Clinical trials: Safety Plan
Pneumococcal Infections
Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)
The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs)…
- Trial name
- PNEU-PLAN (NCT03885934)
- Testing
- V114, Prevnar 13®
- Where
- 26 sites in Finland, Malaysia and 3 more
- Volunteers
- 606 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
18 to 24 F Percutaneous Femoral Arteriotomy Closure
Safety and Performance Study of Large Hole Vascular Closure Device
The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm its performance to percutaneously close femoral…
- Trial name
- Frontier-III (NCT02788448)
- Testing
- VIVASURE CLOSURE DEVICE
- Where
- 3 sites in Germany
- Volunteers
- 42 people
- Sponsor
- Vivasure Medical Limited
Chronic Hepatitis B
Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
The purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.
- Trial name
- NCT01026610
- Testing
- LB80380 90 mg, LB80380 150 mg, entecavir 0.5 mg
- Where
- 10 sites in China, South Korea
- Volunteers
- 115 people
- Sponsor
- LG Life Sciences
Neuropathic Pain
Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)
The objective of this investigation is to evaluate the safety and efficacy of long term use with Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will…
- Trial name
- RAINBOW-L (NCT01279850)
- Testing
- Pregabalin (Lyrica) capsule
- Volunteers
- 891 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Suicide, Mental Health Disorder
A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents
Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be…
- Conditions
- Suicide, Mental Health Disorder, Anhedonia
- Trial name
- ViraSafeRCT (NCT07348666)
- Testing
- ViraSafe: Treatment pushes, BRITE
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Ksana Health
Neurosurgery
Post-market Clinical Follow-up Plan of StypCel™ Absorbable Hemostat
This study is a post-market clinical follow-up (PMCF) plan for the StypCel™ Absorbable Hemostat, a medical device used to control bleeding during neurosurgery. The study include 108 patients .
- Trial name
- PMCFStypcel (NCT07199439)
- Where
- Latvia
- Volunteers
- 108 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Glaucoma, Ocular Hypertension
Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension
The objective of this Investigation is to evaluate the safety and efficacy of long-term treatment with Xalacom in medical practice.
- Trial name
- NCT01191008
- Testing
- Latanoprost-timolol maleate fixed combination ophthalmic solution
- Volunteers
- 661 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hepatocellular Carcinoma (HCC)
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere.
- Trial name
- ADVANCE-MCD (NCT07669727)
- Testing
- TheraSphere
- Volunteers
- 140 people
- Sponsor
- Boston Scientific Corporation
HIV-1 Infection
Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this…
- Trial name
- NCT00823966
- Testing
- Rescriptor
- Volunteers
- 3 people
- Sponsor
- Pfizer
Percutaneous Arteriotomy Closure
Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER V Study
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 90 patients in up to 8 European investigational sites.
- Trial name
- NCT04799769
- Testing
- Percutaneous arterial closure device
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 90 people
- Sponsor
- Vivasure Medical Limited
Postoperative Pain
PK and Safety After C-Section
The main goal of the study was to measure the amount of the active ingredients and other components of HTX-011 in plasma and expressed breast milk over time following postpartum administration in women undergoing a planned…
- Trial name
- NCT03955211
- Testing
- HTX-011, ZYNRELEF kit components for administration, MMA regimen
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Heron Therapeutics
Atopic Dermatitis (AD), Asthma
Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy
The objective is to evaluate the potential effect of exposure to dupilumab in pregnancy compared to the primary comparison group of disease-matched pregnant women who are not exposed to dupilumab, and the secondary comparison…
- Trial name
- NCT04173442
- Testing
- dupilumab
- Where
- United States
- Volunteers
- 581 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Solid Tumor, Colorectal Cancer
Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer
Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial
- Conditions
- Solid Tumor, Colorectal Cancer, Sigmoid Colon Cancer, Rectosigmoid Junction Cancer
- Trial name
- NCT05943041
- Testing
- GB104(Level 1), GB104(Level 2), GB104(Level 3)
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- GILongevity
Pneumococcal Vaccine, Streptococcus Pneumoniae
Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)
This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months…
- Trial name
- NCT01521897
- Testing
- 7-valent vaccine injection
- Where
- Japan
- Volunteers
- 1,143 people
- Sponsor
- Pfizer
Tuberculosis, Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT00810407
- Testing
- rifabutin
- Volunteers
- 628 people
- Sponsor
- Pfizer
Coronary Disease
Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome
Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive…
- Trial name
- SEPIA-ACS1 (NCT00317395)
- Testing
- Otamixaban (XRP0673), unfractionated heparin, eptifibatide
- Where
- 36 sites in United States, Argentina and 34 more
- Volunteers
- 3,241 people
- Sponsor
- Sanofi
Epilepsy, Partial
Meta-Analysis Plan for Pooled Data for Studies VRX-RET-E22-303 and VRX-RET-E22-304
The objective of this meta-analysis is to provide data on long-term safety and efficacy following the recent positive Committee for Medicinal Products for Human Use (CHMP) opinion for retigabine using pooled data from ongoing…
- Trial name
- NCT01457989
- Testing
- retigabine/ezogabine
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Vaginal Dysbiosis
Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle
The goal of this clinical trial is to evaluate FB301 during a mock frozen embryo transfer (FET) cycle in pre-menopausal women aged 18 to 45 years with a prior failed FET and a defined vaginal bacterial imbalance (dysbiosis).
- Trial name
- NCT07453069
- Testing
- FB-301, Chlorhexidine (0.5%) Vaginal Cleanse
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Freya Biosciences ApS
Neuralgia
Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan)
The objective of this Investigation is to evaluate the safety and efficacy of Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will be monitored…
- Trial name
- RAINBOW (NCT01256593)
- Testing
- Pregabalin (Lyrica) capsule
- Volunteers
- 3,827 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Ileus, Gastro-Intestinal Disorder
A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.
- Trial name
- INTEGRITY (NCT05470387)
- Testing
- LB1148
- Where
- 23 sites in United States
- Volunteers
- 23 people
- Sponsor
- Palisade Bio