignancy that could be related to hepatitis C (non-Hodgkin lymphoma), reduce non-relapse mortality and long-term complications (cirrhosis).
In the long-term, HCV may flare up once immunosuppression is being tapered off. The issue of reactivation of viral hepatitis (HBV and HCV) after HCT has been well documented. The risk for HCV reactivation in allogenic HCT in one study was reported at 100% by 12 months after HCT, with risk for death related to HCV of 8%. Also, of concern is rapid progression of liver disease in long-term survivors of HCV+ HCT. In such patients, cumulative incidence of cirrhosis has been reported in up to 11% and 24% at 15 and 20 years after HCT respectively.
Hepatitis C infection is associated with significant morbidity and mortality, due to the short-term and long-term complications associated with it. Treatment of hepatitis C virus with direct-acting antiviral (DAA) agents pre-hematopoietic cell transplantation (HCT) in candidates with hepatitis C may lead to reduction of both short-term and long-term complications from it.
Treatment with DAA's pre-HCT in candidates with hepatitis C would potentially prevent complications of hepatitis C infection; prevent reactivation of hepatitis C post-HCT, prevent delay in hematopoietic recovery (especially neutrophils and platelet), possibly reduce risk for sinsusoidal obstruction syndrome, prevent relapse of malignancy that could be related to hepatitis C (non-Hodgkin lymphoma), reduce non-relapse mortality and long-term complications (cirrhosis).
Detailed Description:
This is an open-label observational/ feasibility study to treat candidates for HCT infected with hepatitis C prior to the transplantation to reduce the complications associated with hepatitis C in the post-transplant setting.
The study will be conducted at Kaiser Permanente Los Angeles Medical Center and City of Hope National Medical Center, Duarte, CA.
There is no data available on the outcomes of treating hepatitis C with DAA's pre-HCT in candidates with hepatitis C infection. The ASBMT task force made recommendation to consider treating hepatitis C infection pre-HCT based on potential benefits it may be associated with. A single case report has documented benefit of treating a donor infected with hepatitis C prior to stem cell collection with DAA and ribavirin
Subject Population will include autologous or allogeneic HCT candidates (for hematologic malignancy) who have hepatitis C infection. Subjects will be considered treatment-experienced if they have received prior interferon-based therapy. Treatment-experienced patients with prior use of DAA(s) are excluded from study participation.
This study will treat HCV patients prior to HCT, with the goal of reducing early post HCT complications in the first 100 days post HCT followed by measuring outcomes at 2 years post HCT.
Subjects will receive LDV 90mg/SOF 400mg FDC for 12 weeks.
The study will be conducted at Kaiser Permanente Los Angeles Medical Center and City of Hope National Medical Center, Duarte, CA.
There is no data available on the outcomes of treating hepatitis C with DAA's pre-HCT in candidates with hepatitis C infection. The ASBMT task force made recommendation to consider treating hepatitis C infection pre-HCT based on potential benefits it may be associated with. A single case report has documented benefit of treating a donor infected with hepatitis C prior to stem cell collection with DAA and ribavirin
Subject Population will include autologous or allogeneic HCT candidates (for hematologic malignancy) who have hepatitis C infection. Subjects will be considered treatment-experienced if they have received prior interferon-based therapy. Treatment-experienced patients with prior use of DAA(s) are excluded from study participation.
This study will treat HCV patients prior to HCT, with the goal of reducing early post HCT complications in the first 100 days post HCT followed by measuring outcomes at 2 years post HCT.
Subjects will receive LDV 90mg/SOF 400mg FDC for 12 weeks.
Study Oversight
Has Oversight DMC:
False
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?: