Clinical trials: Surveillance
Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis
Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients
The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.
- Trial name
- NCT01901107
- Testing
- Kiklin capsules
- Where
- 8 sites in Japan
- Volunteers
- 1,078 people
- Sponsor
- Astellas Pharma Inc
Rheumatoid Arthritis
Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan
The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives…
- Trial name
- NCT00503139
- Testing
- Enbrel (etanercept)
- Where
- Japan
- Volunteers
- 684 people
- Sponsor
- Pfizer
Prostate Cancer
Long-Term Prospective Registry in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing
This registry will evaluate treatment selection for patients with newly diagnosed, localized prostate cancer following Prolaris testing.
- Trial name
- NCT04404894
- Where
- 7 sites in United States
- Volunteers
- 500 people
- Sponsor
- Myriad Genetic Laboratories, Inc.
Prostate Cancer
A Study to Evaluate the Safety, Tolerability and Efficacy of a Liproca® Depot Injection in Patients With Prostate Cancer
A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection into the Prostate in Patients with Localized Prostate Cancer,Assigned to Active Surveillance who…
- Trial name
- NCT03348527
- Testing
- 2-Hydroxyflutamide Depot
- Where
- 10 sites in Canada, Finland and 1 more
- Volunteers
- 61 people
- Sponsor
- Lidds AB
Influenza
A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older
This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women aged 65 years and older.
- Trial name
- NCT01222403
- Testing
- Fluad_MF59-adjuvanted trivalent influenza subunit vaccine, Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine
- Where
- 23 sites in South Korea
- Volunteers
- 767 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Breast Neoplasms
A Study of Trastuzumab Subcutaneous in Participants With Human Epidermal Growth Factor Receptor-2 (HER2) Positive Early Breast Cancer
This observational study will evaluate the efficacy, safety, tolerability and participant reported quality of life of trastuzumab (Herceptin) subcutaneous (SC) therapy in participants with HER2-positive early breast cancer in…
- Trial name
- HerSCin (NCT01959386)
- Testing
- Trastuzumab
- Where
- Germany
- Volunteers
- 1,006 people
- Sponsor
- Hoffmann-La Roche
Heart Failure
Jardiance® Post Marketing Surveillance (PMS) in Korean Patients With Chronic Heart Failure
The primary objective of this study is to monitor the safety profile of Jardiance® in Korean patient with chronic heart failure (New York Heart Association (NYHA) class II-IV) in a routine clinical setting.
- Trial name
- NCT05236673
- Testing
- JARDIANCE®
- Where
- 21 sites in South Korea
- Volunteers
- 676 people
- Sponsor
- Boehringer Ingelheim
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning
Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02866266
- Testing
- Retrospective database review
- Volunteers
- 183,452 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
MR Mammography With Dotarem
Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography
Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine) from September 2011 to December 2013.
- Trial name
- NCT03041298
- Testing
- MR mammography with Dotarem
- Volunteers
- 1,537 people, healthy volunteers welcome
- Sponsor
- Guerbet
Cytomegalovirus (CMV)
A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection
This study is a survey in Japan of Maribavir tablets used to treat participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell…
- Trial name
- NCT06577363
- Testing
- Maribavir
- Where
- Japan
- Volunteers
- 250 people
- Sponsor
- Takeda
Contraceptive; Complications, Intrauterine
Surveillance Study of the Contraceptive Intrauterine Device UT380®
The study is a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method.
- Trial name
- CCDDIUUT (NCT03642171)
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Quanta Medical
Paroxysmal Nocturnal Hemoglobinuria
Specified Drug-use Surveillance of Fabhalta Capsules
This is a multicenter, single-arm, non-interventional study (NIS) with a central registration system and an all-case surveillance system. The observation period is 48 weeks after the start of treatment with Fabhalta.
- Trial name
- NCT06606314
- Where
- 91 sites in Japan
- Volunteers
- 132 people
- Sponsor
- Novartis Pharmaceuticals
Lymphoma, Non-Hodgkin, Lymphocytic Leukemia
Symbenda Post-Marketing Surveillance (PMS)
This is a PMS of Symbenda Injection (bendamustine hydrochloride) in Korean Patients. The main objective is to obtain safety information related to Symbenda treatment from clinical practice.
- Conditions
- Lymphoma, Non-Hodgkin, Lymphocytic Leukemia, Multiple Myeloma
- Trial name
- NCT02434484
- Where
- 9 sites in South Korea
- Volunteers
- 84 people
- Sponsor
- Eisai Korea Inc.
Diarrhea-predominant Irritable Bowel Syndrome
Special Drug Use Surveillance of Irribow in Female Patients
The purpose of the survey is to evaluate the safety and efficacy of Irribow and Irribow OD Tablets in post-marketing medical practice and to examine the status of treatment compliance.
- Trial name
- NCT02612649
- Testing
- Ramosetron
- Where
- 34 sites in Japan
- Volunteers
- 793 people
- Sponsor
- Astellas Pharma Inc
Hypertension, Dyslipidemias
Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy
Post-marketing surveillance of Telostop TAB (Telmisartan/Rosuvastatin)
- Trial name
- NCT03742544
- Volunteers
- 600 people
- Sponsor
- IlDong Pharmaceutical Co Ltd
Pediatric Crohn's Disease
Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"
This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea.
- Trial name
- NCT02578238
- Volunteers
- 143 people
- Sponsor
- AbbVie
Generalized Pustular Psoriasis
Spesolimab Post-marketing Surveillance in Korean Patients With Flares With Generalized Pustular Psoriasis
The primary and secondary objectives are to respectively monitor the safety and effectiveness of Spesolimab IV in Korean patients with flares with generalized pustular psoriasis (GPP) in a routine medical practice.
- Trial name
- NCT06886009
- Testing
- Spevigo®
- Where
- 4 sites in South Korea
- Sponsor
- Boehringer Ingelheim
Rhinitis, Urticaria
Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria
Eligible patients will be prescribed Desloratadine 1 tablet of 5 mg once daily. Patients will be asked to follow-up for a final visit after 14 days (Day 15) where the safety, tolerability and clinical efficacy will be measured.
- Trial name
- Aerius (NCT00724698)
- Testing
- Desloratadine
- Volunteers
- 3,011 people
- Sponsor
- Organon and Co
Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)
Calquence CLL rr Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - All Patient Investigation
To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing…
- Trial name
- NCT04872621
- Where
- 59 sites in Japan
- Volunteers
- 104 people
- Sponsor
- AstraZeneca
Abdominal Aneurysm
AneuRx Post Market Study in the Treatment of AAA
The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta.
- Trial name
- NCT00604552
- Testing
- AneuRx Stent Graft
- Where
- 8 sites in United States
- Volunteers
- 349 people
- Sponsor
- Medtronic Cardiovascular
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