Clinical trials: Open Label
Venous Thromboembolism, Secondary Prevention
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients.
- Trial name
- NCT02197416
- Testing
- dabigatran etexilate
- Where
- 62 sites in United States, Austria and 20 more
- Volunteers
- 214 people
- Sponsor
- Boehringer Ingelheim
Epilepsy, Partial Seizures, Epilepsy, Primary Generalized Tonic-Clonic Seizures
A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures
Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult…
- Trial name
- NCT01463306
- Testing
- Pregabalin
- Where
- 151 sites in United States, Belarus and 29 more
- Volunteers
- 605 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Mucopolysaccharidosis III
Open-label Study of Anakinra in MPS III
Sanfilippo syndrome, or mucopolysaccharidosis type III (MPS III), is a disorder of metabolism, associated with insufficient production of a lysosomal enzyme needed for normal cell function.
- Trial name
- NCT04018755
- Testing
- anakinra
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Lynda E Polgreen
Depression
iTBS for Adolescent Depression: An Open Label Study Evaluating Safety and Efficacy of Treatment
This is an open label, pilot, feasibility study evaluating effects of Intermittent Theta Burst Transcranial Magnetic Stimulation (iTBS) on 5 eligible adolescents for the treatment of depression.
- Trial name
- NCT04485455
- Testing
- iTBS Device/Motor Threshold Coil, iTBS Device/Treatment Coil
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of North Carolina, Chapel Hill
Irritable Bowel Syndrome With Constipation (IBS-C)
Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.
- Trial name
- NCT05905926
- Testing
- Tenapanor
- Where
- 27 sites in United States
- Volunteers
- 150 people
- Sponsor
- Ardelyx
Hemoglobinuria, Paroxysmal
Eculizumab Pharmacokinetics/Pharmacodynamics Study in Pediatric/Adolescent Paroxysmal Nocturnal Hemoglobinuria (PNH)
The primary objective of this study was to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) parameter estimates of eculizumab to confirm the dose regimens for pediatric and adolescent participants with PNH.
- Trial name
- NCT00867932
- Testing
- Eculizumab
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
ADHD, Bipolar Disorder
Concerta in the Treatment of ADHD in Youth and Adults With Bipolar Disorder
The objective of this study is to investigate the safety and effectiveness of Concerta in the treatment of children (ages 5 to 17 years old) and adults (ages 18 to 55 years old) with Bipolar I, Bipolar II and Bipolar Spectrum…
- Trial name
- NCT00181987
- Testing
- methylphenidate HCl (Concerta)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Massachusetts General Hospital
Hemophilia A
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NXT007 prophylaxis compared with emicizumab prophylaxis in people age 12 years and older with severe or moderate congenital…
- Trial name
- ZEBRHA 2 (NCT07416604)
- Testing
- NXT007, Emicizumab
- Where
- 63 sites in United States, Argentina and 20 more
- Volunteers
- 360 people
- Sponsor
- Hoffmann-La Roche
Emergency Contraception
A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions
This study is designed to assess whether consumers select and use ella® (ulipristal acetate 30mg), an emergency contraceptive, in a manner consistent with the OTC package directions in an OTC-like setting.
- Trial name
- LIBRella (NCT03208985)
- Testing
- Use Phase (Ulipristal Acetate, 30 mg)
- Where
- 34 sites in United States
- Volunteers
- 1,270 people, healthy volunteers welcome
- Sponsor
- HRA Pharma
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.
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Treatment Use of Generex Oral-lyn™ in Patients With Diabetes
The objective of this Treatment IND protocol is to provide Generex Oral-lyn™ to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for treatment of…
- Trial name
- NCT00948493
- Testing
- Buccal insulin spray
- Sponsor
- Generex Biotechnology Corp.
Asthma
A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate CHF 6001
The purpose of this study is to evaluate the amount of the study drug, CHF6001, in the blood of adolescent patients with asthma in comparison to adult patients with asthma after a single oral dose of the study drug, CHF 6001.
- Trial name
- NCT06900816
- Testing
- CHF 6001
- Where
- Bulgaria
- Volunteers
- 50 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
HIV Infections
Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019
Dolutegravir is a potent integrase strand transfer inhibitor. Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) is a fixed dose combination regimen containing two nucleoside reverse transcriptase inhibitors and dolutegravir.
- Trial name
- NCT03016533
- Testing
- Dolutegravir film-coated tablets, Dolutegravir film-coated dispersible tablets, ABC/DTG/3TC immediate release tablets
- Where
- 17 sites in United States, Botswana and 5 more
- Volunteers
- 100 people
- Sponsor
- ViiV Healthcare
Common Wart, Warts Hand
Cantharidin and Occlusion in Verruca Epithelium
This is a Phase 2, open label study (Study number VP-102-105; referred to as COVE-1 [Cantharidin and Occlusion in Verruca Epithelium]) to evaluate the efficacy, safety and tolerability of VP-102 treatment in subjects with common…
- Conditions
- Common Wart, Warts Hand, Warts, Papillomavirus Infections
- Trial name
- COVE-1 (NCT03487549)
- Testing
- VP-102 Cantharidin topical film forming solution, VP-102 Cantharidin, topical film forming solution
- Where
- 5 sites in United States
- Volunteers
- 56 people
- Sponsor
- Verrica Pharmaceuticals Inc.
Mucopolysaccharidosis II
A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome
This is a multicenter, multiregional, open-label study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme…
- Trial name
- NCT04251026
- Testing
- tividenofusp alfa
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 47 people
- Sponsor
- Denali Therapeutics Inc.
Lynch Syndrome
Diagnosis of Lynch Syndrome Based on Next-generation Sequencing in Patients Meeting Chinese Lynch Syndrome Criteria
The purpose of this study is to find out the proportion of patients diagnosed with Lynch syndrome in colorectal cacner patients meeting Chinese Lynch syndrome criteria.
- Trial name
- NCT03046849
- Testing
- next-generation sequencing
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
HIV Infections
A Study to See If Taking One or Two Extra Drugs Can Lower HIV Levels in Patients Who Have Failed Their Anti-HIV Drug Treatment
The purpose of this study is to see if adding 1 or 2 drugs to the anti-HIV therapy of patients whose HIV levels increased while taking their anti-HIV drugs can lower viral load (amount of HIV in the blood) and keep it low up to…
- Trial name
- NCT00006152
- Testing
- Ritonavir, Abacavir sulfate, Amprenavir
- Where
- 13 sites in United States
- Volunteers
- 42 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hemophilia B
A Safety and Efficacy Study of a Recombinant Factor IX in Patients With Severe Hemophilia B
This study will examine the safety and efficacy of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) for the control and prevention of bleeding episodes in subjects who have previously received factor…
- Trial name
- NCT01361126
- Testing
- Recombinant Coagulation Factor IX Albumin Fusion Protein
- Where
- 2 sites in Bulgaria, Israel
- Volunteers
- 17 people
- Sponsor
- CSL Behring
Hypochondroplasia
An Interventional Study of Infigratinib in Children With Hypochondroplasia
ACCEL2/3 is a Phase 2/3 study. The purpose of the Phase 2 portion of the study (ACCEL2/3) is to evaluate the efficacy and safety of infigratinib in children with hypochondroplasia (HCH) receiving infigratinib at one of two doses…
- Trial name
- HCH (NCT06873035)
- Testing
- infigratinib 0.128 mg/kg/day, infigratinib 0.25 mg/kg/day
- Where
- 24 sites in United States, Australia and 8 more
- Volunteers
- 24 people
- Sponsor
- QED Therapeutics, a BridgeBio company
Hypertension
The Long-term Study to Evaluate the Safety of Eplerenone in the Treatment of Hypertension in Children Aged 6 to 16 Years
To assess the long-term safety and toleration of eplerenone in the children aged 6 to 16 years with high blood pressure. The study will last at least 1 year and about 140 patients will participate.
- Trial name
- NCT00147615
- Testing
- Eplerenone
- Where
- 21 sites in United States, India and 1 more
- Volunteers
- 140 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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