Clinical trials: Patient Safety
Hereditary Hemochromatosis
Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis (HH)
The purpose of this study was to evaluate the efficacy and safety of deferasirox film coated tablet (FCT) versus phlebotomy for the management of iron overload in adults with Hereditary Hemochromatosis (HH) at risk of…
- Trial name
- NCT03203850
- Testing
- Deferasirox FCT, Phlebotomy
- Where
- 11 sites in Belgium, France and 5 more
- Volunteers
- 45 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Tuberculosis
Early Bactericidal Activity of TBA-7371 in Pulmonary Tuberculosis
The purpose of this study is to assess the safety, early bactericidal activity (EBA) and pharmacokinetics of TBA-7371 in adult participants with rifampicin-sensitive tuberculosis and select dose regimen(s) for future studies.
- Trial name
- NCT04176250
- Testing
- TBA-7371, HRZE
- Where
- 4 sites in South Africa
- Volunteers
- 93 people
- Sponsor
- Gates Medical Research Institute
Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection, COVID-19
A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection
This is a Phase 2, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken once daily at bedtime for the management…
- Conditions
- Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection, COVID-19, Long COVID, Long Haul COVID
- Trial name
- PREVAIL (NCT05472090)
- Testing
- TNX-102 SL
- Where
- 29 sites in United States
- Volunteers
- 63 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
Proliferative Diabetic Retinopathy
Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
The purpose of this study was to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR).
- Trial name
- CONDOR (NCT04278417)
- Testing
- Brolucizumab 6 mg, Panretinal photocoagulation laser
- Where
- 120 sites in United States, Argentina and 14 more
- Volunteers
- 689 people
- Sponsor
- Novartis Pharmaceuticals
Diabetic Retinopathy
Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
This Phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the treatment of diabetic retinopathy. To assess efficacy, the retinal morphology will be investigated by 7-field color fundus photography…
- Trial name
- NEON-NPDR (NCT04722991)
- Testing
- Runcaciguat (BAY1101042)
- Where
- 55 sites in United States, Bulgaria and 12 more
- Volunteers
- 109 people
- Sponsor
- Bayer
Antithrombin III Deficiency
Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures.
- Trial name
- NCT00110513
- Testing
- Recombinant human antithrombin (rhAT)
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 18 people
- Sponsor
- rEVO Biologics
Atrial Fibrillation
A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)
This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm compared to placebo.
- Trial name
- NCT01174160
- Testing
- vernakalant hydrochloride
- Volunteers
- 123 people
- Sponsor
- Advanz Pharma
Hyperlipidemias
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy
The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol…
- Trial name
- NCT03337308
- Testing
- Bempedoic Acid + Ezetimibe Fixed-Dose Combination, Bempedoic Acid, Ezetimibe
- Where
- 5 sites in United States
- Volunteers
- 382 people
- Sponsor
- Esperion Therapeutics, Inc.
Haemophilia B
A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B
The study investigates how well the medicine called nonacog beta pegol (N9-GP) works in Chinese people with haemophilia B. Participants will be treated with N9-GP.
- Trial name
- Paradigm9 (NCT05365217)
- Testing
- Nonacog beta pegol
- Where
- 15 sites in China
- Volunteers
- 30 people
- Sponsor
- Novo Nordisk A/S
Mantle Cell Lymphoma
A Phase II Study to Evaluate Efficacy and Safety of P276-00 in Relapsed and/or Refractory Mantle Cell Lymphoma
The purpose of this study is to determine whether P276-00 is safe and effective in treatment of Mantle Cell Lymphoma that is recurred after or not responding to at least one previous line of treatment.
- Trial name
- NCT00843050
- Testing
- P276-00
- Where
- 20 sites in United States, India
- Volunteers
- 13 people
- Sponsor
- Piramal Enterprises Limited
Cancer Cachexia
Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia
The purpose of this study is to evaluate the safety and efficacy of repeated oral administration of macimorelin at different doses daily for 1 week for the treatment of cancer cachexia.
- Trial name
- NCT01614990
- Testing
- Macimorelin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Garcia, Jose M., MD, PhD
Schizophrenia, Schizophreniform Disorder
An Efficacy and Safety Study of Risperidone Long-Acting Microspheres in Participants With Schizophrenia, Schizophreniform or Schizoaffective Disorders
The purpose of this study is to evaluate the efficacy and safety of long acting injectable microspheres of risperidone in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment…
- Conditions
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
- Trial name
- NCT01855074
- Testing
- Risperidone
- Volunteers
- 80 people
- Sponsor
- Janssen-Cilag Ltd.
HIV-1-infection
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE
This study will evaluate the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV-1 infected patients who actively use illicit substances.
- Trial name
- BASE (NCT03998176)
- Testing
- Bictegravir/emtricitabine/tenofovir alafenamide
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- University of Nebraska
Dry Eye Syndromes
Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery
The purpose of this study is determine whether 3% diquafosol and 0.1% sodium hyaluronate are effective and safe in the treatment of patients with dry eye after cataract surgery.
- Trial name
- NCT02608489
- Testing
- Diquafosol (Diquas), Sodium Hyaluronate (Hyalein)
- Volunteers
- 86 people
- Sponsor
- Soonchunhyang University Hospital
Spasticity Due to Cerebral Palsy
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects 2 to 16 Years Old With Mild…
- Trial name
- NCT01405950
- Testing
- Zanaflex Capsules
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Acorda Therapeutics
Chronic Graft-versus-host-disease
A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)
This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received…
- Trial name
- AGAVE-201 (NCT04710576)
- Testing
- Axatilimab
- Where
- 121 sites in United States, Australia and 14 more
- Volunteers
- 296 people
- Sponsor
- Syndax Pharmaceuticals
Major Depressive Disorder
Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder
The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD).
- Trial name
- NCT01447576
- Testing
- ADT, OPC-34712
- Where
- 32 sites in United States
- Volunteers
- 1,036 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Functional Dyspepsia
The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia
The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to placebo in Japanese subjects with Functional Dyspepsia (FD).
- Trial name
- NCT02037776
- Testing
- Rikkunshito
- Where
- Japan
- Volunteers
- 128 people
- Sponsor
- Osaka City University
Cushings Disease
Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease
The study aimed to confirm long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease. It was a pivotal trial which supported the registration of LCI699 for the treatment of patients with…
- Trial name
- NCT02180217
- Testing
- osilodrostat
- Where
- 60 sites in United States, Argentina and 17 more
- Volunteers
- 137 people
- Sponsor
- Novartis Pharmaceuticals
Endothelial Dysfunction, Metabolic Syndrome
Infusion of Umbilical Cord Versus Bone Marrow Derived Mesenchymal Stem Cells to Evaluate Cytokine Suppression.
This study is to compare the safety and efficacy of UCMSCs and BMMSCs administered intravenously in patients to evaluate cytokine suppression in patients with chronic inflammation.
- Conditions
- Endothelial Dysfunction, Metabolic Syndrome, Chronic Inflammation
- Trial name
- CERES (NCT03059355)
- Testing
- UCMSCs, BMMSCs
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Joshua M Hare
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