Stem Cell Transplant Complications Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Trial of the Safety, Tolerability, and Efficacy of RV521 in the Treatment of Adult Subjects Who Have Undergone Hematopoietic Cell Transplantation (HCT) With a Documented Upper Respiratory Tract Infection (URTI) With Respiratory Syncytial Virus (RSV)
RV521 is to being developed to treat RSV infection and disease in susceptible individuals at high risk for complications. This is an international, multicenter, placebo-controlled study. Eligible subjects are adults with a documented symptomatic RSV infection who have undergone HCT transplantation and are moderately to severely immunocompromised. Qualified subjects will be randomized in a 1:1 ratio to receive RV521 or placebo, twice daily for 10 days.
The purpose of this study is to compare the viral load, safety, tolerability, and clinical efficacy of RV521 compared to placebo. This is a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled study. Up to 200 adult subjects with a documented symptomatic RSV URTI who have undergone HCT within 1 year of randomization and who are moderately to severely immunocompromised will be randomized. Qualified subjects will be randomized in a 1:1 ratio to receive RV521 capsules or matching placebo twice daily for 10 days. After the completion of the 10-day double-blind treatment period, subjects will be followed for an additional 28 days. Study drug may be taken on an outpatient or inpatient basis, depending on clinical status and site practices. Randomization will be stratified by type of HCT graft and ALC count. There are 9 clinic visits planned for this study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03482154 -
Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
|
||
| Recruiting |
NCT06080490 -
Tacrolimus Blood Concentration and Transplant-related Outcomes in Pediatric HSCT Recipients
|
||
| Completed |
NCT03042676 -
Electronic Database for the Follow up of the ATG_FamilyStudy
|
||
| Recruiting |
NCT03871296 -
DNA Methylation in Allogeneic Hematopoietic Stem Cell Transplantation.
|
||
| Not yet recruiting |
NCT06022445 -
Prospective Validation of CARPET Prognostic Model for Septic Shock After Allo-HSCT
|
||
| Recruiting |
NCT04502628 -
Hyperbaric Oxygen Therapy for Hemorrhagic Cystitis Post HSCT
|
N/A | |
| Recruiting |
NCT03793517 -
Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT
|
Phase 2/Phase 3 | |
| Completed |
NCT03454568 -
The Patients' Experience After Stem Cell Transplant
|
||
| Recruiting |
NCT05466201 -
The Use of Eltrombopag Post HSCT in BMFS
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT04080622 -
Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.
|
Phase 3 | |
| Recruiting |
NCT05523336 -
Pro-ADM vs PCT in Patients With Complications Post Hematopoietic Stem Cell Transplantation
|
||
| Completed |
NCT03355235 -
Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant
|
||
| Completed |
NCT04888286 -
DSAs in Patients Undergoing Allo-HSCT From Mismatched Donors
|
||
| Not yet recruiting |
NCT05421416 -
Loratadine for the Prevention of G-CSF-related Bone Pain
|
Phase 2 | |
| Recruiting |
NCT04167683 -
Muscle Dysfunction in Patients With Hematological Diseases Referred to Stem Cell Transplant
|
||
| Active, not recruiting |
NCT03967665 -
Risk Stratification-directed NAC for Prevention of Poor Hematopoietic Reconstitution
|
Phase 3 | |
| Withdrawn |
NCT05104268 -
Study of a New Medical Device for Oral Mucositis
|
Early Phase 1 | |
| Recruiting |
NCT04623424 -
Intestinal Microbiota in Stem Cell Transplant Transplant Admission
|
||
| Active, not recruiting |
NCT04669210 -
PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT
|
Phase 2 | |
| Completed |
NCT03489551 -
Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
|
Phase 4 |