Clinical trials: High Risk
Paroxysmal Nocturnal Hemoglobinuria
Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab
The primary purpose of this study is to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab in participants who are prescribed and are receiving a higher than approved dose of eculizumab to treat…
- Trial name
- NCT04320602
- Testing
- Eculizumab, Ravulizumab
- Where
- 4 sites in United Kingdom
- Volunteers
- 18 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Relapsed or Refractory (R/R) Follicular Lymphoma (FL), Diffuse Large B-Cell Lymphoma (DLBCL)
A Compassionate Use (CU) Program of Odronextamab
Provide compassionate use of odronextamab
- Conditions
- Relapsed or Refractory (R/R) Follicular Lymphoma (FL), Diffuse Large B-Cell Lymphoma (DLBCL), B-Cell Non-Hodgkin Lymphoma (NHL), High-Grade B-Cell Lymphoma (HGBCL)
- Trial name
- NCT05619367
- Testing
- Odronextamab
- Sponsor
- Regeneron Pharmaceuticals
Covid19
Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.
The COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19.
- Trial name
- NCT04913675
- Testing
- sotrovimab
- Where
- 50 sites in United States, France and 1 more
- Volunteers
- 1,065 people
- Sponsor
- Vir Biotechnology, Inc.
Respiratory Syncytial Virus (RSV)
A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus
This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for…
- Trial name
- Synagis Russia (NCT02968173)
- Testing
- Palivizumab
- Volunteers
- 50 people
- Sponsor
- AbbVie
Influenza
Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age
The objectives of this study were: To describe the safety of each dosage of high-dose quadrivalent influenza vaccine (QIV-HD) used in the study during the 28 days following each vaccination, and serious adverse events (including…
- Trial name
- QHD04 (NCT03698279)
- Testing
- High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated), High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated), High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated)
- Where
- 16 sites in United States, Canada
- Volunteers
- 665 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
MCNS, Minimal Change Nephrotic Syndrome (MCNS)
A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome
To compare the therapeutic effect of tacrolimus in combination with low-dose corticosteroid with high-dose corticosteroid alone in patients with minimal-change nephrotic syndrome.
- Trial name
- T-OPTIMUM (NCT01763580)
- Testing
- Tacrolimus, Prednisolone
- Where
- South Korea
- Volunteers
- 144 people
- Sponsor
- Astellas Pharma Korea, Inc.
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
This LTFU is being conducted to assess long-term safety and durability of response in participants dosed with IP in a parent protocol, and to collect longitudinal natural history in enrolled but not dosed participants who also…
- Conditions
- Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease, Urea Cycle Disorders, Inborn
- Trial name
- NCT06805695
- Testing
- No Intervention
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 13 people
- Sponsor
- iECURE, Inc.
COVID-19 SARS-CoV-2 Infection
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease.
- Trial name
- NCT06679140
- Testing
- ibuzatrelvir
- Where
- 256 sites in United States, Argentina and 17 more
- Volunteers
- 2,330 people
- Sponsor
- Pfizer
Influenza, Flu
Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines
The aim of the study was to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone Quadrivalent vaccine in children 6 months to < 9 years of age, and in adults 18 to < 65 years of age, and to describe the…
- Trial name
- NCT03308825
- Testing
- Fluzone Quadrivalent vaccine, Fluzone High-Dose vaccine
- Where
- 3 sites in United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Carotid Artery Disease
CHOICE: Carotid Stenting For High Surgical-Risk Patients
The purposes of this study is to 1) Provide additional information that the commercially available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used successfully by a wide range of physicians under…
- Trial name
- NCT00406055
- Testing
- RX ACCULINK , RX ACCUNET , XACT , EMBOSHIELD and EMBOSHIELD Nav6
- Where
- United States
- Volunteers
- 18,855 people
- Sponsor
- Abbott Medical Devices
COVID-19, SARS-COV-2 Infection
A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19.
- Trial name
- NCT07069309
- Testing
- BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
- Where
- 19 sites in United States
- Volunteers
- 774 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
COVID-19
Trial to Evaluate Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness
The purpose of this study is to determine whether nitazoxanide (NTZ) is safe and effective in treating mild or moderate COVID-19 illness in adults and adolescents at highest risk for severe outcomes.
- Trial name
- NCT05157243
- Testing
- Nitazoxanide, Vitamin Super-B Complex, Standard of Care
- Sponsor
- Romark Laboratories L.C.
Migraine
Nerivio Efficacy Under High-Frequency Use
This is a Post-marketing study investigating the impact of frequant usage with Nerivio on the safety profile of Remote Electrical Neuromodulation (REN) for the treatment of migraine.
- Trial name
- NCT07336056
- Testing
- Nerivio (REN device)
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Theranica
Catecholamine-resistant Hypotension (CRH), Distributive Shock
A Study of LJPC-501 in Pediatric Patients With Hypotension
The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) or reduction in sum norepinephrine (NE) equivalent dosing, at Hour 2 after the start of LJPC-501, in pediatric patients…
- Conditions
- Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock, Sepsis
- Trial name
- NCT03431077
- Testing
- Angiotensin II
- Where
- 3 sites in United States
- Volunteers
- 2 people
- Sponsor
- La Jolla Pharmaceutical Company
Bronchopulmonary Dysplasia
A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD)
The purpose of this study is to determine if an investigational drug, AT-100, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in babies born premature, as compared to babies born premature who receive an air-sham…
- Trial name
- NCT04662151
- Testing
- AT-100
- Where
- 19 sites in United States, Spain
- Volunteers
- 37 people
- Sponsor
- Airway Therapeutics, Inc.
Neuroblastoma, Relapsed Neuroblastoma
67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk, Relapsed, Refractory Neuroblastoma
The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma.
- Conditions
- Neuroblastoma, Relapsed Neuroblastoma, Refractory Neuroblastoma
- Trial name
- NCT04023331
- Testing
- 67Cu-SARTATE, 64Cu-SARTATE
- Where
- 8 sites in United States
- Volunteers
- 21 people
- Sponsor
- Clarity Pharmaceuticals Ltd
Chronic Kidney Diseases, Renal Disease
Evaluation of Renastep
Evaluation of Renastep is a 28-day long, prospective nutritional study that will recruit 15 patients aged between 3 and 18 years of age with Chronic Kidney Disease.
- Trial name
- Renastep (NCT03602937)
- Testing
- Renastep
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Vitaflo International, Ltd
Candidiasis, Systemic, Candida Meningitis
Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis
The primary purpose of this study is to evaluate the pharmacokinetic profile of micafungin administered to neonates suffering from systemic candidiasis.
- Trial name
- NCT03421002
- Testing
- Micafungin
- Where
- 2 sites in Italy
- Volunteers
- 35 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Buprenorphine, Naloxone
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic…
- Conditions
- Buprenorphine, Naloxone, Opiate-related Disorders, Opiate Dependence
- Trial name
- OPUS R (NCT00723697)
- Testing
- buprenorphine
- Volunteers
- 1,307 people
- Sponsor
- Indivior Inc.
Aortic Valve Stenosis
RESPOND Post Market Study
The purpose of the RESPOND post market study is to collect real world clinical and device performance outcomes data with the Lotus Valve System used in routine clinical practice to demonstrate that the commercially available…
- Trial name
- RESPOND (NCT02031302)
- Testing
- Lotus Valve System
- Where
- 41 sites in Colombia, Finland and 11 more
- Volunteers
- 1,064 people
- Sponsor
- Boston Scientific Corporation