Clinical trials: Surveillance
Fabry Disease
China Post-marketing Surveillance (PMS) Study of Fabrazyme®
This is a 54-week Phase 4, open label, single arm study to evaluate the safety and the efficacy of Fabrazyme (agalsidase beta) as enzyme replacement therapy (ERT) in Chinese participants with Fabry Disease.
- Trial name
- NCT05054387
- Testing
- Agalsidase beta
- Where
- 6 sites in China
- Volunteers
- 22 people
- Sponsor
- Genzyme, a Sanofi Company
Wound
PMS Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds
Post Market Surveillance Study to confirm the safety and performance of Silver II Non-Woven Dressing in Chronic and Acute Wounds
- Trial name
- NCT05045430
- Testing
- Silver II Non-Woven Dressing
- Where
- 8 sites in South Africa, United Kingdom
- Volunteers
- 240 people
- Sponsor
- Advanced Medical Solutions Ltd.
Chronic Leukemia Myelogenous
A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML).
The purpose of this study is to look at how safe and effective is bosulif in routine clinical practice. This study is seeking for participants who are: 1.
- Trial name
- NCT06297161
- Testing
- Bosulif
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Pfizer
Hemophilia A
Post Marketing Surveillance Study for ADYNOVATE in South Korea
The main aim of this study is to check for side effects and medical problems in participants with hemophilia A who are receiving ADYNOVATE in routine clinical practice.
- Trial name
- NCT03824522
- Testing
- ADYNOVATE
- Where
- 8 sites in South Korea
- Volunteers
- 341 people
- Sponsor
- Takeda
Hepatitis C Virus
Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India
This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens administered as per the approved prescribing information in adults with chronic hepatitis C virus (HCV) infection treated in routine clinical…
- Trial name
- NCT02592057
- Testing
- SOF
- Where
- 26 sites in India
- Volunteers
- 532 people
- Sponsor
- Gilead Sciences
Hepatitis B
HEPSERA Post Marketing Surveillance
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of adefovir dipivoxil administered in Korean CHB patients according to the prescribing information
- Trial name
- HEPSERA PMS (NCT01329419)
- Testing
- adefovir dipivoxil
- Volunteers
- 4,393 people
- Sponsor
- GlaxoSmithKline
Arthritis, Psoriatic
Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis
The aim of this study is to evaluate if the data obtained in controlled clinical trials are confirmed when Enbrel is used in usual clinical practice in Belgium according to local reimbursement criteria.
- Trial name
- PROVE (NCT00938015)
- Testing
- Questionnaire
- Where
- Belgium
- Volunteers
- 303 people
- Sponsor
- Pfizer
Diabetes Mellitus, Type 2
PMS of Trazenta on the Long-term Use as Add-on Therapy
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.
- Trial name
- NCT01904383
- Testing
- Trazenta
- Where
- Japan
- Volunteers
- 4,057 people
- Sponsor
- Boehringer Ingelheim
Carcinoma, Hepatocellular
INSIGHT - Post Marketing Surveillance
In this international non-interventional post-marketing surveillance study we want to evaluate patient characteristics in HCC patients as well as efficacy and safety of Sorafenib (Nexavar®) treatment under daily-life treatment…
- Trial name
- INSIGHT (NCT00792350)
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- 2 sites in Austria, Germany
- Volunteers
- 791 people
- Sponsor
- Bayer
Relapsed/Refractory Multiple Myeloma
NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma"
The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.
- Trial name
- NCT03169361
- Testing
- Ixazomib
- Where
- Japan
- Volunteers
- 774 people
- Sponsor
- Takeda
Fistula-in-ano
BioHealx® Anal Fistula Device Post Market Surveillance Study
This post market surveillance study is a single arm multicenter study to demonstrate the long-term durability and effectiveness of the BioHealx Anal Fistula Device for fistula-in-ano closure (internal and external fistula…
- Trial name
- NCT07021742
- Testing
- BioHealx
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- Signum Surgical USA Inc.
Cardiovascular Surgical Procedure
CardioRoot Post-Marketing Surveillance Registry
Post-marketing surveillance registry of the CardioRoot graft.
- Trial name
- CardioRoot (NCT01609270)
- Testing
- CardioRoot graft
- Where
- 6 sites in Czechia, France and 1 more
- Volunteers
- 52 people
- Sponsor
- Maquet Cardiovascular
Coronary Artery Disease
TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program
The TAXUS ARRIVE study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical…
- Trial name
- ARRIVE (NCT00569491)
- Testing
- TAXUS Express 2™
- Where
- 50 sites in United States
- Volunteers
- 2,585 people
- Sponsor
- Boston Scientific Corporation
Obstructive Sleep Apnea (OSA)
A Post-marketing Surveillance of the Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea
This is a post-marketing surveillance study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
- Trial name
- NCT02698059
- Testing
- iNAP® Sleep Therapy System (iNAP)
- Where
- 8 sites in Germany, Taiwan
- Volunteers
- 63 people
- Sponsor
- Somnics, Inc.
Aortic Valve Stenosis
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV).
- Trial name
- TAB-R (NCT02099942)
- Testing
- V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- InterValve, Inc.
Parkinson Disease
Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease
The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval.
- Trial name
- NCT02248168
- Testing
- Pramipexole
- Volunteers
- 1,449 people
- Sponsor
- Boehringer Ingelheim
Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other
Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"
The purpose of this study is to evaluate the safety and efficacy on participants receiving first-line eradication and second-line eradication including vonoprazan (Takecab) tablets (triple therapy) in the routine clinical setting.
- Trial name
- NCT03219723
- Testing
- Vonoprazan, Amoxicillin hydrate, Clarithromycin
- Where
- Japan
- Volunteers
- 560 people
- Sponsor
- Takeda
Epilepsy, Neuropathic Pain
Lyrica (Pregabalin) Korean Post Marketing Surveillance Study
This study collects post-marketing safety and efficacy surveillance data in real world clinical use of pregabalin for its approved indications in Korea.
- Conditions
- Epilepsy, Neuropathic Pain, Fibromyalgia, Post-market Surveillance
- Trial name
- NCT01220180
- Testing
- pregabalin (Lyrica)
- Volunteers
- 4,175 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Rheumatoid Arthritis, Osteoarthritis
A Single Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
The purpose of this study is to monitor the performance and determine the metal ion release of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders
- Trial name
- NCT00872794
- Testing
- DePuy ASR™ Hip System
- Where
- South Africa
- Volunteers
- 50 people
- Sponsor
- DePuy International
Bipolar Disorder, Schizophrenia
Post-Authorization Safety Surveillance Study of Asenapine in Participants With Bipolar Disorder (P08307)
This study will assess asenapine (Sycrest®) use in participants with bipolar disorder; comparison will be made to the use of risperidone (RISPERDAL®CONSTA®) and olanzapine (Zyprexa®).
- Trial name
- NCT01495741
- Volunteers
- 42 people
- Sponsor
- Organon and Co
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