Clinical trials: Pathologic Processes
Alpha1-Antitrypsin Deficiency
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin Deficiency
The purpose of this study is to evaluate the safety and tolerability of 72 milligrams per kilogram (mg/kg) and 180 mg/kg Alpha-1 15%, administered as a single-dose subcutaneous (SC) infusion and subsequently as weekly SC…
- Trial name
- NCT04722887
- Testing
- Alpha-1 15%, Liquid Alpha1-Proteinase Inhibitor (Human)
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Grifols Therapeutics LLC
Idiopathic Pulmonary Fibrosis (IPF)
Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)
The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic Pulmonary Fibrosis (IPF). The primary objective is to evaluate the safety and tolerability of INS018_055 orally administered for up to 12…
- Trial name
- NCT05938920
- Testing
- INS018_055
- Where
- 22 sites in China
- Volunteers
- 71 people
- Sponsor
- InSilico Medicine Hong Kong Limited
Atrial Fibrillation
Atrial Fibrillation Progression Trial
The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in…
- Trial name
- ATTEST (NCT01570361)
- Testing
- Catheter Ablation, Drug Treatment
- Volunteers
- 255 people
- Sponsor
- Biosense Webster, Inc.
Surgical Wound, Revision Total Knee Arthroplasty
Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty
This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care…
- Conditions
- Surgical Wound, Revision Total Knee Arthroplasty, Wounds and Injuries, Joint Disease
- Trial name
- PROMISES (NCT03274466)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard of Care Dressing
- Where
- 17 sites in United States
- Volunteers
- 294 people
- Sponsor
- KCI USA, Inc
Idiopathic Pulmonary Fibrosis, Fibrosis
A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory pharmacodynamics (PD) of two treatment…
- Conditions
- Idiopathic Pulmonary Fibrosis, Fibrosis, Idiopathic Interstitial Pneumonias, Pathologic Processes
- Trial name
- NCT03142191
- Testing
- CC-90001
- Where
- 112 sites in United States, Australia and 11 more
- Volunteers
- 138 people
- Sponsor
- Celgene
Sjögren Syndrome
A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome
This was an adaptive design phase 2 study to establish safety and efficacy; and to characterize the dose-response of LOU064 in subjects with moderate to severe Sjögren's syndrome.
- Trial name
- LOUiSSe (NCT04035668)
- Testing
- Remibrutinib
- Where
- 26 sites in United States, Australia and 10 more
- Volunteers
- 73 people
- Sponsor
- Novartis Pharmaceuticals
Candidemia, Mycoses
Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by optional oral fluconazole).
- Conditions
- Candidemia, Mycoses, Fungal Infection, Invasive Candidiases
- Trial name
- ReSTORE (NCT03667690)
- Testing
- Rezafungin for Injection, Caspofungin, Fluconazole
- Where
- 132 sites in United States, Argentina and 16 more
- Volunteers
- 199 people
- Sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Asthma
A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma.
The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during the 24-week treatment in patients with uncontrolled, severe…
- Trial name
- ANDHI (NCT03170271)
- Testing
- Benralizumab (Medi-563)
- Where
- 213 sites in United States, Austria and 12 more
- Volunteers
- 660 people
- Sponsor
- AstraZeneca
Scar Prevention
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
- Trial name
- NCT01037413
- Testing
- EXC 001
- Where
- 5 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
Scar Prevention
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty
This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
- Trial name
- NCT01037985
- Testing
- EXC 001
- Where
- 6 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pathologic Processes
Pivotal Study for Validation of Philips Dx (PDx)
The primary objective of this study is to show safety and effectiveness of the PDx for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.
- Trial name
- NCT02529137
- Where
- 4 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Philips Digital & Computational Pathology
Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.
- Trial name
- NCT02130557
- Testing
- Bosutinib, Imatinib
- Where
- 189 sites in United States, Australia and 24 more
- Volunteers
- 536 people
- Sponsor
- Pfizer
Stress Urinary Incontinence
The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study
An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI).
- Trial name
- NCT01272284
- Testing
- Altis® Single Incision Sling System (SIS)
- Where
- 17 sites in United States, Canada
- Volunteers
- 113 people
- Sponsor
- Coloplast A/S
Myelodysplastic Syndromes
Study of Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes (MDS)
The primary purpose of this study is to determine the effectiveness and safety of azacitidine in the treatment of Taiwanese subjects with higher-risk Myelodysplastic Syndrome (MDS).
- Trial name
- NCT01201811
- Testing
- Azacitidine
- Where
- 11 sites in Taiwan
- Volunteers
- 44 people
- Sponsor
- Celgene
Proctitis, Proctosigmoiditis
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who…
- Trial name
- NCT01008410
- Testing
- Budesonide
- Where
- 63 sites in United States
- Volunteers
- 265 people
- Sponsor
- Bausch Health Americas, Inc.
Proctitis, Proctosigmoiditis
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who…
- Trial name
- NCT01008423
- Testing
- Budesonide
- Where
- 62 sites in United States
- Volunteers
- 281 people
- Sponsor
- Bausch Health Americas, Inc.
Proctitis, Proctosigmoiditis
The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis
The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).
- Trial name
- NCT01349673
- Testing
- Budesonide Foam
- Where
- United States
- Volunteers
- 114 people
- Sponsor
- Bausch Health Americas, Inc.
Mucopolysaccharidosis IIIB
Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 in Mucopolysaccharidosis III, Type B (MPS IIIB)
Study to evaluate the safety and tolerability of intravenous (IV) administration of SBC-103 in participants with mucopolysaccharidosis III, type B (MPS IIIB, Sanfilippo B) with evaluable signs or symptoms of developmental delay.
- Trial name
- NCT02324049
- Testing
- SBC-103
- Where
- 4 sites in United States, Spain and 1 more
- Volunteers
- 11 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Cystic Fibrosis
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Homozygous for the F508del-CFTR Mutation
The purpose of this study was to evaluate the safety and efficacy of ivacaftor in participants with cystic fibrosis (CF) who were aged 12 years or older and were homozygous for the F508del-CF transmembrane conductance regulator…
- Trial name
- DISCOVER (NCT00953706)
- Testing
- Ivacaftor
- Where
- 34 sites in United States
- Volunteers
- 140 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation
The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR)…
- Trial name
- STRIVE (NCT00909532)
- Testing
- Ivacaftor
- Where
- 65 sites in United States, Australia and 6 more
- Volunteers
- 167 people
- Sponsor
- Vertex Pharmaceuticals Incorporated