Clinical trials: PMS
Breast Cancer
Halaven Post-Marketing Surveillance (PMS)
This is a PMS to observe the safety profile of Halaven in normal clinical practice setting.
- Trial name
- NCT02441764
- Where
- 12 sites in South Korea
- Volunteers
- 3,000 people
- Sponsor
- Eisai Korea Inc.
Prevention of Infectious Disease Caused by SARS-CoV-2
VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Subjects With Underlying Disease at High-risk for Worsening COVID-19
To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance…
- Trial name
- NCT05084755
- Where
- 3 sites in Japan
- Volunteers
- 4 people
- Sponsor
- AstraZeneca
Macular Degeneration
Eylea Post Marketing Surveillance(PMS)
The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by MFDS
- Trial name
- NCT01783925
- Testing
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Where
- South Korea
- Volunteers
- 3,206 people
- Sponsor
- Bayer
Pulmonary Disease, Chronic Obstructive
Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease
Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting
- Trial name
- NCT02850978
- Testing
- Spiolto
- Where
- Japan
- Volunteers
- 1,335 people
- Sponsor
- Boehringer Ingelheim
Liver
Primovist Regulatory Post Marketing Surveillance (PMS)
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice
- Trial name
- NCT00924248
- Testing
- Gadoxetic acid disodium (Primovist, BAY86-4873)
- Where
- South Korea
- Volunteers
- 4,358 people
- Sponsor
- Bayer
Relapsing-Remitting Multiple Sclerosis
A Postmarketing Surveillance (PMS) Study to Evaluate the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis (MS) With Interferon Beta 1a (Rebif®)
This was an open-label, multicentric, prospective, post-marketing surveillance (PMS) study on the extent to which subject compliance is influenced by use of a variable titration regimen at the start of treatment of relapsing MS…
- Trial name
- TOURIMS (NCT01142492)
- Testing
- Interferon beta-1a
- Volunteers
- 403 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
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
Lung Cancer, Small Cell
Regulatory Hycamtin(Oral) PMS
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Topotecan administered in Korean patients according to the prescribing information
- Trial name
- Hycamtin PMS (NCT01037023)
- Testing
- Topotecan
- Where
- 2 sites in South Korea
- Volunteers
- 92 people
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Post Marketing Surveillance for ADACEL™ in South Korea
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug".
- Conditions
- Diphtheria, Tetanus, Pertussis
- Trial name
- NCT01137435
- Testing
- ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
- Where
- 2 sites in South Korea
- Volunteers
- 659 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Osteoporosis
BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )
This is an open label, multi-centre, non-interventional post-marketing surveillance.
- Trial name
- BONPMS (NCT01381393)
- Testing
- Ibandronate
- Where
- South Korea
- Volunteers
- 659 people
- Sponsor
- GlaxoSmithKline
Poliomyelitis
A Post-marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children
Following licensing of PoliorixTM in Korea, this study will collect safety data about the routine use of this vaccine in 600 children according to the regulations of Korean Food and Drugs Administration (KFDA).
- Trial name
- NCT00514033
- Testing
- Poliomyelitis vaccine (inactivated) -PoliorixTM
- Where
- South Korea
- Volunteers
- 349 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hemophilia B
RIXUBIS PMS India (RIXUBIS PMS)
The purpose of this study is to characterize the safety and describe the effectiveness of RIXUBIS in routine clinical practice.
- Trial name
- NCT03565237
- Testing
- RIXUBIS: On-Demand, RIXUBIS: Prophylaxis
- Where
- India
- Volunteers
- 25 people
- Sponsor
- Baxalta now part of Shire
Prevention of Infectious Disease Caused by SARS-CoV-2
VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Long-term Safety of VAXZEVRIA
This survey will be conducted for the subjects who participate in the priority survey (cohort survey) conducted by the Scientific Research Group of the Ministry of Health, Labour and Welfare at the initial stage of administration…
- Trial name
- NCT05135455
- Where
- 6 sites in Japan
- Volunteers
- 467 people
- Sponsor
- AstraZeneca
Diabetes, Diabetes Mellitus, Type 1
A Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India
This study is conducted in Asia. The aim of the study is to evaluate long term safety and efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine clinical practice in India.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT02117622
- Testing
- insulin degludec
- Where
- 38 sites in India
- Volunteers
- 1,056 people
- Sponsor
- Novo Nordisk A/S
Aneurysm Thoracic, Dissection of Aorta, Thoracic
TBE Zone 2 PMS in Japan
The goal of this surveillance is to confirm the TBE device's safety and efficacy in patients treated with proximal landing in Zone 2 in the post-marketing period.
- Conditions
- Aneurysm Thoracic, Dissection of Aorta, Thoracic, Trauma
- Trial name
- NCT07049913
- Testing
- Gore® TAG® Thoracic Aortic Branch Stent Graft System
- Where
- Japan
- Volunteers
- 200 people
- Sponsor
- W.L.Gore & Associates
SARS-CoV-2
Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE
The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety-related information in South-Korean population.
- Trial name
- NCT06333704
- Testing
- SPIKEVAX Bivalent BA.1, SPIKEVAX Bivalent BA.4/5, SPIKEVAX XBB.1.5
- Where
- 26 sites in South Korea
- Volunteers
- 4,207 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Thromboembolism
PraxbindTM India PMS Program
This program will be initiated after the commercial availability of PraxbindTM in India. It will include patients administered with PraxbindTM into the surveillance program after commercial availability in 2 years at selected…
- Trial name
- NCT03359889
- Testing
- PraxbindTM
- Where
- 3 sites in India
- Volunteers
- 5 people
- Sponsor
- Boehringer Ingelheim
Heart Failure
Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)
Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic heart failure (CHF) under real-world use.
- Trial name
- NCT05262764
- Testing
- JARDIANCE®
- Where
- Japan
- Volunteers
- 1,200 people
- Sponsor
- Boehringer Ingelheim
Hepatocellular Carcinoma
Imjudo & Imfinzi PMS
Based on the re-review of new drugs article, Korean pharmaceutical act, the objectives of this study are to assess safety and effectiveness of the study drugs(Imjudo \& Imfinzi) in a real world setting in patients who treated…
- Trial name
- NCT06544629
- Where
- 6 sites in South Korea
- Volunteers
- 246 people
- Sponsor
- AstraZeneca
Hemophilia A
International PMS Study - KOGENATE Bayer
To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand.
- Trial name
- NCT00864552
- Testing
- Kogenate (BAY14-2222)
- Where
- 10 sites in Austria, Belgium and 8 more
- Volunteers
- 200 people
- Sponsor
- Bayer