Clinical trials: Surveillance
Thrombotic Thrombocytopenic Purpura (TTP)
A Survey of Recombinant ADAMTS13 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
This study is a survey in Japan of recombinant ADAMTS13 used to treat or to prevent participants with congenital thrombotic thrombocytopenic purpura (cTTP).
- Trial name
- NCT06441578
- Testing
- Recombinant ADAMTS13
- Where
- Japan
- Volunteers
- 40 people
- Sponsor
- Takeda
Neovascular Age-related Macular Degeneration
Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration.
An open label, non-comparative, multicenter, non-interventional, post marketing surveillance study to evaluate the overall safety and tolerability of pegaptanib sodium(Macugen) in the treatment of Filipino patients with…
- Trial name
- NCT00820742
- Testing
- Macugen
- Sponsor
- Pfizer
Kidney Disease, Chronic
JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD)
The primary objective is to monitor the safety profile of JARDIANCE® in Korean patient with chronic kidney disease (CKD) in routine clinical practice.
- Trial name
- NCT06287073
- Testing
- JARDIANCE®
- Where
- 12 sites in South Korea
- Volunteers
- 299 people
- Sponsor
- Boehringer Ingelheim
Hepatitis C Virus
Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
The objectives of this study are to collect and assess data related to safety and effectiveness of Sovaldi treatment regimens, per the approved prescribing information for Sovaldi, in routine clinical practice and report results…
- Trial name
- NCT02907996
- Testing
- Sofosbuvir
- Where
- 72 sites in South Korea
- Volunteers
- 2,033 people
- Sponsor
- Gilead Sciences
Intervertebral Disc Degeneration, Spinal Fusion
A Post Market Surveillance on INFUSE Bone Graft
This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.
- Conditions
- Intervertebral Disc Degeneration, Spinal Fusion, Lumbar Disc Disease
- Trial name
- NCT05299762
- Testing
- INFUSE™ Bone Graft
- Where
- South Korea
- Volunteers
- 600 people
- Sponsor
- Medtronic Spinal and Biologics
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
Paroxysmal Nocturnal Hemoglobinuria, C3 Glomerulopathy
A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
This is a post-marketing surveillance study conducted as part of the Risk Management Plan (RMP) for South Korea, to evaluate the safety and effectiveness of iptacopan in real-world clinical settings for the treatment of either…
- Trial name
- NCT07416162
- Where
- 3 sites in South Korea
- Volunteers
- 21 people
- Sponsor
- Novartis Pharmaceuticals
Renal Cell Carcinoma, Hepatocellular Carcinoma
Post-marketing Surveillance on the Safety of CabometyxTM in Korean Patients
The objective of this Post Marketing Surveillance (PMS) is to collect and describe safety and effectiveness profile of Cabometyx™ in real clinical practice setting, according to the approved labelling after the approval of…
- Conditions
- Renal Cell Carcinoma, Hepatocellular Carcinoma, Differentiated Thyroid Carcinoma
- Trial name
- NCT03776123
- Where
- 47 sites in South Korea
- Volunteers
- 347 people
- Sponsor
- Ipsen
Psoriasis
Post-Marketing Surveillance Study of Adalimumab in Pediatric Chronic Severe Plaque Psoriasis Patients in Korea
The objective of this study is to evaluate the real world safety and effectiveness of adalimumab (Humira) for the treatment of Korean patients with pediatric chronic severe plaque psoriasis under a routine treatment practice.
- Trial name
- ped PsO rPMS (NCT03925441)
- Where
- South Korea
- Volunteers
- 2 people
- Sponsor
- AbbVie
Multiple Myeloma
Postmarketing Study of Empliciti in Korean Patients With Multiple Myeloma
This study is a regulatory postmarketing surveillance study for Empliciti with a representative sample of the overall Korean multiple myeloma (MM) population.
- Trial name
- NCT03660072
- Testing
- Non-Interventional
- Where
- South Korea
- Sponsor
- Bristol-Myers Squibb
Erectile Dysfunction
Vardenafil Treatment Of Erectile Dysfunction In Depressive And Non-Depressive Men
The primary aim of this open, uncontrolled, prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction.
- Trial name
- NCT00470873
- Testing
- Levitra (Vardenafil, BAY38-9456)
- Where
- Poland
- Volunteers
- 2,471 people
- Sponsor
- Bayer
End Stage Renal Disease
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized…
- Trial name
- NCT06516653
- Testing
- VasQ, Arteriovenous fistula creation for dialysis vascular access
- Where
- 13 sites in United States
- Volunteers
- 300 people
- Sponsor
- Laminate Medical Technologies
Ventilator Associated Pneumonia
A Multi-Center Observational Surveillance Study of VAP Causing Bacteria
Detect the clinical causitive pathogen of Ventilator Associated Pneumonia (VAP) patients by the bronchoalveolar lavage (BAL) method.
- Trial name
- NCT00484588
- Volunteers
- 500 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hypertension
Assessment of Compliance With Antihypertensive Telmisartan Therapy
The purpose of this study is to asses the efficacy and safety of Telmisartan depending on the use of an electronic therapy monitoring device (HelpingHand) in a real life setting and to asses patients compliance to the therapy…
- Trial name
- COAST (NCT00470886)
- Testing
- Telmisartan (Kinzal/Pritor, BAY68-9291)
- Where
- 2 sites in Poland, Slovakia
- Volunteers
- 3,400 people
- Sponsor
- Bayer
Folate Receptor-Alpha Positive Platinum-Resistant High-Grade Serous Epithelial Ovarian Cancer, Folate Receptor-Alpha Positive Platinum-Resistant Fallopian Tube Cancer
A Study to Evaluate Adverse Events and Change in Disease Activity of Mirvetuximab Soravtansine-gynx in Adults With Folate Receptor-Alpha Positive, Platinum-Resistant Ovarian Cancer in a Real-World Setting
Epithelial ovarian cancer, which includes fallopian tube and primary peritoneal cancers, is a lethal disease with 3,221 new cases reported in 2021 in Korea.
- Conditions
- Folate Receptor-Alpha Positive Platinum-Resistant High-Grade Serous Epithelial Ovarian Cancer, Folate Receptor-Alpha Positive Platinum-Resistant Fallopian Tube Cancer, Folate Receptor-Alpha Positive Platinum-Resistant Primary Peritoneal Cancer
- Trial name
- NCT07687602
- Volunteers
- 69 people
- Sponsor
- AbbVie
Osteoporosis
BONVIVA(Ibandronate) Injection PMS(Post-marketing Surveillance)
This is an open label, multi-centre, non-interventional post-marketing surveillance
- Trial name
- BONINJPMS (NCT01376102)
- Testing
- BONVIVA(ibandronate) injection
- Where
- South Korea
- Volunteers
- 657 people
- Sponsor
- GlaxoSmithKline
Hip Osteoarthritis
Assess the Mid-term Performance of the Mpact Cup in Subjects Requiring Total Hip Arthroplasty
Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.
- Trial name
- NCT03897595
- Testing
- MPact Cup
- Where
- 5 sites in United States
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- Medacta USA
Contraception
Yasmin Post Marketing Surveillance
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.
- Trial name
- NCT00923572
- Testing
- EE30/DRSP (Yasmin, BAY86-5131)
- Where
- South Korea
- Volunteers
- 777 people
- Sponsor
- Bayer
Serious Fungal Infections
Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea
This is a non-interventional study of voriconazole tablet in Korea which is mandated by the Korean government agency.
- Trial name
- NCT01073631
- Testing
- voriconazole tablet
- Volunteers
- 543 people
- Sponsor
- Pfizer
Chronic Hepatitis C
Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
The primary objective of this study is: To evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in Japanese patients chronically infected with HCV…
- Trial name
- NCT02250001
- Where
- Japan
- Volunteers
- 2,974 people
- Sponsor
- Bristol-Myers Squibb