Clinical trials: Pathologic Processes
Alpha 1 Antitrypsin Deficiency
A Study of AIR-001 in Adults With Alpha-1 Antitrypsin Deficiency (AATD)
This is a Phase 1, open-label, single ascending dose (SAD) and multiple dose (MD) study of AIR-001 in participants with alpha-1 antitrypsin deficiency (AATD) due to PiZZ genotype.
- Trial name
- RepAIR1 (NCT07431112)
- Testing
- AIR-001 SAD dose level 1, AIR-001 SAD dose level 2, AIR-001 SAD dose level 3
- Where
- 13 sites in Australia, Georgia and 7 more
- Volunteers
- 54 people
- Sponsor
- AIRNA Corporation
Carcinoma, Non-Small-Cell Lung
Pharmacokinetic Study of QL2107 Versus Keytruda® for Adjuvant Therapy of Non-Small Cell Lung Cancer (NSCLC)
The primary purpose of this study is to demonstrate Pharmacokinetic similarity in exposure after the initial dose and at steady state of QL2107 compared with Keytruda.
- Trial name
- NCT07162883
- Testing
- QL2107, Keytruda®
- Where
- 84 sites in Bosnia and Herzegovina, China and 11 more
- Volunteers
- 146 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Alpha 1 Antitrypsin Deficiency
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
This study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein.
- Trial name
- SWIFT-SC (NCT07555483)
- Testing
- Alpha-1 15%, Liquid Alpha1-PI
- Where
- 22 sites in United States, Denmark and 7 more
- Volunteers
- 40 people
- Sponsor
- Grifols Therapeutics LLC
Pathological Processes
This Study is the Clinical Validation Study for Validation for the Digital Pathology System 'SGi 1.0 + EPW 1.0 + Compatible Clinical Displays'
The primary objective of this study is to show safety and effectiveness of the investigational device for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical…
- Trial name
- NCT07881874
- Testing
- Digital pathology system
- Where
- 2 sites in United States
- Volunteers
- 470 people
- Sponsor
- Philips Digital & Computational Pathology
Hypertension, Vascular Diseases
SPYRAL GEMINI Pilot Study
The purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation with the Gemini System is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with…
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases
- Trial name
- SPYRAL GEMINI (NCT06907147)
- Testing
- Multi-Organ Denervation Gemini System
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 175 people
- Sponsor
- Medtronic Vascular
Inflammation, Pathologic Processes
Blood Markers of Inflammation, Blood Clotting and Blood Vessel Function in HIV-infected Adults
This study will collect information about markers of inflammation, blood clotting and blood vessel function in HIV-infected adults and healthy volunteers.
- Trial name
- NCT00776412
- Where
- United States
- Volunteers
- 310 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Critical Illness, Wounds and Injury
Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention
This study is a multicenter randomized controlled trial to determine the effectiveness of a closed loop/autonomous oxygen titration system (O2matic PRO100) to maintain normoxemia (goal range SpO2 90-96%, target 93%) during the…
- Conditions
- Critical Illness, Wounds and Injury, Disease Attributes, Pathologic Processes
- Trial name
- SAVE-O2 AI (NCT06374225)
- Testing
- Automated Titration (O2matic)
- Where
- 4 sites in United States
- Volunteers
- 300 people
- Sponsor
- University of Colorado, Denver
Hepatitis B, Chronic
Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region
This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with Nucleos(t)ide Analogue (NAs).
- Trial name
- ASPIRE-201 (NCT07370207)
- Testing
- AHB-137
- Where
- 10 sites in Australia, China and 5 more
- Volunteers
- 84 people
- Sponsor
- AusperBio Therapeutics Inc.
Ventricular Tachycardia
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled…
- Trial name
- NCT07585968
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 6 sites in United States
- Volunteers
- 260 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Alpha1-Antitrypsin Deficiency
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin Deficiency
The purpose of this study is to evaluate the safety and tolerability of 72 milligrams per kilogram (mg/kg) and 180 mg/kg Alpha-1 15%, administered as a single-dose subcutaneous (SC) infusion and subsequently as weekly SC…
- Trial name
- NCT04722887
- Testing
- Alpha-1 15%, Liquid Alpha1-Proteinase Inhibitor (Human)
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Grifols Therapeutics LLC
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC.
- Trial name
- SUNRAY-01 (NCT06119581)
- Testing
- LY3537982, Pembrolizumab, Cisplatin
- Where
- 416 sites in United States, Australia and 27 more
- Volunteers
- 1,264 people
- Sponsor
- Eli Lilly and Company
Acute Neurological Injury, Acute Medical Conditions
Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU
This study will demonstrate the impact of taVNS on reducing adverse events in NeuroICU patients, determine if taVNS reduces length of stay, and quantify the economic benefits of taVNS implementation in a broader neurocritical…
- Trial name
- TAVERN (NCT07219108)
- Testing
- Auricular Vagus Nerve Stimulation
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Washington University School of Medicine
Type and Grade of Toxicities, Demographic and Background Characteristics, Advanced, Metastatic, Recurrent Adenocarcinoma and Malignant Solid Neoplasm
Labyrinthin Vaccination in Veterans With Lung Adenocarcinoma
This phase 2 trial tests the safety and effectiveness of a cancer vaccine called LabVax 3(22)-23 and GM-CSF in combination with pembrolizumab in treating adenocarcinoma that has spread to other places in the body (advanced…
- Trial name
- NCT07859592
- Testing
- LabVax 3(22)-23 and GM-CSF (adjuvant) in combination with pembrolizumab
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- VA Office of Research and Development
Sepsis, Septic Shock
Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic…
- Trial name
- SYMON II (NCT06654895)
- Where
- 5 sites in United States
- Volunteers
- 700 people
- Sponsor
- Bluejay Diagnostics, Inc.
Short Bowel Syndrome
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data.
- Trial name
- EASE SBS 5 (NCT07197944)
- Testing
- Glepaglutide
- Where
- 33 sites in United States, Austria and 12 more
- Volunteers
- 90 people
- Sponsor
- Zealand Pharma
Sepsis, Septic Shock
Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study
The primary objective of this study is to establish an IL-6 concentration cutoff that predicts sepsis or septic shock (according to the Third International Consensus Definitions (Sepsis-3 criteria)) in patients who are admitted…
- Trial name
- SYMON III (NCT07425587)
- Where
- 5 sites in United States
- Volunteers
- 450 people
- Sponsor
- Bluejay Diagnostics, Inc.
Inflammatory Bowel Disease, Colitis, Ulcerative
A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment…
- Conditions
- Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn's Disease
- Trial name
- GORGEOUS (NCT07102368)
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Janssen-Cilag G.m.b.H
Hepatitis B, Chronic
Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions
This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with CHB treated with Nucleos(t)ide Analogue (NAs).
- Trial name
- ASPIRE-202 (NCT07654283)
- Testing
- AHB-137
- Where
- 10 sites in United States, Canada and 4 more
- Volunteers
- 70 people
- Sponsor
- AusperBio Therapeutics Inc.
B-precursor Acute Lymphoblastic Leukemia, ALL
GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL
It is an open-label dose-escalating study in sequential cohorts to assess safety and pharmacokinetics of GNR-084.
- Conditions
- B-precursor Acute Lymphoblastic Leukemia, ALL, GNR-084
- Trial name
- NCT04601584
- Testing
- Cohort 1, GNR-084, Cohort 2, GNR-084, Cohort 3, GNR-084
- Where
- 3 sites in Russia
- Volunteers
- 14 people
- Sponsor
- AO GENERIUM
Osteonecrosis of the Femoral Head, Avascular Necrosis of the Femoral Head
Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis
Osteonecrosis of the femoral head (ONFH) is a debilitating musculoskeletal disease that is characterized by localized death of bone cells and associated cellular elements within the subchondral bone.
- Trial name
- BATON (NCT06123481)
- Testing
- Core Decompression, Core Decompression Procedure with Autologous Bone Marrow Aspirate Concentrate
- Where
- 10 sites in United States
- Volunteers
- 192 people
- Sponsor
- Johns Hopkins University