Clinical trials: Long-term Outcomes
Phenylketonuria
Kuvan®'s Effect on the Cognition of Children With Phenylketonuria
The study is a single-cohort, interventional, open-label trial to evaluate long-term neurocognitive (NC) outcomes in children aged 4 to 5 years with phenylketonuria (PKU) treated with Kuvan® and Phenylalanine-restricted diet over…
- Trial name
- KOGNITO (NCT01965912)
- Testing
- Kuvan®
- Where
- 12 sites in Germany, Italy and 2 more
- Volunteers
- 34 people
- Sponsor
- BioMarin Pharmaceutical
Progressive Familial Intrahepatic Cholestasis
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea
This study will collect information from people with Progressive Familial Intrahepatic Cholestasis (PFIC) as they use odevixibat in their daily lives.
- Trial name
- NCT07185919
- Where
- 5 sites in South Korea
- Volunteers
- 10 people
- Sponsor
- Ipsen
Nonmelanoma Skin Cancer
Comparison of eBX and Mohs Surgery for Treatment of Early-stage Non-melanoma Skin Cancer a Matched Pair Cohort Study.
This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record…
- Trial name
- NCT03024866
- Testing
- Electronic Brachytherapy
- Where
- 4 sites in United States
- Volunteers
- 369 people
- Sponsor
- Xoft, Inc.
Heart Disease
PULSTA TPV Observational Study
The purpose of the study is to determine the long-term follow-up clinical outcomes, effectiveness, and safety data of the PULSTA Transcatheter Pulmonary Valve (TPV) implantation in a real-world situation
- Trial name
- NCT07747207
- Where
- 9 sites in Germany, Italy and 4 more
- Volunteers
- 200 people
- Sponsor
- Taewoong Medical Co., Ltd.
Phenylketonuria
A Study of Sepiapterin in Participants With Phenylketonuria (PKU)
The main purpose of this trial is to evaluate the long-term efficacy of sepiapterin on preserving neurocognitive functioning in children with PKU when treatment is initiated in early childhood.
- Trial name
- EPIPHENY (NCT06302348)
- Testing
- Sepiapterin
- Where
- 14 sites in United States, Australia and 5 more
- Volunteers
- 56 people
- Sponsor
- PTC Therapeutics
Chronic Rhinosinusitis With Nasal Polyposis
Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
The primary objectives of the study are: To longitudinally characterize the long-term effectiveness of DUPIXENT® through assessment of patient-reported symptoms, Health-Related Quality of Life (HRQoL) related to Chronic…
- Trial name
- AROMA (NCT04959448)
- Testing
- DUPIXENT®
- Where
- 81 sites in United States, Canada and 4 more
- Volunteers
- 717 people
- Sponsor
- Regeneron Pharmaceuticals
Diabetes Mellitus, Type 2
Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications
This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping patients with high lab values of glucose from progressing to frank diabetes and developing cardiovascular…
- Trial name
- Navigator (NCT00097786)
- Testing
- Valsartan 160 mg + nateglinide 60 mg
- Where
- 38 sites in United States, Argentina and 36 more
- Volunteers
- 9,306 people
- Sponsor
- Novartis Pharmaceuticals
Wilson Disease
Study to Assess Long-Term Outcomes of Trientine in Wilson Disease Patients Withdrawn From Therapy With d-Penicillamine
A study to review Wilson disease patients who have previously been prescribed d- Penicillamine but were changed to trientine as treatment for their disease, and to follow them for a further 12 months.
- Trial name
- NCT02426905
- Testing
- trientine dihydrochloride
- Where
- 4 sites in Germany, Greece and 2 more
- Volunteers
- 90 people
- Sponsor
- Univar BV
Wet Age-related Macular Degeneration (wAMD)
Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word（STONE）
This is a post-marketing drug safety monitoring study in a prospective manner, and data collection will be performed in a registration-follow-up manner.
- Trial name
- NCT03054818
- Where
- 49 sites in China
- Volunteers
- 4,000 people
- Sponsor
- Chengdu Kanghong Biotech Co., Ltd.
Hunter Syndrome, Mucopolysaccharidosis II (MPS II)
Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase
Study TKT024EXT was a long-term, single-arm, open-label extension of Study TKT024, a one year Phase 2/Phase 3 registration study.
- Trial name
- NCT00630747
- Testing
- Idursulfase
- Where
- 52 sites in United States, Brazil and 8 more
- Volunteers
- 94 people
- Sponsor
- Shire
Prostate Cancer
Long-term Study to Evaluate and Clinical Outcomes in Patients With Favorable Intermediate Risk Localized Prostate Cancer
This is a long-term prospective registry study to determine whether Prolaris testing in patients with favorable intermediate risk prostate cancer influences physician management decisions toward conservative treatment in patients…
- Trial name
- NCT03290508
- Testing
- Prolaris Testing
- Where
- 34 sites in United States
- Volunteers
- 524 people
- Sponsor
- Myriad Genetic Laboratories, Inc.
Lumbar Spinal Stenosis
Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP®
The Long-Term Outcomes Study (LTOS) is a multi-center longitudinal cohort study of all patients who received the X-STOP device in the Pivotal Trial, Continued Access Protocol (CAP), or Cross-over Study (COS).
- Trial name
- NCT00534092
- Testing
- X STOP® Interspinous Process Decompression System
- Where
- 5 sites in United States
- Volunteers
- 69 people
- Sponsor
- Medtronic Spine LLC
Opioid Use Disorder, Relapse
Clinical Outcomes Following Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention: A Long-term Follow-up Study
This is a prospective, observational, longitudinal study to assess clinical outcomes in the 12-months following participants' exit from protocol SBM-OWP-03, Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse…
- Trial name
- RESTOREb (NCT05591703)
- Testing
- Clinical Outcomes and Questionnaires
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- Spark Biomedical, Inc.
Opioid Use Disorder
SUBLOCADE Long-term Outcomes
This study will provide the opportunity to generate data on the long-term use of SUBLOCADE under real-world conditions, and to observe enduring changes in lifestyle, health, and sociodemographic factors that are part of the…
- Trial name
- NCT05860959
- Where
- 49 sites in United States, Australia and 2 more
- Volunteers
- 480 people
- Sponsor
- Indivior Inc.
Solid Tumor Malignancy, Breast Cancer
Ataraxis Real-World Clinical Outcomes Registry Linking AI-Based Pathology Scores to Patient Outcomes
The ARC Registry is a large-scale, multi-site, prospective, observational registry. All patients with a solid tumor malignancy who receive Ataraxis testing as part of routine clinical care are eligible for enrollment, which will…
- Trial name
- ARC (NCT07706842)
- Testing
- Ataraxis testing
- Volunteers
- 1,000 people
- Sponsor
- Ataraxis AI, Inc.
Growth Disorders
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Sweden
This is a Swedish, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment to assess the level of…
- Trial name
- ECOS SWE (NCT01307059)
- Testing
- easypod™
- Where
- 3 sites in Sweden
- Volunteers
- 152 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hepatitis B
A Phase IIIb: Long-Term Outcomes for Hepatitis B (HepB) Patients in Some Previous Entecavir (ETV) Trials
The purpose of this study is to follow patients treated in entecavir Phase III and rollover studies for safety experience and Hepatitis B virus (HBV)-related complications.
- Trial name
- NCT01337479
- Volunteers
- 1,097 people
- Sponsor
- Bristol-Myers Squibb
Kidney Insufficiency, Secondary Hyperparathyroidism
Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice
The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice.
- Trial name
- TOP (NCT01083849)
- Where
- 87 sites in Austria, Germany
- Volunteers
- 761 people
- Sponsor
- AbbVie (prior sponsor, Abbott)