Clinical trials: System Safety
Hepatitis B
A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)
Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem. GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and in CHB participants on stable nucleos(t)ide…
- Trial name
- B-Clear (NCT04449029)
- Testing
- GSK3228836, Nucleos(t)ide therapy
- Where
- 121 sites in United States, Argentina and 20 more
- Volunteers
- 457 people
- Sponsor
- GlaxoSmithKline
Restless Legs Syndrome
Long-term Study Of Ropinirole In Restless Legs Syndrome
This is an initial placebo-controlled study followed by open treatment evaluating the effectiveness and tolerability of ropinirole long-term in patients with moderate to severe Restless Legs Syndrome.
- Trial name
- NCT00329602
- Testing
- Ropinirole
- Where
- 39 sites in Australia, Czechia and 9 more
- Volunteers
- 404 people
- Sponsor
- GlaxoSmithKline
Retinitis Pigmentosa
Transcorneal Electrical Stimulation - Multicenter Safety Study
The purpose of this study is to expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP.
- Trial name
- NCT01835002
- Testing
- Transcorneal electrostimulation
- Where
- 7 sites in Denmark, Germany and 1 more
- Volunteers
- 105 people
- Sponsor
- Okuvision GmbH
Type 2 Diabetes Mellitus (T2DM)
A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM
To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-KHK and to evaluate the safety, tolerability, efficacy, PK and PD of multiple doses of KHK.
- Trial name
- NCT05761301
- Testing
- ALN-KHK
- Where
- 15 sites in United States, Canada
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Peptic Ulcer Bleeding
Study to Evaluate Efficacy and Safety of Wound Dressing Solution Containing EGF in Patients With Peptic Ulcers Bleeding
This is a prospective, single-blinded, randomized study to evaluate the efficacy and safety of CEGP003 in patients with acute peptic ulcers bleeding, compared to endoscopic epinephrine injection therapy.
- Trial name
- CEGP003 (NCT03469167)
- Testing
- CEGP003, Injection Tx
- Volunteers
- 76 people
- Sponsor
- CGBio Inc.
Arthroplasty, Replacement, Knee, Knee Injuries
ALGRX 4975 After Total Knee Replacement
ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of surgery for total replacement of the knee.
- Trial name
- NCT00132392
- Testing
- ALGRX 4975
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- AlgoRx Pharmaceuticals
Gaucher Disease, Type 1
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)
This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had reached therapeutic goals with enzyme replacement therapy (ERT).
- Trial name
- ENCORE (NCT00943111)
- Testing
- Eliglustat tartrate, Imiglucerase
- Where
- 34 sites in United States, Argentina and 10 more
- Volunteers
- 160 people
- Sponsor
- Genzyme, a Sanofi Company
Rheumatoid Arthritis
Safety Profile of Nulojix in Home Infusion Settings
The study is a retrospective cohort study that utilizes medical records from the BiologicTx. Data accrual starts upon initial home infusion nurse visit until the most recent home infusion nurse visit.
- Trial name
- NCT02500498
- Testing
- Nulojix
- Volunteers
- 37 people
- Sponsor
- Bristol-Myers Squibb
Migraine, Head Pain
A Study Comparing the Effectiveness and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus Placebo for the Treatment of Acute Pain From a Migraine Headache
The purpose of this study is to evaluate the effectiveness and safety of tramadol HCl/acetaminophen as a pain medication compared with placebo in the treatment of acute pain from a migraine headache.
- Conditions
- Migraine, Head Pain, Headache
- Trial name
- NCT00297375
- Testing
- tramadol HCl/acetaminophen
- Volunteers
- 375 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
- Conditions
- Pulmonary Fibrosis, Progressive Pulmonary Fibrosis, Pulmonary Fibrosis Secondary to Systemic Sclerosis, Pulmonary Fibrosis, Interstitial Lung Disease
- Trial name
- NCT06329401
- Testing
- AP01
- Where
- 154 sites in United States, Argentina and 12 more
- Volunteers
- 398 people
- Sponsor
- Avalyn Pharma Inc.
Parkinson Disease
Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease
This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease
- Trial name
- NCT02970019
- Testing
- K0706
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Sun Pharma Advanced Research Company Limited
Ulcerative Colitis (UC)
Dose-Evaluation Study of the Efficacy and Safety of TLA Gut™ Leukapheresis Treatment in Patients With Ulcerative Colitis
An open-label, randomised, multi-centre, dose evaluation study of the efficacy and safety of TLA Gut™ leukapheresis treatment in patients with UC.
- Trial name
- NCT04550130
- Testing
- TLA Gut™
- Where
- Sweden
- Volunteers
- 12 people
- Sponsor
- TLA, Targeted Immunotherapies AB
Refractory Metastatic Colorectal Cancer, Solid Tumor
Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers
This Phase Ib/IIa study comprises a Main Study and a Study Extension. The Main Study has been designed according to a 3+3 Dose Escalation/dose Expansion design in refractory pMMR-MSS mCRC patients.
- Conditions
- Refractory Metastatic Colorectal Cancer, Solid Tumor, Metastatic Microsatellite-stable Colorectal Cancer, Mismatch Repair Protein Proficient
- Trial name
- NCT05205330
- Testing
- CR6086, AGEN2034
- Where
- 3 sites in Italy
- Volunteers
- 107 people
- Sponsor
- Rottapharm Biotech
Type 2 Diabetes Mellitus
Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise
Primary Objective: To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c (HbA1c) reduction in Chinese patients with type 2 diabetes (T2D) who have inadequate glycemic control on diet and…
- Trial name
- NCT03760965
- Testing
- sotagliflozin (SAR439954)
- Where
- 29 sites in China
- Volunteers
- 276 people
- Sponsor
- Sanofi
Gaucher Disease, Type 1 Gaucher Disease
A Long-Term Extension Study of AT2101 (Afegostat Tartrate) in Type 1 Gaucher Patients
This study evaluated the long-term safety and efficacy of afegostat tartrate in participants with Gaucher disease who were enrolled in a previous Phase 2 study of afegostat tartrate.
- Conditions
- Gaucher Disease, Type 1 Gaucher Disease, Gaucher Disease, Type 1
- Trial name
- NCT00813865
- Testing
- afegostat tartrate
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 8 people
- Sponsor
- Amicus Therapeutics
Vitrectomy, Macular Pucker
Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel
- Conditions
- Vitrectomy, Macular Pucker, Retinal Edema
- Trial name
- NCT04501367
- Testing
- Dexamethasone Intracanalicular Insert, 0.4 mg, Prednisone acetate 1%
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Kovach Eye Institute
Rheumatoid Arthritis
Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis
Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments.
- Trial name
- NCT03139136
- Testing
- MBS2320
- Where
- 3 sites in Georgia, Moldova and 1 more
- Volunteers
- 121 people
- Sponsor
- Modern Biosciences Ltd
Exocrine Pancreatic Insufficiency
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis.
- Trial name
- NCT02598128
- Testing
- RELiZORB
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- Alcresta Therapeutics, Inc.
Type 2 Diabetes Mellitus, Diabetes
Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of REMD-477 in Subjects With Type 2 Diabetes Mellitus
This is a randomized, placebo-controlled, double-blind, dose escalation study to evaluate safety, tolerability, PK and PD of single and repeated SC doses of REMD-477 in Type 2 diabetic subjects.
- Trial name
- NCT02455011
- Testing
- REMD-477
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- REMD Biotherapeutics, Inc.
Ovarian Cancer, Healthy Volunteers
Safety and Biodistribution of Technetium Tc 99m EC20 in Normal Volunteers and Ovarian Cancer Patients
Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four subjects with known or suspected ovarian…
- Trial name
- NCT01689636
- Testing
- Tc 99m EC20
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Endocyte
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