Clinical trials: Multicenter Prospective Study
Primary Immunodeficiency Disease
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
- Trial name
- NCT02810444
- Testing
- IgG Next Generation (BT595)
- Where
- 19 sites in United States, Germany and 3 more
- Volunteers
- 81 people
- Sponsor
- Biotest
Hypovolemia
Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients
This is a randomized, controlled, open-label clinical trial aimed to evaluate the Safety of Kedbumin 25% Compared to Normal Saline Solution in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients Undergoing Major…
- Trial name
- NCT01531803
- Testing
- Kedbumin 25%, Normal Saline Solution
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Kedrion S.p.A.
Post Menopausal Osteoporosis
A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment.
- Trial name
- NCT02598934
- Testing
- Ibandronate
- Where
- 53 sites in United States, Puerto Rico
- Volunteers
- 308 people
- Sponsor
- Hoffmann-La Roche
Hypothyroidism
Thyroid Function of Pediatric Subjects Following Isovue® Administration
This is a Phase IV prospective, multicenter, observational study to estimate the proportion of subjects 0 to 3 years of age who develop abnormal thyroid function after exposure to intravascular administration of ISOVUE for the…
- Trial name
- NCT03779906
- Testing
- Isovue
- Where
- 4 sites in United States
- Volunteers
- 17 people
- Sponsor
- Bracco Diagnostics, Inc
Cystic Fibrosis
A Two-Part Multicenter Prospective Longitudinal Study of CFTR-dependent Disease Profiling in Cystic Fibrosis (PROSPECT)
identify and validate biomarkers that might reflect partial restoration of CFTR function and can be used to monitor disease progression, and ii) evaluate the mechanistic effects of CFTR modulators and other relevant therapies in…
- Trial name
- PROSPECT (NCT02477319)
- Testing
- Observational
- Where
- 38 sites in United States
- Volunteers
- 452 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Atypical Hemolytic Uremic
Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China
This is a Phase 3b, open-label, single-arm, multicenter study to evaluate the efficacy and safety of eculizumab in participants with atypical hemolytic uremic syndrome (aHUS) in China
- Trial name
- Soliris (NCT05876351)
- Testing
- Eculizumab
- Where
- 6 sites in China
- Volunteers
- 25 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hemophilia B
BAX 326 Pediatric Study
The purpose of this study is to assess BAX 326 pharmacokinetic parameters, to evaluate its hemostatic efficacy, safety, immunogenicity, and changes in health-related quality of life in pediatric patients.
- Trial name
- NCT01488994
- Testing
- BAX326
- Where
- 11 sites in India, Poland and 4 more
- Volunteers
- 23 people
- Sponsor
- Baxalta now part of Shire
Lower Limb Spasticity Due to Cerebral Palsy
Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle…
- Trial name
- NCT01893411
- Testing
- IncobotulinumtoxinA (16 Units per kg body weight), IncobotulinumtoxinA (12 Units per kg body weight), IncobotulinumtoxinA (4 Units per kg body weight)
- Where
- 53 sites in Austria, Czechia and 12 more
- Volunteers
- 311 people
- Sponsor
- Merz Pharmaceuticals GmbH
Pulmonary Arterial Hypertension
Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension
The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) <12 years of age.
- Trial name
- FUTURE 3 (NCT01223352)
- Testing
- bosentan
- Volunteers
- 64 people
- Sponsor
- Actelion
Intraoperative Ureter Visualization, Abdominolpelvic Surgery
A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery
The ureter was the tube that carries urine from the kidneys to the bladder. It was difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious.
- Trial name
- NCT05754333
- Testing
- pudexacianinium chloride
- Where
- 6 sites in United States
- Volunteers
- 107 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Pneumonia, Bacterial, Community-Acquired Infections
A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia
The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with pneumonia.
- Conditions
- Pneumonia, Bacterial, Community-Acquired Infections, Nosocomial Infection, Pneumonia, Ventilator-Associated
- Trial name
- NCT01110421
- Testing
- Cefepime, Doripenem, Amoxicillin/clavulanate potassium
- Where
- 25 sites in United States, Argentina and 8 more
- Volunteers
- 7 people
- Sponsor
- Janssen Research & Development, LLC
Aortic Valve Stenosis
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for…
- Trial name
- NCT03517436
- Testing
- TAVR with CENTERA THV
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Edwards Lifesciences
Primary Immunodeficiency Disease
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients
The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).
- Trial name
- CARES10 (NCT03961009)
- Testing
- Kedrion IVIG 10%
- Where
- 11 sites in United States
- Volunteers
- 47 people
- Sponsor
- Kedrion S.p.A.
Factor XIII Deficiency
A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
Congenital deficiency of factor XIII (FXIII) is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII.
- Trial name
- NCT00885742
- Testing
- FXIII Concentrate (Human)
- Where
- 23 sites in United States, Spain
- Volunteers
- 41 people
- Sponsor
- CSL Behring
Relapsing Multiple Sclerosis (RMS)
Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients
The main purpose of this study was to assess the efficacy and safety of 0.5mg Fingolimod (Gilenya) in Chinese patients with relapsing multiple sclerosis (RMS)
- Trial name
- NCT04667949
- Testing
- Fingolimod 0.5mg
- Where
- 13 sites in China
- Volunteers
- 98 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Arterial Hypertension
FUTURE 3 Study Extension
The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension…
- Trial name
- FUTURE 3 Ext (NCT01338415)
- Testing
- Bosentan
- Where
- 36 sites in United States, Australia and 16 more
- Volunteers
- 58 people
- Sponsor
- Actelion
Chronic Troublesome Sialorrhea, Cerebral Palsy
Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability
The objective of this study is to investigate the efficacy and safety of NT 201 compared with placebo for the treatment of chronic troublesome sialorrhea associated with neurological disorders (e.g.
- Conditions
- Chronic Troublesome Sialorrhea, Cerebral Palsy, Stroke, Traumatic Brain Injury
- Trial name
- SIPEXI (NCT02270736)
- Testing
- NT 201
- Where
- 31 sites in Georgia, Hungary and 4 more
- Volunteers
- 256 people
- Sponsor
- Merz Pharmaceuticals GmbH
Traumatic Injury
Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have…
- Trial name
- NCT05568888
- Testing
- BE1116
- Where
- 113 sites in United States, Australia and 1 more
- Volunteers
- 1,366 people
- Sponsor
- CSL Behring
HIV, Pediatric
Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients
The purpose of this study is to collect safety clinical data in HIV-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and…
- Trial name
- NCT01691794
- Testing
- Atazanavir, Ritonavir
- Where
- 27 sites in United States, Argentina and 6 more
- Volunteers
- 108 people
- Sponsor
- Bristol-Myers Squibb
Hemophilia A
A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A
The main aim of the study is to determine how well Adynovate works to decrease bleeding in previously treated Chinese men and boys with severe hemophilia A when given prophylactically.
- Trial name
- NCT05707351
- Testing
- Adynovate
- Where
- 12 sites in China
- Volunteers
- 37 people
- Sponsor
- Takeda