Clinical trials: Open Label
Infection, Neutropenia
Daptomycin or Vancomycin in Treating Bacteria in the Blood in Patients With Neutropenia Caused By Chemotherapy
RATIONALE: Antibiotics, such as daptomycin and vancomycin, may be effective in treating bacteria in the blood. It is not yet known whether daptomycin is more effective than vancomycin in treating bacteria in the blood in patients…
- Conditions
- Infection, Neutropenia, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Trial name
- NCT00296049
- Testing
- daptomycin, vancomycin
- Where
- United States
- Sponsor
- Wake Forest University Health Sciences
Bipolar Disorder
Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders
Children between the ages of 5-17 years old who have or display symptoms of emotional dysregulation (explosiveness, mood swings, irritability, and/or violent behavior) are invited to participate in a 12-week research study to…
- Trial name
- NCT02357290
- Testing
- Open-label Treatment with N-Acetylcysteine
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Massachusetts General Hospital
Prader-Willi Syndrome
An Open-Label Study of DCCR Tablet in Patients With PWS
The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.
- Trial name
- NCT04086810
- Testing
- DCCR
- Sponsor
- Soleno Therapeutics, Inc.
Epilepsy
The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy
To evaluate the efficacy of usual monotherapy and low dose combination of Lamotrigine and Valproate. Low dose combination may be more effective and tolerable because they are low dose and VPA reduce Lamotrigine metabolism.
- Trial name
- NCT00807989
- Testing
- Carbamazepine, Lamotrigine/Valproate
- Where
- South Korea
- Volunteers
- 207 people
- Sponsor
- Yonsei University
Meningococcal Vaccine
Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age
This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age.
- Trial name
- NCT04819113
- Testing
- Nimenrix
- Where
- 16 sites in Finland, Poland and 1 more
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Pfizer
Graft Versus Host Disease
T&B Depletion Non Malignant
The primary aim of the present trial is to assess in a randomized fashion the benefit on standard graft-versus-host disease (GVHD) prophylaxis of the addition of ATG-Fresenius S ® in transplants from matched related donors (MRD)…
- Trial name
- NCT01810926
- Testing
- polyclonal antibody, Rituximab, Treosulfan
- Where
- 4 sites in Italy
- Volunteers
- 130 people
- Sponsor
- Franco Locatelli
Schizophrenia, Bipolar I Disorder
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1)
This study is an open label, sequential-group, two site, multiple dose escalating study of sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I disorder; in one study cohort (3a)…
- Trial name
- NCT01206517
- Testing
- Asenapine 2.5 mg, Asenapine 5 mg, Asenapine 10 mg
- Volunteers
- 30 people
- Sponsor
- Organon and Co
Ulcerative Colitis, Ulcerative Colitis Chronic
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD).
- Conditions
- Ulcerative Colitis, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases, Crohn's Disease
- Trial name
- SHINE-ON (NCT04844606)
- Testing
- Mirikizumab
- Where
- 69 sites in United States, Austria and 14 more
- Volunteers
- 150 people
- Sponsor
- Eli Lilly and Company
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Open-Label Phase III Long-Term Safety Trial of Liprotamase
This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in patients with cystic fibrosis (CF)-related exocrine pancreatic insufficiency (PI).
- Trial name
- DIGEST (NCT00449904)
- Testing
- Liprotamase
- Where
- 39 sites in United States
- Volunteers
- 214 people
- Sponsor
- Anthera Pharmaceuticals
Severe Hemophilia A
Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale
The primary objective of the study is to compare the pharmacokinetic (PK) of recombinant coagulation factor VIII Fc fusion protein (rFVIIIFc) manufactured at the current scale of 2000 L (2K) to the PK of rFVIIIFc manufactured at…
- Trial name
- Elevate (NCT02502149)
- Testing
- rFVIIIFc
- Where
- 15 sites in United States, Australia and 1 more
- Volunteers
- 24 people
- Sponsor
- Bioverativ Therapeutics Inc.
Gonorrhea
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
This is a phase III, randomized, multicenter, open-label study which will be performed to evaluate efficacy and safety of oral Gepotidacin compared to intramuscular (IM) ceftriaxone plus oral azithromycin for the treatment of…
- Trial name
- NCT04010539
- Testing
- Gepotidacin, Ceftriaxone, Azithromycin
- Where
- 51 sites in United States, Australia and 4 more
- Volunteers
- 628 people
- Sponsor
- GlaxoSmithKline
Severe Hemophilia A
Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A
The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of…
- Trial name
- NCT01181128
- Testing
- Factor VIII (rFVIIIFc), Advate®
- Where
- 64 sites in United States, Australia and 17 more
- Volunteers
- 165 people
- Sponsor
- Bioverativ Therapeutics Inc.
Colitis, Ulcerative
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)
The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with…
- Trial name
- UNIFI Jr (NCT04630028)
- Testing
- Ustekinumab Dose Based on BSA and Body Weight
- Where
- 58 sites in United States, Belgium and 7 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Phenylketonuria
Long-Term Extension of Previous rAvPAL-PEG Protocols in Subjects With PKU (PAL-003)
This study is an extension of previous rAvPAL-PEG studies. Administration of rAvPAL-PEG will be continued to assess whether long-term dosing of rAvPAL-PEG is safe and can maintain reduced blood Phe concentrations in PKU subjects.
- Trial name
- NCT00924703
- Testing
- rAvPAL-PEG
- Where
- 14 sites in United States
- Volunteers
- 68 people
- Sponsor
- BioMarin Pharmaceutical
Human African Trypanosomiasis (HAT), Sleeping Sickness
Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2
This clinical trial is designed to prove the efficacy and safety of Fexinidazole as an oral treatment for human african trypanosomiasis in advanced stage. The Fexinidazole is compared to reference treatment NECT.
- Trial name
- NCT01685827
- Testing
- Fexinidazole, Nifurtimox, Eflornithine
- Where
- 10 sites in Central African Republic, Democratic Republic of the Congo and 1 more
- Volunteers
- 394 people
- Sponsor
- Drugs for Neglected Diseases
Primary Immunodeficiency
Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency
Approximately 60 subjects will be enrolled in order to have approximately 20 adult subjects and 20 pediatric subjects treated with subcutaneously administered Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography…
- Trial name
- NCT02806986
- Testing
- IGSC 20%
- Where
- 23 sites in Australia, Czechia and 7 more
- Volunteers
- 61 people
- Sponsor
- Grifols Therapeutics LLC
Gaucher Disease, Type 3
High-Dose Ambroxol in Pediatric Type III Gaucher Disease (GD3)
Type: Prospective, open-label, single center study Duration: 6 months with an optional 12-month extension phase Participants: 12 pediatric patients diagnosed with type III Gaucher disease (GD3) aged ≥3 to ≤18 years old treatment…
- Trial name
- NCT07285369
- Testing
- Ambroxol
- Where
- Pakistan
- Volunteers
- 12 people
- Sponsor
- Agyany Pharma LTD
Asthma
Atlantis Symbicort
The purpose of this study is to determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.
- Trial name
- NCT00646594
- Testing
- budesonide/formoterol (Symbicort), fluticasone/salmeterol (Advair)
- Volunteers
- 1,200 people
- Sponsor
- AstraZeneca
Diabetes Mellitus, Type 2
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients according to the prescribing information
- Trial name
- AVANDAMETPMS (NCT01294553)
- Testing
- Administration of rosiglitazone/metformin
- Volunteers
- 717 people
- Sponsor
- GlaxoSmithKline
Neisseria Meningitidis
NeisVac-C Single Prime Study in Infants
The purpose of this study is to assess the feasibility of a single priming dose of NeisVac-C in infants (at either 4 or 6 months of age), as determined by immune response.
- Trial name
- NCT01218451
- Testing
- Meningococcal group C polysaccharide conjugate vaccine, Pneumococcal 13-valent conjugate vaccine, Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine
- Where
- 24 sites in Poland, Spain
- Volunteers
- 956 people, healthy volunteers welcome
- Sponsor
- Pfizer
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