Clinical trials: Safety
Leber Hereditary Optic Neuropathy
Efficacy & Safety Study of Bilateral IVT Injection of GS010 in LHON Subjects Due to the ND4 Mutation for up to 1 Year
The goal of this clinical trial is to assess the efficacy and safety of GS010 gene therapy - (lenadogene nolparvovec) in subjects with LHON due to the G11778A ND4 mitochondrial mutation with a vision loss up to one year.
- Trial name
- REFLECT (NCT03293524)
- Testing
- GS010
- Where
- 13 sites in United States, Belgium and 5 more
- Volunteers
- 98 people
- Sponsor
- GenSight Biologics
COPD
Crossover Study to Assess the Efficacy of PT003 With and Without a Valved Holding Chamber in Subjects With Moderate to Severe COPD
This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to Severe COPD with and without a Valved Holding Chamber.
- Trial name
- NCT02454959
- Testing
- GFF MDI (PT003) with Aerochamber, GFF MDI (PT003) without Aerochamber
- Where
- 6 sites in United States
- Volunteers
- 80 people
- Sponsor
- Pearl Therapeutics, Inc.
Seasonal Influenza
Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age
This study will evaluate the safety and immunogenicity in healthy children and adolescents after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.
- Trial name
- NCT01209780
- Testing
- TIV, TIVf, Comparator TIV
- Where
- 13 sites in Colombia, Mexico and 2 more
- Volunteers
- 3,116 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Non-Alcoholic Steatohepatitis
Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in overweight and obese adults.
- Trial name
- NCT02287779
- Testing
- SHP626
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Mirum Pharmaceuticals, Inc.
Non Hodgkin Lymphoma, Follicular Lymphoma
Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL
This study is a Phase 1b, open-label, single arm dose escalation study of Betalutin followed by rituximab in patients with previously treated follicular lymphoma.
- Conditions
- Non Hodgkin Lymphoma, Follicular Lymphoma, Relapsed Follicular Lymphoma
- Trial name
- LYMRIT-37-07 (NCT03806179)
- Testing
- 10 MBq/kg Betalutin, 15 MBq/kg Betalutin
- Where
- 2 sites in Czechia, Norway
- Volunteers
- 7 people
- Sponsor
- Nordic Nanovector
Waldenstrom's Macroglobulinemia, Non-Hodgkin's Lymphoma
Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies
The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's…
- Conditions
- Waldenstrom's Macroglobulinemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma
- Trial name
- NCT00150462
- Testing
- Carfilzomib, Dexamethasone
- Where
- 5 sites in United States
- Volunteers
- 48 people
- Sponsor
- Amgen
Short Stature Children Born Small for Gestational Age (SGA)
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already…
- Trial name
- NCT03878446
- Testing
- Somapacitan, Norditropin®
- Where
- 95 sites in United States, Algeria and 21 more
- Volunteers
- 62 people
- Sponsor
- Novo Nordisk A/S
Hemophilia B
Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients
The purpose of this pivotal Phase 1/3 study is to determine the pharmacokinetic (PK) parameters, the hemostatic efficacy, and the safety of BAX 326, a recombinant factor IX, in previously treated patients (PTPs) with severe and…
- Trial name
- NCT01174446
- Testing
- BAX 326, BeneFIX
- Where
- 25 sites in Argentina, Brazil and 12 more
- Volunteers
- 86 people
- Sponsor
- Baxalta now part of Shire
Pulmonary Arterial Hypertension
Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide
This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during right heart catheterization (RHC) in participants with pulmonary arterial…
- Trial name
- PILOT (NCT01092559)
- Testing
- Nitric Oxide generated by the GeNO nitrosyl delivery system
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Geno LLC
Pulmonary TB
A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis
This trial will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of multiple oral doses of OPC-167832 in participants with uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis (TB).
- Trial name
- NCT03678688
- Testing
- 10 mg OPC-167832, 30 mg OPC-167832, 90 mg OPC-167832
- Where
- 3 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Rheumatoid Arthritis
Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy
This observational study will evaluate the safety, tolerability and efficacy of tocilizumab in participants with moderate to severe RA who have an inadequate response to current non-biologic DMARD and/or anti-TNF therapy.
- Trial name
- NCT01362062
- Testing
- Tocilizumab
- Where
- 7 sites in India
- Volunteers
- 110 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus, Type 2
A Study to Test How Well Empagliflozin Works in Japanese People With Type 2 Diabetes Who Are Older Than 65 Years
This study is to assess the efficacy of empagliflozin 10 mg after 52 weeks compared to placebo in elderly patients with Type 2 diabetes mellitus (T2DM) and to explore if empagliflozin has any impact on patient physical condition…
- Trial name
- NCT04531462
- Testing
- Empagliflozin
- Where
- 18 sites in Japan
- Volunteers
- 129 people
- Sponsor
- Boehringer Ingelheim
Pulmonary Disease, Chronic Obstructive
Tiotropium / Respimat One Year Study in COPD.
The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD.
- Trial name
- NCT00387088
- Testing
- Respimat, Tiotropium
- Where
- 334 sites in United States, Australia and 29 more
- Volunteers
- 3,991 people
- Sponsor
- Boehringer Ingelheim
Tumor, Pain
A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine
The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
- Trial name
- NCT00472303
- Testing
- Tapentadol Extended Release, Morphine Sulphate Controlled Release
- Where
- 71 sites in Austria, Bulgaria and 14 more
- Volunteers
- 622 people
- Sponsor
- Grünenthal GmbH
Hemophagocytic Lymphohistiocytoses
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH
Hemophagocytic lymphohistiocytosis (HLH) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of several clinical conditions (e.g.
- Trial name
- NCT03985423
- Testing
- Emapalumab-Lzsg
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Swedish Orphan Biovitrum
Cataract, Inflammation
Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
- Conditions
- Cataract, Inflammation, Surgery
- Trial name
- NCT01591161
- Testing
- Mapracorat
- Where
- United States
- Volunteers
- 369 people
- Sponsor
- Bausch & Lomb Incorporated
Infection, Human Immunodeficiency Virus I
48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection
This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection .
- Trial name
- NCT00089583
- Testing
- LEXIVA (GW433908), Ritonavir
- Where
- 39 sites in United States, Belgium and 5 more
- Volunteers
- 110 people
- Sponsor
- ViiV Healthcare
Respiratory Syncytial Virus
Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017)
This is a study of molnupiravir (MK-4482) in healthy participants who have been inoculated with an experimental Respiratory Syncytial Virus (RSV) [RSV-A Memphis 37b].
- Trial name
- NCT05559905
- Testing
- Molnupiravir, RSV A Memphis 37b
- Where
- United Kingdom
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Respiratory Distress Syndrome, Newborn
A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory…
- Trial name
- NCT04264156
- Testing
- Lucinactant for Inhalation, nCPAP Only
- Where
- 3 sites in Poland
- Volunteers
- 12 people
- Sponsor
- Windtree Therapeutics
Multiple Sclerosis (MS)
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with relapsing Multiple Sclerosis (RMS).
- Trial name
- NCT03737851
- Testing
- elezanumab
- Where
- 49 sites in United States, Canada
- Volunteers
- 208 people
- Sponsor
- AbbVie