Clinical trials: Delivery Systems
Duchenne Muscular Dystrophy
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
The study will evaluate the safety and efficacy of gene transfer therapy in boys with DMD. It is a randomized, double-blind, placebo-controlled study.
- Trial name
- EMBARK (NCT05096221)
- Testing
- delandistrogene moxeparvovec
- Where
- 42 sites in United States, Belgium and 7 more
- Volunteers
- 126 people
- Sponsor
- Sarepta Therapeutics, Inc.
Hepatitis C, Chronic
Directly Observed Therapy for HCV in Chennai, India
The primary objective of this pilot trial is to evaluate the feasibility of 12 weeks vs. 24 weeks of field-based directly observed therapy (DOT) for HCV therapy in a resource-limited setting.
- Trial name
- C-DOT (NCT02541409)
- Testing
- Sofosbuvir, Pegylated Interferon alfa-2a, Ribavirin
- Where
- India
- Volunteers
- 50 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Hantavirus Pulmonary Infection, Immunisation
Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis(R) Needle-Free Injection Delivery Device
This is a Phase 1, randomized, placebo controlled, double-blind, dose escalation trial of 48 males and non-pregnant females, 18-49 years old, inclusive, who are in good health and meet all eligibility criteria.
- Trial name
- NCT03682107
- Testing
- Andes virus DNA vaccine
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Stress Disorders, Posttraumatic, Depression
Re-Engineering Systems for the Primary Care Treatment for PTSD
The study is an evaluation of a systemic intervention to enhance the delivery of care according to practice guidelines for posttraumatic stress disorder (PTSD).
- Trial name
- RESPECT-PTSD (NCT00373698)
- Testing
- Three Component Model of Collaborative Care
- Where
- 4 sites in United States
- Volunteers
- 195 people
- Sponsor
- US Department of Veterans Affairs
Healthy Volunteer
Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge
Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrhea worldwide. Vaccines and therapeutics are under development to prevent ETEC disease in children and travelers.
- Trial name
- NCT03040687
- Testing
- Anti CS6 BSIgG product (Lot PD1601105CS), Anti B7A BSIgG product (Lot PD1601132ET), Bovine Immunoglobin Negative Control (Lot PD161071NC)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Smoking
Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L
The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, and the safety and tolerability of the nicotine-containing aerosol delivered by Platform 3 Liquid…
- Trial name
- NCT02532374
- Testing
- Nicorette® inhalator, P3L
- Where
- New Zealand
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Type 2 Diabetes, Homeless Persons
Diabetes Homeless Medication Support Single Arm Treatment Development Trial
This single-arm trial of the Diabetes Homeless Medication Support intervention alone (n=15) will test the perception and feasibility of anticipated study procedures.
- Trial name
- D-Homes (NCT04678284)
- Testing
- Diabetes Homeless Medication Support (D-Homes)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Hennepin Healthcare Research Institute
Obesity
The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity
The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System compared to a sham control for the treatment obesity.
- Trial name
- ReCharge (NCT01327976)
- Testing
- vBloc (Active Device)
- Where
- 10 sites in United States, Australia
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- ReShape Lifesciences
Feeding; Difficult, Newborn, Growth Failure
Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections.
- Conditions
- Feeding; Difficult, Newborn, Growth Failure, Necrotizing Enterocolitis, Sepsis
- Trial name
- PROPEL (NCT01603368)
- Testing
- Lactobacillus reuteri
- Where
- 2 sites in Sweden
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Ostergotland County Council, Sweden
Cardiovascular Diseases, Diabetes
Diabetes Remote Intervention to improVe Use of Evidence-based Medications
A randomized remote, implementation trial in the Mass General Brigham network was performed on 200 patients with T2D at high CV or kidney risk.
- Trial name
- DRIVE (NCT06046560)
- Testing
- SGLT2 inhibitor, GLP-1 RA, Education-First
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Spinal Muscular Atrophy
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy (SMA)
The primary objective is to examine the clinical efficacy of multiple doses of nusinersen (ISIS 396443) administered intrathecally to participants with Infantile-Onset Spinal Muscular Atrophy (SMA).
- Trial name
- NCT01839656
- Testing
- nusinersen
- Where
- 4 sites in United States, Canada
- Volunteers
- 21 people
- Sponsor
- Biogen
Asthma
To Compare the Pharmacokinetics of Budesonide Delivered by BDA MDI to Budesonide Delivered by Pulmicort Respules in Children With Asthma Aged 4 to 8 Years.
To compare the pharmacokinetics of budesonide delivered by BDA MDI to budesonide delivered by Pulmicort Respules in children with Asthma aged 4 to 8 years.
- Trial name
- BLANC (NCT04848662)
- Testing
- BDA MDI (PT027) 160/180 μg, Pulmicort Respules 0.5 MG/ML Inhalation Suspension
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Bond Avillion 2 Development LP
Anal Neoplasm
VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL) in Individuals Seronegative for Human Immunodeficiency Virus (HIV)-1/2
This is a phase 2, open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are human immunodeficiency virus (HIV) negative with histologically…
- Trial name
- NCT03499795
- Testing
- VGX-3100, CELLECTRA™ 5PSP
- Where
- 3 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Inovio Pharmaceuticals
Coronary Artery Disease
NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary…
- Trial name
- NCT00231283
- Testing
- CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Cordis US Corp.
Prematurity, Anemia
Transfusions and Nitric Oxide Level in Preterm Infants
The purpose of this study is to better understand S-nitrosohemeglobin (SNO-Hb) in transfused blood of extremely preterm infants.
- Conditions
- Prematurity, Anemia, Necrotizing Enterocolitis
- Trial name
- NCT00787124
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Duke University
Multiple Sclerosis
Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue
This clinical trial will compare the effectiveness of 3 treatments for fatigue in Multiple Sclerosis: 1) a commonly used behavioral treatment strategy (telephone-based cognitive behavioral therapy), 2) a commonly used medication…
- Trial name
- COMBO-MS (NCT03621761)
- Testing
- Telephone-based Cognitive Behavioral Therapy, Modafinil
- Where
- 2 sites in United States
- Volunteers
- 343 people
- Sponsor
- University of Michigan
Pain, Postoperative
Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery
This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative pain after scheduled, elective Cesarean delivery.
- Trial name
- NCT02487303
- Testing
- Acetaminophen Intravenous, Acetaminophen Oral
- Where
- United States
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Any Solid Malignancies of Any Tissue Origin (Except for Small Cell Lung Cancer) Involving the Upper Abdomen and Thorax
Novel Optical Surface Image Guidance System for Beam-Gated Online Adaptive SBRT Delivery in Mobile Lower Lung and Upper Abdominal Malignancies
Motion during radiation therapy can be categorized as inter-fraction (changes in anatomy that occur between treatment days) and intra-fraction (changes that occur during the "beam on" window of treatment delivery).
- Trial name
- NCT05030454
- Testing
- ETHOS, CT-guided stereotactic adaptive radiotherapy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Washington University School of Medicine
Asthma
An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma
This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate…
- Trial name
- NCT01706198
- Testing
- fluticasone furoate + vilanterol, inhaled corticosteroid with or without a long acting beta2-agonist
- Where
- 180 sites in United Kingdom
- Volunteers
- 4,233 people
- Sponsor
- GlaxoSmithKline
Healthy
Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System
Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.
- Trial name
- NCT02158572
- Testing
- AG200-15
- Volunteers
- 2,032 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics