Hepatitis C Infection Clinical Trial
Official title:
Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection
This study will test the safety and tolerability of HCV Entry Inhibitor ITX 5061 in Liver Transplant Recipients with Hepatitis C infection. The investigators hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and that therapy will also inhibit HCV infection of newly transplanted livers in adults with prior HCV infection.
All subjects will receive 28 days of ITX 5061 beginning at the time of transplant.
Dosing of ITX 5061 is as follows:
Day of Transplant prior to surgery: ITX 5061 300 mg Day of Transplant following surgery: ITX
5061 300 mg Post-Operative Days 1-6: ITX 5061 300 mg Post-Operative Days 7-27: ITX 5061 150
mg
Subjects will be monitored for HCV RNA levels, HDL cholesterol and ITX 5061 drug
concentration levels.
A liver biopsy will be performed at 6 months post-transplant to assess for histological signs
of HCV recurrence.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01771653 -
Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection
|
N/A | |
| Recruiting |
NCT03601546 -
Feasibility of Implementing a Cohort of People Living With Hepatitis C in Vietnam
|
||
| Completed |
NCT02362217 -
A Study to Assess the Safety of HIV and Hep C Vaccine Candidates When Given Separately or in Combination
|
Phase 1 | |
| Completed |
NCT00513461 -
Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection
|
Phase 2 | |
| Active, not recruiting |
NCT02143401 -
Navitoclax and Sorafenib Tosylate in Treating Patients With Relapsed or Refractory Solid Tumors
|
Phase 1 | |
| Completed |
NCT02247401 -
Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt
|
Phase 3 | |
| Completed |
NCT02582632 -
A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults
|
Phase 3 | |
| Terminated |
NCT01532908 -
Open Label Study of the Efficacy and Safety of MBL-HCV1 in Combination With Oral Direct-Acting Antivirals in Patients Undergoing Liver Transplantation for Hepatitis C
|
Phase 2 | |
| Recruiting |
NCT01754961 -
Effects of Vitamin D on Inflammation in Liver Disease
|
Phase 2 | |
| Terminated |
NCT01465516 -
Treating Hispanic Patients Diagnosed With Hepatitis C Using Boceprevir
|
N/A | |
| Completed |
NCT01265511 -
Study of SCY-635, Pegasys and Copegus in Hepatitis C
|
Phase 2 | |
| Completed |
NCT04042740 -
Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection
|
Phase 2 | |
| Not yet recruiting |
NCT05601518 -
Efficacy and Safety of Coblopasvir Hydrochloride Capsules Combined With Sofosbuvir Tablets for the Treatment of Chronic HCV Infection: A Prospective, Multi-center Real-world Study.
|
||
| Terminated |
NCT02429583 -
Effects of Persistent Innate Immune Activation on Vaccine Efficacy
|
Phase 4 | |
| Not yet recruiting |
NCT05506475 -
Evaluation of HCV Care and Treatment for HIV-HCV Co-infected Patients in Decentralised Areas in Vietnam
|
||
| Withdrawn |
NCT02112630 -
Boceprevir in End Stage Renal Disease (ESRD)
|
N/A | |
| Terminated |
NCT01841502 -
Interaction Between Paroxetine and Telaprevir
|
Phase 2 | |
| Completed |
NCT02076100 -
Safety, Pharmacokinetics, and Pharmacodynamics of Ruzasvir (MK-8408) in Participants With Hepatitis C Infection (MK-8408-003)
|
Phase 1 | |
| Completed |
NCT01803308 -
A Multiple Ascending Dose Phase I Study of SB 9200 in Treatment Naïve Adults With Chronic Hepatitis C Infection
|
Phase 1 | |
| Active, not recruiting |
NCT02772003 -
DNA Vaccine Therapy in Treating Patients With Chronic Hepatitis C Virus Infection
|
Phase 1 |