Clinical trials: System Safety
Phenylketonuria
Kuvan® in Phenylketonuria Patients Less Than 4 Years Old
This is a Phase 3b, multicenter, open-label, randomized, controlled study to evaluate efficacy, safety and population pharmacokinetics of sapropterin dihydrochloride (Kuvan®) in less than 4 year-old infants and children with…
- Trial name
- SPARK (NCT01376908)
- Testing
- Kuvan®, Phenylalanine (Phe)-restricted diet
- Where
- 22 sites in Austria, Belgium and 7 more
- Volunteers
- 56 people
- Sponsor
- BioMarin Pharmaceutical
IgA Nephropathy, Focal Segmental Glomerulosclerosis
A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects
The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.
- Trial name
- NCT05942625
- Testing
- HS-10390 tablet
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Hansoh BioMedical R&D Company
Infection, Human Immunodeficiency Virus I, HIV Infection
A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients
This study is a 48-week study designed to evaluate the safety and efficacy of a fixed-dose combination tablet administered once-a-day versus the individual tablets administered twice-a-day within 3-drug combination regimens in…
- Trial name
- NCT00046176
- Testing
- abacavir/lamivudine, abacavir, lamivudine
- Where
- 56 sites in United States, Costa Rica and 2 more
- Volunteers
- 240 people
- Sponsor
- ViiV Healthcare
Asthma
Study to Investigate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Single & Repeat Doses of GSK2269557
The study will comprise three Parts: Part A will consist of two cohorts of healthy male volunteers to assess the safety, tolerability and pharmacokinetics of ascending single doses of nebulised GSK2269557.
- Trial name
- NCT01462617
- Testing
- GSK2269557
- Where
- United Kingdom
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Alzheimer's Disease
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and healthy elderly subjects.
- Trial name
- NCT01294540
- Testing
- Drug: E2609
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Chronic Hepatitis C, Hepatitis C Virus
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy
The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct…
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, HCV, Direct-Acting Antiviral Agent (DAA)-Experienced
- Trial name
- NCT02446717
- Testing
- ABT-493, ABT-530, ribavirin (RBV), ABT-493/ABT-530
- Volunteers
- 141 people
- Sponsor
- AbbVie
Diabetic Macular Edema
Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema
The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS)…
- Trial name
- VISTA DME (NCT01363440)
- Testing
- Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321), Macular Laser Photocoagulation
- Where
- 51 sites in United States
- Volunteers
- 466 people
- Sponsor
- Regeneron Pharmaceuticals
Alzheimer's Disease, Dementia
Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease
For many, Alzheimer's disease is the number one medical issue facing our aging society. It is a late onset neurodegenerative disease, frequently under diagnosed, that impairs memory and cognitive performance.
- Conditions
- Alzheimer's Disease, Dementia, Memory Loss, Cognitive Impairment
- Trial name
- NCT01354691
- Testing
- ladostigil hemitartrate
- Where
- 19 sites in Austria, Croatia and 3 more
- Volunteers
- 200 people
- Sponsor
- Avraham Pharmaceuticals Ltd
Allergic Conjunctivitis
Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
The purpose of this study was to assess the safety and efficacy of AL-4943A ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.
- Trial name
- NCT01479374
- Testing
- AL-4943A ophthalmic solution, AL-4943A vehicle, Olopatadine hydrochloride ophthalmic solution, 0.2%
- Volunteers
- 397 people
- Sponsor
- Alcon Research
Hepatitis B
Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patients With HBeAg(-) Chronic HBV
The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative
- Trial name
- NCT00313274
- Testing
- Clevudine
- Where
- 30 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Bukwang Pharmaceutical
Diabetes, Diabetes Mellitus, Type 2
Safety and Tolerability of Liraglutide in Japanese Subjects With Type 2 Diabetes
This trial is conducted in Japan. The aim of this trial is to assess the safety after multiple s.c. (subcutaneously) doses of liraglutide in Japanese subjects with type 2 diabetes.
- Trial name
- NCT01615978
- Testing
- liraglutide
- Where
- Japan
- Volunteers
- 15 people
- Sponsor
- Novo Nordisk A/S
Lymphoma, Non-Hodgkin
Study to Assess the Pharmacokinetics and Pharmacodynamics of GSK461364 in Subjects With Non-Hodgkins Lymphoma
This is a first time in human study that is being done to determine the maximum tolerated dose and initial pharmacokinetic parameters of GSK461364, given by IV, in adult subjects with solid tumors and Non-Hodgkins lymphoma.
- Trial name
- NCT00536835
- Testing
- GSK461364
- Where
- 3 sites in United Kingdom
- Volunteers
- 41 people
- Sponsor
- GlaxoSmithKline
Diabetes Mellitus, Type 1
Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin
- Trial name
- NCT02580591
- Testing
- Empagliflozin
- Where
- 189 sites in United States, Australia and 22 more
- Volunteers
- 977 people
- Sponsor
- Boehringer Ingelheim
Post-Herpetic Neuralgia
Efficacy and Safety of TRK-700 in Patient With Post-Herpetic Neuralgia
In Post-Herpetic Neuralgia(PHN) patients: To conduct an explorative investigation of the efficacy and safety of repeated oral doses of TRK-700 via a randomized double blind comparative study To measure the plasma concentration of…
- Trial name
- NCT02701374
- Testing
- TRK-700
- Where
- Japan
- Volunteers
- 184 people
- Sponsor
- Toray Industries, Inc
Amyotrophic Lateral Sclerosis (ALS)
Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis
Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis
- Trial name
- UNITE-ALS (NCT07023835)
- Testing
- 50 mg Usnoflast, 75 mg Usnoflast
- Where
- 49 sites in United States, Australia and 10 more
- Volunteers
- 240 people
- Sponsor
- Zydus Therapeutics Inc.
Rheumatoid Arthritis
Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis
This is a phase 2a study to be run in 2-3 countries in European Union involving 5-6 sites. It will enroll approximately 80 patients to ensure 40 randomized with active rheumatoid arthritis.
- Trial name
- NCT03368235
- Testing
- AZD9567, Prednisolone
- Where
- 5 sites in Netherlands, Sweden
- Volunteers
- 21 people
- Sponsor
- AstraZeneca
Rheumatoid Arthritis
Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 )
The purpose of this study is to asses the long term efficacy, safety and immunogenicity of ENERCEPTAN® in combination with Methotrexate for the treatment of patients with rheumatoid arthritis up to 104 weeks
- Trial name
- NCT03403140
- Testing
- Etanercept
- Where
- Argentina
- Volunteers
- 141 people
- Sponsor
- Gema Biotech S.A.
Kidney Neoplasm, Nephrectomy
Evaluation of 'RUS NE' in Robot-Assisted Partial Nephrectomy: Efficacy, Safety, and Stability
This study is a retrospective and prospective comparative study evaluating the efficacy, safety, and stability of the surgical navigation system 'RUS NE' in robot-assisted partial nephrectomy.
- Conditions
- Kidney Neoplasm, Nephrectomy, Surgical Navigation Systems, Renal Mass
- Trial name
- HTK_002 (NCT06945640)
- Testing
- RUS NE
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- Hutom Corp
Primary Immune Thrombocytopenia
The Safety and Tolerability of STSA-1301 Subcutaneous Injection in Healthy Subjects
A randomized, double-blind, placebo-controlled, single-ascending dose, phase Ia study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamics, and immunogenicity of STSA-1301 Subcutaneous Injection in healthy…
- Trial name
- NCT06148389
- Testing
- STSA-1301 subcutaneous injection
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
HCV Infection
A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype 1 Hepatitis C Virus (HCV) infection.
- Trial name
- NCT01193478
- Testing
- GS-5885
- Where
- 13 sites in United States
- Volunteers
- 71 people
- Sponsor
- Gilead Sciences