Clinical trials: Long Term Results
Microscopic Polyangiitis (MPA), Granulomatosis With Polyangiitis (GPA)
Special Drug Use-results Survey for Long-term Use（Avacopan）
The purpose of this survey is evaluating the safety and efficacy of long-term administration of avacopan for Japanese patients with microscopic polyangiitis or granulomatosis with polyangiitis under actual conditions of use.
- Trial name
- NCT06758271
- Testing
- Avacopan
- Where
- Japan
- Volunteers
- 250 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Growth Hormone Deficiency in Children
Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed
The purpose of the study is to investigate the safety and effectiveness of Sogroya® in children with short stature due to growth hormone deficiency where epiphysial discs are not closed under real-world clinical practice in…
- Trial name
- NCT06109935
- Testing
- Somapacitan
- Where
- 86 sites in Japan
- Volunteers
- 200 people
- Sponsor
- Novo Nordisk A/S
Intervertebral Disc Replacement, Degenerative Disc Disease
Activ C European Multicenter Study
Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who suffer from cervical symptomatic degenerative disc disease. A maximum of 200 cases will be enrolled into the study.
- Trial name
- NCT02492724
- Where
- 10 sites in Czechia, Finland and 3 more
- Volunteers
- 210 people
- Sponsor
- Aesculap AG
Haemophilia A
Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®
The purpose of this study is to assess the safety and effectiveness of Esperoct® for long-term routine use in patients with Haemophilia A. Participants will get Esperoct® as prescribed by their doctor.
- Trial name
- NCT04334057
- Testing
- Turoctocog alfa pegol
- Where
- 20 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Novo Nordisk A/S
Allergic Rhinitis, Asthma
Comparative Real World Effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets vs. Controls in Allergic Rhinitis and Asthma
To assess the impact of SQ SLIT-tablets (SQ Grass SLIT-tablet and SQ HDM SLIT-tablet) in Danish and Swedish allergic rhinitis (AR) patients, with or without asthma, between 2007-2020.
- Conditions
- Allergic Rhinitis, Asthma, Allergy
- Trial name
- RELY (NCT05476484)
- Testing
- SQ SLIT-tablet
- Where
- Denmark
- Volunteers
- 46,196 people
- Sponsor
- ALK-Abelló A/S
Castration-resistant Prostate Cancer
Long-Term Specified Drug Use-Results Survey for Xtandi Capsule
The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in patients.
- Trial name
- NCT02669771
- Testing
- enzalutamide
- Where
- 47 sites in Japan
- Volunteers
- 1,018 people
- Sponsor
- Astellas Pharma Inc
Mixed Hearing Loss
Long Term Results With the Vibrant Soundbridge in Patients With Mixed Hearing Loss: a 60-month Longitudinal Study
Vibrant Soundbridge (VSB, MED-EL, Innsbruck) Active middle ear implants (AMEI) can benefit patients who are unable to use conventional hearing aids (HA) due to medical reasons, discomfort or unsuccessful rehabilitation.
- Trial name
- NCT05793580
- Testing
- Vibrant Soundbridge active middle ear implant
- Where
- France
- Volunteers
- 31 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Plaque-type Psoriasis
Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
- Trial name
- JUNCTURE (NCT01636687)
- Testing
- Secukinumab 150mg, Secukinumab 300mg
- Where
- 39 sites in United States, Canada and 3 more
- Volunteers
- 182 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases), Irritable Bowel Syndrome With Constipation (IBS-C)
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.
- Trial name
- NCT03471728
- Testing
- linaclotide
- Where
- 47 sites in Japan
- Volunteers
- 2,475 people
- Sponsor
- Astellas Pharma Inc
Chronic Kidney Disease, Type 2 Diabetes
An Observational Study Called FLAMINgO to Learn More About the Treatment Combination of Finerenone and SGLT2 Inhibitors in People With Long-term Kidney Disease (Chronic Kidney Disease) Together With Type 2 Diabetes by Using Routine Medical Care Data and Past Clinical Study Results
This is an observational study, in which data from the past of people with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied.
- Trial name
- FLAMINGO (NCT05640180)
- Testing
- Finerenone (Kerendia, BAY94-8862), Sodium-glucose cotransporter-2 inhibitors (SGLT2i)
- Where
- United States
- Volunteers
- 17,847 people
- Sponsor
- Bayer
Nocturia Due to Nocturnal Polyuria
Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet (Nocturia)
To investigate the incidence and risk factors of desmopressin-induced hyponatremia during long-term treatment (1 year [52 weeks]) of MINIRINMELT orally disintegrating (OD) tablets 25μg/50μg (drug) for nocturia caused by nocturnal…
- Trial name
- NOC01 (NCT04329975)
- Testing
- Desmopressin
- Where
- Japan
- Volunteers
- 1,087 people
- Sponsor
- Ferring Pharmaceuticals
Prostate Cancers, Breast Cancer
To Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.
This registry study aims to evaluate the effectiveness and clinical impact of specimen PET-CT imaging by analyzing the correlation between specimen PET-CT images, intraoperative interpretations, and histopathological findings.
- Conditions
- Prostate Cancers, Breast Cancer, Head and Neck Cancer, Cancer
- Trial name
- PETRiS (NCT06970275)
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 850 people
- Sponsor
- XEOS Medical
Haemophilia A, Haemophilia B
Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo
The purpose of the study is to investigate the safety and effectiveness of Alhemo in participants under real-world clinical practice in Japan. Total duration of this study is about 6 years.
- Trial name
- NCT06831734
- Testing
- Concizumab
- Where
- 23 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Novo Nordisk A/S
Long Term Safety of the AMS 1.0
PROGRESS-AMS 1.0 Clinical Long Term Follow-Up
The primary objective of this study is to collect long term clinical follow-up data on all patients enrolled in the PROGRESS AMS-1.0 study to assess long term safety of the AMS-1.0
- Trial name
- NCT01610102
- Where
- 6 sites in Australia, Belgium and 3 more
- Volunteers
- 55 people
- Sponsor
- Biotronik AG
Hidradenitis Suppurativa (HS)
Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa
The objective of this study is to evaluate the long-term safety and effectiveness of Humira in patients with Hidradenitis Suppurativa (HS) in real-world clinical practice in Japan.
- Trial name
- NCT03894956
- Where
- 37 sites in Japan
- Volunteers
- 46 people
- Sponsor
- AbbVie
Secondary Progressive Multiple Sclerosis (SPMS)
Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients
This study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using Mayzent for the indication of secondary progressive multiple sclerosis.
- Trial name
- NCT04593927
- Testing
- Mayzent
- Where
- 174 sites in Japan
- Volunteers
- 451 people
- Sponsor
- Novartis Pharmaceuticals
Overactive Bladder
Long-Term Specified Drug Use-results Survey of Betanis Tablets
This study is to evaluate the safety and efficacy of long-term use of Betanis (generic name: mirabegron), and to determine the adherence to treatment with mirabegron.
- Trial name
- NCT01901120
- Testing
- Betanis
- Where
- 8 sites in Japan
- Volunteers
- 1,263 people
- Sponsor
- Astellas Pharma Inc
Diabetes, Diabetes Mellitus, Type 2
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results
This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.
- Trial name
- LEADER® (NCT01179048)
- Testing
- liraglutide
- Where
- 428 sites in United States, Australia and 31 more
- Volunteers
- 9,341 people
- Sponsor
- Novo Nordisk A/S
Adult Growth Hormone Deficiency
Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®
Participants are invited to take part in this study because they have AGHD (only severe case). The purpose of this study is to assess long term safety and effectiveness of Sogroya® in patients with AGHD (only severe case) under…
- Trial name
- NCT05230550
- Testing
- Somapacitan
- Where
- 47 sites in Japan
- Volunteers
- 200 people
- Sponsor
- Novo Nordisk A/S
Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis
A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia
This study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting.
- Trial name
- NCT02159651
- Testing
- tacrolimus
- Where
- 8 sites in Japan
- Volunteers
- 179 people
- Sponsor
- Astellas Pharma Inc