Clinical trials: Surveillance
Chronic Heart Failure
Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
Medtronic is sponsoring the Apogee study to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation/ antiplatelet therapy in patients receiving a Medtronic…
- Trial name
- NCT03697980
- Testing
- HeartWare Ventricular Assist Device
- Where
- 33 sites in United States
- Volunteers
- 136 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bleeding, Surgical Wound
Traumacel FAM Trium in the Post-market Surveillance Phase
The investigational medical device Traumacel FAM Trium is a sterile plant polysaccharide haemostatic agent based on the oxidized cellulose in the form of multilayer nonwoven fabric.
- Trial name
- NCT05177874
- Testing
- Traumacel FAM Trium, Surgicel Fibrillar
- Where
- Czechia
- Volunteers
- 98 people
- Sponsor
- Bioster, a.s.
Hemophilia A
Study Evaluating The Safety Of Xyntha In Usual Care Settings
The purpose of this study is to collect safety information associated with the use of Xyntha in a usual care setting. Upon meeting eligibility criteria, patients will be required to have approximately 5 study visits over a 2 year…
- Trial name
- NCT00765726
- Testing
- Moroctocog alfa(AF-CC), Blood draw for laboratory testing
- Where
- 6 sites in United States, New Zealand
- Volunteers
- 12 people
- Sponsor
- Pfizer
Stroke, PFO - Patent Foramen Ovale
Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.
- Conditions
- Stroke, PFO - Patent Foramen Ovale, Cryptogenic Stroke, TIA
- Trial name
- GSO-PFO PMS (NCT05529901)
- Testing
- GORE® CARDIOFORM Septal Occluder
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- W.L.Gore & Associates
Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma
Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"
The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for intravenous (IV) infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large…
- Trial name
- NCT02139592
- Testing
- Brentuximab vedotin (recombinant)
- Where
- Japan
- Volunteers
- 292 people
- Sponsor
- Takeda
Ischemic Heart Disease, Angina Pectoris
Absorb GT1 Japan PMS
The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for…
- Conditions
- Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion
- Trial name
- NCT03409731
- Testing
- ABSORB GT1 BVS
- Where
- 15 sites in Japan
- Volunteers
- 135 people
- Sponsor
- Abbott Medical Devices
Type 2 Diabetes Mellitus
Pioglitazone Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"
The purpose of this survey is to determine the onset of new cerebral and cardiovascular events and changes in metabolic syndrome parameters in patients with type 2 diabetes mellitus on long-term pioglitazone (Actos Tablets)…
- Trial name
- NCT02002975
- Testing
- Pioglitazone
- Volunteers
- 18,223 people
- Sponsor
- Takeda
Hepatitis C
An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
Post-marketing surveillance study to evaluate the real world safety and effectiveness of Maviret (Glecaprevir/Pibrentasvir) administered under a normal, routine treatment practice by Korean patients with Chronic Hepatitis C…
- Trial name
- Maviret PMS (NCT03740230)
- Where
- 61 sites in South Korea
- Volunteers
- 3,134 people
- Sponsor
- AbbVie
Peripheral Neuropathic Pain
Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets
This is an open-label, non-comparative, non-interventional, prospective, and multi-center PMS study to observe safety and effectiveness of Lyrica CR (82.5mg, 165mg, 330mg) in Korean subjects under the actual condition of use.
- Trial name
- NCT04171453
- Testing
- Lyrica CR (Pregabalin)
- Where
- 3 sites in South Korea
- Volunteers
- 600 people
- Sponsor
- Viatris Korea
HIV-1 Infection
Surveillance of Kaletra in Korean Patients
This single-arm, multi-center, Post-Marketing Surveillance study of Kaletra (lopinavir/ritonavir) was conducted in accordance with the approved Korean product labeling in participants 2 years of age and older with human…
- Trial name
- NCT01083173
- Volunteers
- 595 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Chronic Myeloid Leukemia, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Iclusig PMS in CML or Ph+ALL Patients
This is a Post-Marketing Surveillance (PMS) of Iclusig® Tablets in accordance with Korean regulations on Risk Management Plan (RMP).
- Trial name
- NCT03709017
- Testing
- Ponatinib
- Where
- South Korea
- Volunteers
- 50 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Immune Surveillance
EpiCor Clinical Study on Rapid Immune Modulating Effects
Clinical verification study evaluating the effects of a nutraceutical product. This study involves thirty participants composed of healthy adults, who will be taking either a placebo or nutraceutical supplement at different…
- Trial name
- NCT05819424
- Testing
- Yeast Fermentate (EpiCor)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cargill
Schizophrenia, Bipolar 1 Disorder
Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder
This is a Post-Marketing Surveillance (PMS) of Abilify Maintena® Injections in accordance with Korean regulations on New Drug Re-examination (i.e.
- Trial name
- NCT03386851
- Where
- South Korea
- Volunteers
- 1,030 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Dyslipidemias
Post Marketing Surveillance of Safety and Efficacy for Cholib in Korean Patients Under the "New Drug Re-examination".
Post marketing surveillance of safety and efficacy for Cholib in Korean patients under the "New Drug Re-examination"
- Trial name
- NCT02489331
- Where
- 10 sites in South Korea
- Volunteers
- 193 people
- Sponsor
- Abbott
Rheumatoid Arthritis, Psoriatic Arthritis
A Study to Assess the Safety and Effectiveness of Golimumab in Filipino Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
The purpose of this study is to assess the safety and effectiveness of golimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among Filipino patients.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
- Trial name
- NCT01692457
- Testing
- No intervention
- Sponsor
- Janssen Pharmaceutica
Contraception, Premenstrual Syndrome
Regulatory Post Marketing Surveillance Study on YAZ
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.
- Conditions
- Contraception, Premenstrual Syndrome, Acne
- Trial name
- NCT00998257
- Testing
- EE20/DRSP (YAZ, BAY86-5300)
- Where
- South Korea
- Volunteers
- 770 people
- Sponsor
- Bayer
Coronary Artery Disease
CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)
The purpose of this PMS registry, named e-CYPHER Stent Registry, is to collect post marketing surveillance data on the CYPHERTM Sirolimus-eluting Coronary Stent following marketing approval, when used in normal clinical practice…
- Trial name
- NCT00245401
- Testing
- CYPHERTM Sirolimus-Eluting Coronary Stent
- Volunteers
- 2,070 people
- Sponsor
- Cordis US Corp.
Multiple Myeloma
A Study to Evaluate the Long-Term Safety of Idecabtagene Vicleucel Treatment in Adults With Newly Diagnosed Multiple Myeloma in Korea
The purpose of this study is to monitor the long-term safety of participants who received idecabtagene vicleucel treatment as part of the KarMMa-9 (CA089-1043) Phase 3 clinical trial.
- Trial name
- NCT06698887
- Testing
- Idecabtagene vicleucel
- Where
- 5 sites in South Korea
- Volunteers
- 15 people
- Sponsor
- Bristol-Myers Squibb
Prostate Cancer
Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"
The purpose of this study is to evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.
- Trial name
- NCT03209492
- Testing
- Leuprorelin acetate
- Where
- Japan
- Volunteers
- 333 people
- Sponsor
- Takeda
Haemophilia A, Haemophilia B
Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors
The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor.
- Trial name
- NCT06285071
- Testing
- Concizumab
- Where
- 11 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Novo Nordisk A/S
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