Clinical trials: Bone Infection
Pharmacokinetics, Safety Issues
A Clinical Study With Adalimumab Biosimilar
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) [Test Product] vs.
- Trial name
- NCT06291948
- Testing
- Humira® (adalimumab) AC Pen [Reference Product], Adalimumab Richmond [Test Product]
- Where
- Argentina
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
Periprosthetic Joint Infections
Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities
This is a pivotal, prospective, multi-center, randomized, concurrent control, patient and assessor-blinded study with two arms: a treatment arm (where subjects will be treated with the EP Granules + Tobramycin (EP G + T)…
- Trial name
- MAGIC (NCT05361941)
- Testing
- EP Granules with Tobramycin, empty voids
- Where
- 16 sites in United States
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- Elute, Inc.
Bone and Joint Infection
InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS
Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota imbalance, host-microbiota crosstalk dysfunction and inflammation.
- Trial name
- OSIRIS (NCT03011502)
- Testing
- Biological samples collection of blood and feces
- Where
- 5 sites in France
- Volunteers
- 62 people
- Sponsor
- MaaT Pharma
Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia
Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
The purpose of this trial is to evaluate a CMV vaccine given to related donor/recipient pairs (donors prior to peripheral blood stem cell donation and CMV-seropositive recipients just before and after transplantation) and…
- Conditions
- Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Hodgkin's Lymphoma
- Trial name
- NCT00285259
- Testing
- VCL-CB01, Phosphate-buffered Saline (PBS)
- Where
- 22 sites in United States
- Volunteers
- 112 people
- Sponsor
- Astellas Pharma Inc
Solid Tumors and Hematologic Malignancy
An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment…
- Trial name
- NCT02431260
- Testing
- INCB054329 Monotherapy
- Where
- 12 sites in United States
- Volunteers
- 69 people
- Sponsor
- Incyte Corporation
Knee Osteoarthritis, Bone; Deformity, Congenital
COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients
The Columbus® Revision endoprosthetic system is bearing the CE-mark. This means that within the scope of this observational study the patient will not be subjected to any additional stressful, study-related medical examinations…
- Conditions
- Knee Osteoarthritis, Bone; Deformity, Congenital, Prosthesis Failure, Prosthesis-Related Infections
- Trial name
- COREV (NCT05113303)
- Testing
- Navigated Revision Total Knee Arthroplasty, Manual Revision Total Knee Arthroplasty
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Aesculap AG
Bone Marrow Transplant Infection
The DISCOVER Trial (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time)
Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard…
- Trial name
- DISCOVER (NCT02804464)
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Karius, Inc.
Bone Diseases, Infectious
Drug Penetration Into Bone After Repeated Oral Administration of Debio 1450 to Patients Undergoing Hip Replacement Surgery
Debio 1450 is being developed for the treatment of staph (staphylococcal) infections. How fast and completely an antibiotic penetrates into bone is used to determine how effective it might be to treat infections related to bones…
- Trial name
- NCT02726438
- Testing
- Debio 1450
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Debiopharm International SA
Adenocarcinoma, Adenocystic Carcinoma
The Registry of Oncology Outcomes Associated With Testing and Treatment
This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation.
- Conditions
- Adenocarcinoma, Adenocystic Carcinoma, Anal Cancer, Appendix Cancer
- Trial name
- ROOT (NCT04028479)
- Testing
- Biomarker Testing (L), Systemic Treatment (T), Patient Reported Outcomes (P)
- Where
- 2 sites in United States
- Volunteers
- 167 people
- Sponsor
- Taproot Health
Axial Spondyloarthritis
Continuing Versus Withdrawing Adalimumab in Maintaining Remission in Non-Radiographic Axial Spondyloarthritis
The objective of this multicenter, randomized, double-blind study was to evaluate the efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given every other week SC in maintaining remission in…
- Trial name
- NCT01808118
- Testing
- adalimumab
- Volunteers
- 673 people
- Sponsor
- AbbVie
Hepatitis B
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents.
- Trial name
- NCT02479880
- Testing
- Tenofovir DF, DEXA Scan
- Where
- 11 sites in Belgium, France and 5 more
- Volunteers
- 30 people
- Sponsor
- Gilead Sciences
Degenerative Disc Disease, Spinal Stenosis
Burst Biologics Spinal Fusion Registry
A multicenter patient registry was created with aim of documenting how spine and neurosurgeons are utilizing Burst Biologics products along with patient outcomes.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylitis, Spondylolisthesis
- Trial name
- NCT03064802
- Testing
- BioBurst Fluid, Burst Allograft
- Where
- 4 sites in United States
- Volunteers
- 450 people
- Sponsor
- Burst Biologics
Ankylosing Spondylitis
Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis
This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It is designed to obtain information on the efficacy and safety of 3 different doses of tofacitinib.
- Trial name
- NCT01786668
- Testing
- Tofacitinib 2 mg, Tofacitinib 5 mg, Tofacitinib 10 mg
- Where
- 67 sites in United States, Canada and 8 more
- Volunteers
- 208 people
- Sponsor
- Pfizer
Pressure Ulcer, Stage IV, Osteomyelitis
A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.
The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only)…
- Trial name
- BLADE OPU2 (NCT06283979)
- Testing
- STIMULAN VG, Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Biocomposites Ltd
Tibial Fractures, Fracture Infection
Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study
Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation.
- Trial name
- NCT05022485
- Testing
- ZNN Bactiguard tibia
- Where
- 16 sites in Austria, France and 6 more
- Volunteers
- 500 people
- Sponsor
- Zimmer Biomet
Leukemia, Myeloid, Chronic, Myeloid Leukemia
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase…
- Conditions
- Leukemia, Myeloid, Chronic, Myeloid Leukemia, Chronic Myeloid Leukemia, Philadelphia Positive Acute Lymphoblastic Leukemia
- Trial name
- NCT04260022
- Testing
- Ascentage Pharma HQP1351 bioavailable inhibitor, Blinatumomab
- Where
- 9 sites in United States, Canada
- Volunteers
- 242 people
- Sponsor
- Ascentage Pharma Group Inc.
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Adenovirus Infection
Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).
- Trial name
- NCT05179057
- Testing
- Posoleucel
- Where
- 47 sites in United States, Canada and 4 more
- Volunteers
- 57 people
- Sponsor
- AlloVir
Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Revision Hip Prosthesis System in adult participants…
- Conditions
- Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint, Prostheses-related Infections, Joint Instability
- Trial name
- NCT07653295
- Testing
- Tıpmed™ Revision Hip Prosthesis System
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 35 people
- Sponsor
- TIPMED Medical Device Manufacturing Ltd. Co.
Osteomyelitis
Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis
This clinical study will be a multi-center, randomized, open-label, active-controlled, parallel-group study comparing dalbavancin to standard of care (SOC) therapy in osteomyelitis.
- Trial name
- NCT03091439
- Testing
- Dalbavancin, Standard of Care
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Allergan