Clinical trials: Safety
Sjogren's Syndrome
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome
Background: An autoimmune disease is one in which the immune system attacks a person's own body. Sjogren's syndrome (SS) is an autoimmune disease. It often involves multiple systems and organs of the body.
- Trial name
- NCT04496960
- Testing
- tofacitinib
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
Atrial Fibrillation
A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF
The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial…
- Trial name
- DISRUPT-AF (NCT06335082)
- Testing
- Pulsed Field Ablation
- Where
- 36 sites in United States
- Volunteers
- 10,000 people
- Sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
Antineutrophil Cytoplasmic Antibody-associated Vasculitis
A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
- Trial name
- AVASET (NCT06072482)
- Testing
- Avacopan, Standard of Care
- Where
- 83 sites in United States, Czechia and 5 more
- Volunteers
- 300 people
- Sponsor
- Amgen
Acute Myeloid Leukemia
A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia
To compare disease-free survival in patients 60 years or older with acute myeloid leukemia (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.
- Trial name
- NCT01961882
- Testing
- OCV-501
- Where
- 14 sites in Japan, South Korea and 1 more
- Volunteers
- 134 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Advanced Esophageal Squamous Cell Carcinoma
To Evaluate the Efficacy and Safety of Afatinib for Advanced ALTRK-negative ESCC
This is a phase II study to evaluate the effectiveness and safety of Afininib compared to irinotecan in the 3-gene RNA sequencing (ALTRK) negative advanced esophageal squamous squamous carcinoma.
- Trial name
- NCT05818982
- Testing
- Afatinib, Irinotecan
- Where
- 3 sites in China
- Volunteers
- 72 people
- Sponsor
- Peking University
Skin Aging of Dorsal Hands
Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lido and Vital Without Lido in Dorsal Hand
This is a randomized, multi-center, split-hand, subject-blinded study comparing pain, safety and effectiveness of Restylane Skinboosters Vital Lidocaine and Restylane Vital without lidocaine for improving appearance of the dorsal…
- Trial name
- NCT06372782
- Testing
- Restylane Skinboosters Vital Lidocaine, Restylane Vital
- Where
- 3 sites in China
- Volunteers
- 90 people
- Sponsor
- Galderma R&D
Acute Myeloid Leukemia (AML)
Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML
This trial will evaluate whether luveltamab tazevibulin is well tolerated and active against a rare form of AML carrying a particular genetic abnormality called CBFA2T3::GLIS2 that arises in infants and children.
- Trial name
- NCT06679582
- Testing
- Luveltamab tazevibulin
- Where
- 36 sites in United States, Austria and 7 more
- Volunteers
- 1 people
- Sponsor
- Sutro Biopharma, Inc.
Traumatic Brain Injury, Intracranial Hemorrhages
Andexanet Alfa for Reversal of Factor Xa Inhibitors in Traumatic Brain Injury: A Retrospective Single-Centre Study
Elderly patients on direct oral anticoagulants (DOACs), specifically factor Xa (FXa) inhibitors such as apixaban and rivaroxaban are at elevated risk of haematoma expansion following traumatic brain injury (TBI).
- Trial name
- AA-TBI (NCT07898982)
- Where
- Slovenia
- Volunteers
- 34 people
- Sponsor
- University Medical Centre Ljubljana
Gout
D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers
This initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD of D-0120-NA in fasting…
- Trial name
- NCT03291782
- Testing
- D-0120
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Crohn's Disease
A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
The primary objective of this study is to evaluate long-term effectiveness of adalimumab in pediatric participants starting a treatment for Crohn's disease in real life conditions, namely to describe the time to loss of clinical…
- Trial name
- LEA (NCT03017014)
- Where
- 24 sites in France
- Volunteers
- 62 people
- Sponsor
- AbbVie
Schizophrenia
Study Evaluating Vabicaserin in Subjects With Schizophrenia
The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.
- Trial name
- NCT00563706
- Testing
- vabicaserin, risperidone
- Where
- 33 sites in United States, Canada
- Volunteers
- 199 people
- Sponsor
- Pfizer
Tetanus, Tetanus Vaccine
Phase I/III Clinical Trial of Adsorbed Tetanus Vaccine
The study aimed to evaluate the safety and immunogenicity of an adsorbed tetanus vaccine in healthy individuals between 18 and 43 years of age.
- Trial name
- NCT07740733
- Testing
- Tetanus Toxoid (Adsorbed)
- Where
- China
- Volunteers
- 1,240 people, healthy volunteers welcome
- Sponsor
- Beijing Minhai Biotechnology Co., Ltd
Non-Small Cell Lung Cancer
A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)
This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable…
- Trial name
- B-FAST (NCT03178552)
- Testing
- Alectinib, Atezolizumab, Pemetrexed
- Where
- 161 sites in United States, Argentina and 25 more
- Volunteers
- 1,000 people
- Sponsor
- Hoffmann-La Roche
Essential Hypertension
Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine
This study will assess the efficacy and safety of the single pill combination of Aliskiren and Amlodipine in patients with moderate hypertension not adequately responding to a single pill combination of Olmesartan and Amlodipine.
- Trial name
- AWESOME (NCT01113047)
- Testing
- Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ
- Where
- Germany
- Volunteers
- 347 people
- Sponsor
- Novartis
Advanced Solid Tumor
Study SC-101 in Subjects With Advanced Malignancies
This study will evaluate the safety, pharmacokinetics, and anti-cancer efficacy of SC-101 in subjects with advanced or metastatic solid tumors.
- Trial name
- NCT06220838
- Testing
- SC-101
- Where
- 5 sites in China
- Volunteers
- 100 people
- Sponsor
- Tianjin ConjuStar Biologics Co., Ltd.
Primary Hypertension, Secondary Hypertension
Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension
This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and safety of lisinopril in children 1-18y whose parents grant permission to participate.
- Trial name
- Lisi-ped (NCT02184858)
- Testing
- lisinopril, ACE-inhibitor
- Where
- Belgium
- Volunteers
- 13 people
- Sponsor
- University Ghent
Mycoses
Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)
This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections: A: which are refractory or resistant to…
- Trial name
- NCT00034658
- Testing
- Posaconazole
- Volunteers
- 336 people
- Sponsor
- Merck Sharp & Dohme LLC
Gastric Cancer Stage IV, Peritoneal Carcinomatosis
Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6
Treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for decades. The median survival for stage 4 gastric cancer is 9-14 months with systemic chemotherapy.
- Conditions
- Gastric Cancer Stage IV, Peritoneal Carcinomatosis, Intraperitoneal Paclitaxel, mFOLFOX6
- Trial name
- IPLUS (NCT03618758)
- Testing
- Paclitaxel, mFOLFOX6 regimen
- Where
- South Korea
- Volunteers
- 35 people
- Sponsor
- Seoul National University Bundang Hospital
Healthy Volunteers
Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers
This single-center study will be conducted in 3 phases: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-dose phase (up to 5 cohorts, 9 subjects/cohort), and a midazolam drug-drug interaction phase…
- Trial name
- NCT03276858
- Testing
- CRN00808, Midazolam oral solution
- Where
- Australia
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Crinetics Pharmaceuticals Inc.
Hypogonadism
Open-Label Study of ARD-0403 in Testosterone Deficient Men
Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient wellbeing.
- Trial name
- NCT00448955
- Testing
- ARD-0403
- Where
- 12 sites in United States
- Volunteers
- 150 people
- Sponsor
- Ardana Bioscience Ltd