Clinical trials: Surveillance
Infertility, Female
A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
This observational study will examine the safety and efficacy profile of Elonva (corifollitropin alfa) when administered in Korean women undergoing controlled ovarian stimulation (COS) in combination with a gonadotropin-releasing…
- Trial name
- NCT01408615
- Testing
- corifollitropin alfa
- Volunteers
- 472 people
- Sponsor
- Organon and Co
Rheumatoid Arthritis (RA), Atopic Dermatitis (AD)
A Study of Oral Upadacitinib (RINVOQ) Tablets to Assess Adverse Events and Change in Disease Symptoms in Korean Participants With Moderate to Severe Active Rheumatoid Arthritis, Atopic Dermatitis, Ankylosing Spondylitis or Psoriatic Arthritis
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints characterized by the swelling of multiple joints and tenderness caused by progressive inflammatory synovitis, which leads to serious and debilitating diseases.
- Conditions
- Rheumatoid Arthritis (RA), Atopic Dermatitis (AD), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA)
- Trial name
- NCT04541810
- Where
- 116 sites in South Korea
- Volunteers
- 2,369 people
- Sponsor
- AbbVie
Relapsed or Refractory Multiple Myeloma
A Study to Evaluate the Safety of Empliciti® (Elotuzumab) When Treating Patients With Multiple Myeloma in Taiwan
This observational study aimed to assess the safety of elotuzumab when used in combination with pomalidomide and dexamethasone for the treatment of relapsed and refractory multiple myeloma (RRMM) in participants who had received…
- Trial name
- NCT06163040
- Testing
- Elotuzumab in combination with pomalidomide and dexamethasone, Elotuzumab in combination with lenalidomide and dexamethasone
- Where
- 4 sites in Taiwan
- Volunteers
- 7 people
- Sponsor
- Bristol-Myers Squibb
Full Thickness Rotator Cuff Tear
BioFiber Scaffold Post-Market Observational Study
The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.
- Trial name
- NCT01849458
- Testing
- BioFiber
- Where
- 3 sites in United States, France
- Volunteers
- 50 people
- Sponsor
- Stryker Trauma and Extremities
Moderate-to-severe Plaque Psoriasis
Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea
The purpose of this observational study is to describe the safety and effectiveness of deucravacitinib in participants in Korea that have been diagnosed with moderate-to-severe plaque psoriasis.
- Trial name
- NCT06258668
- Testing
- Deucravacitinib
- Where
- 2 sites in South Korea
- Volunteers
- 505 people
- Sponsor
- Bristol-Myers Squibb
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.
Partial Onset Seizures, Epilepsy
A Study to Assess Safety and Efficacy of Perampanel in Indian Participants as an Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Participants With Epilepsy Aged 12 Years or Older
The purpose of this study is to assess the safety of perampanel in the treatment of partial onset seizures in participants of age 12 years and older with epilepsy.
- Trial name
- NCT03836924
- Testing
- Perampanel
- Where
- 12 sites in India
- Volunteers
- 200 people
- Sponsor
- Eisai Pharmaceuticals India Pvt. Ltd
Carcinoma, Renal Cell
Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC).
- Trial name
- NCT01411423
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- Japan
- Volunteers
- 3,305 people
- Sponsor
- Bayer
Neoplasms, Rectal
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea
The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30…
- Trial name
- NCT03671369
- Testing
- Safety data collection (following routine vaccination) by a continuous surveillance method.
- Where
- 29 sites in South Korea
- Volunteers
- 670 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cancer
Regulatory TYKERB® Tablets PMS
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information TYKERB® is…
- Trial name
- NCT00975988
- Testing
- TYKERB® tablets
- Where
- 2 sites in South Korea
- Volunteers
- 750 people
- Sponsor
- GlaxoSmithKline
Breast Cancer
Observational Study of Pertuzumab Safety in Participants With Breast Cancer
This Phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) will evaluate the safety of pertuzumab in approximately 1000 participants with metastatic or locally unresectable…
- Trial name
- NCT02266173
- Testing
- Pertuzumab
- Where
- 37 sites in South Korea
- Volunteers
- 1,130 people
- Sponsor
- Hoffmann-La Roche
Angina, Coronary Occlusion
XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and…
- Conditions
- Angina, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis
- Trial name
- NCT01721096
- Testing
- XIENCE PRIME - Long Length (LL), XIENCE PRIME - Core Size
- Where
- Japan
- Volunteers
- 536 people
- Sponsor
- Abbott Medical Devices
Inflammatory Bowel Diseases, Colitis, Ulcerative
A Study of Kynteles Injection (Vedolizumab) in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease or Chronic Pouchitis
In this study, participants with ulcerative colitis or Crohn's disease or pouchitis will be treated with Kynteles injection (Vedolizumab) according to their clinic's standard practice.
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- Trial name
- NCT04799496
- Where
- 43 sites in South Korea
- Volunteers
- 688 people
- Sponsor
- Takeda
Aspergillosis, Mucormycosis
Post Marketing Surveillance (PMS) Study of Cresemba in Korea.
The purpose of this study is to observe safety and effectiveness of Cresemba in patients with invasive Aspergillosis or invasive Mucormycosis in Korea during the post-marketing surveillance period as required by Ministry of Food…
- Trial name
- NCT04744454
- Testing
- Isauvuconazole group
- Where
- South Korea
- Volunteers
- 94 people
- Sponsor
- Pfizer
Dengue Fever, Fever
Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Asia
The purpose of this study is to detect acute febrile episodes and dengue infection in five Asian countries, to assess dengue seroprevalence, and to assess surveillance infrastructure at investigational sites in anticipation of a…
- Trial name
- NCT01218906
- Where
- 11 sites in Indonesia, Malaysia and 3 more
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Sanofi
Serious Fungal Infections
Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea.
- Trial name
- NCT01073618
- Testing
- voriconazole IV
- Volunteers
- 692 people
- Sponsor
- Pfizer
Diabetes, Diabetes Mellitus, Type 1
Post Marketing Surveillance Study of Biphasic Insulin Aspart 30
This study is conducted in Asia. The aim of this study is to review the safety and efficacy of biphasic insulin aspart 30 in post-marketing use.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT01536613
- Testing
- biphasic insulin aspart 30
- Where
- South Korea
- Volunteers
- 5,346 people
- Sponsor
- Novo Nordisk A/S
Vancomycin Resistance Enterococcus Faecium
Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)
To collect the efficacy and safety information in subjects who have been treated with Zyvox (linezolid) for vancomycin resistance Enterococcus faecium infection for their appropriate use in daily practice.
- Trial name
- NCT01224626
- Testing
- Zyvox (linezolid)
- Volunteers
- 41 people
- Sponsor
- Pfizer
Hypertension, Pulmonary
Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension
The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol inhalation therapy in patients suffering from pulmonary hypertension.
- Trial name
- NCT00185315
- Testing
- Ventavis (Iloprost, BAYQ6256)
- Where
- 16 sites in Belgium, France and 5 more
- Volunteers
- 71 people
- Sponsor
- Bayer
Pulmonary Disease, Chronic Obstructive
Postmarketing Surveillance Study of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease
To obtain further information on the tolerability and efficacy of Atrovent® inhalets in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice
- Trial name
- NCT02238171
- Testing
- Atrovent® inhalets
- Volunteers
- 346 people
- Sponsor
- Boehringer Ingelheim
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