Clinical trials: Patient Safety
Dry Eye Syndrome, Dry Eye
Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye
Thymosin Beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide that is found in a variety of tissues. Tβ4 promotes/accelerates wound repair in dermal, ocular, and cardiac animal models.
- Trial name
- NCT01387347
- Testing
- Thymosin beta 4
- Volunteers
- 72 people
- Sponsor
- ReGenTree, LLC
Carcinoma, Non-Small-Cell Lung
Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
The objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring a…
- Trial name
- NCT02208843
- Testing
- Afatinib
- Where
- 21 sites in Egypt, Malaysia and 5 more
- Volunteers
- 60 people
- Sponsor
- Boehringer Ingelheim
Diabetic Macular Edema (DME)
Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
This is a Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in comparison with Eylea in Patients with Diabetic Macular Edema
- Trial name
- NCT04739306
- Testing
- CT-P42, Eylea
- Where
- Slovakia
- Volunteers
- 348 people
- Sponsor
- Celltrion
Primary Open Angle Glaucoma (POAG)
A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial
The purpose of this study is to evaluate the long-term safety of the CyPass Micro-Stent in subjects who completed Study Protocol TMI-09-01, COMPASS Trial.
- Trial name
- COMPASS-XT (NCT02700984)
- Testing
- CyPass Micro-Stent, Cataract Surgery
- Where
- 22 sites in United States
- Volunteers
- 282 people
- Sponsor
- Alcon Research
Head and Neck Neoplasm, Prostatic Neoplasm
Study Of PF-00562271, Including Patients With Pancreatic, Head And Neck, Prostatic Neoplasms
Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (FAK) inhibitor PF-00562271 in patients with positive Positron Emission Tomography [PET] scans due to advanced non-hematologic…
- Conditions
- Head and Neck Neoplasm, Prostatic Neoplasm, Pancreatic Neoplasm
- Trial name
- NCT00666926
- Testing
- PF00562271
- Where
- 4 sites in United States, Australia and 1 more
- Volunteers
- 99 people
- Sponsor
- Verastem, Inc.
Neovascular Age-related Macular Degeneration (nAMD)
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe
This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.
- Trial name
- NCT05161806
- Testing
- SOK583A1 (40 mg/mL), Prefilled Syringe (PFS)
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Sandoz
Rheumatoid Arthritis
Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
Main Study: Primary Objective: Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA). Secondary Objective: Assess the long term efficacy of sarilumab in participants with RA.
- Trial name
- NCT01146652
- Testing
- SAR153191 (REGN88)
- Where
- 335 sites in United States, Argentina and 38 more
- Volunteers
- 2,023 people
- Sponsor
- Sanofi
Renal Cell Carcinoma
A Study Evaluating the Efficacy and Safety of Sunitinib With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer (SABRE-R)
This is a Phase II, multicenter, randomized, blinded, placebo-controlled study designed to evaluate the safety and efficacy of combining bevacizumab with sunitinib relative to placebo with sunitinib in patients with metastatic…
- Trial name
- NCT00491738
- Testing
- bevacizumab, sunitinib
- Volunteers
- 16 people
- Sponsor
- Genentech, Inc.
Major Cutaneous Abscess, Cellulitis
A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study
Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.
- Conditions
- Major Cutaneous Abscess, Cellulitis, Erysipelas
- Trial name
- NCT01519778
- Testing
- TR701 FA
- Where
- 10 sites in United States
- Volunteers
- 200 people
- Sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Glaucoma, Open-Angle, Ocular Hypertension
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.
- Trial name
- NCT01217606
- Testing
- bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy), Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
- Where
- Brazil
- Volunteers
- 185 people
- Sponsor
- Allergan
Rheumatoid Arthritis
Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis
This trial will test the hypothesis that the administration of CF101, a novel anti-inflammatory agent, to patients with rheumatoid arthritis and high A3AR expression at baseline will relieve signs and symptoms of the disease.
- Trial name
- NCT01034306
- Testing
- CF101
- Where
- 5 sites in Bulgaria, Israel
- Volunteers
- 79 people
- Sponsor
- Can-Fite BioPharma
Trypanosomiasis, African, Sleeping Sickness
Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense
The ultimate goal of this study is to show that fexinidazole offers an alternative over the existing treatments of Human African trypanosomiasis due to Trypanosoma brucei rhodesiense (r-HAT): melarsoprol in patients with stage 2…
- Conditions
- Trypanosomiasis, African, Sleeping Sickness, Trypanosoma Brucei Rhodesiense; Infection
- Trial name
- NCT03974178
- Testing
- Fexinidazole
- Where
- 2 sites in Malawi, Uganda
- Volunteers
- 45 people
- Sponsor
- Drugs for Neglected Diseases
Rheumatoid Arthritis
A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis
This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis.
- Trial name
- NCT01194414
- Testing
- tocilizumab SC, tocilizumab IV, Disease-modifying antirheumatic drugs (DMARDs)
- Where
- 216 sites in United States, Argentina and 24 more
- Volunteers
- 1,262 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus, Type 2
Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes
The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum…
- Trial name
- NCT01778049
- Testing
- BI 10773, BI 10773 / BI 1356
- Where
- 114 sites in United States, Argentina and 9 more
- Volunteers
- 708 people
- Sponsor
- Boehringer Ingelheim
Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304)
Symptomatic NOH in patients with primary autonomic failure is thought to be a consequence of norepinephrine depletion leading to a diminished capacity to effect an appropriate cardiovascular response to an orthostatic challenge…
- Conditions
- Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency, Non-Diabetic Neuropathy, Neurogenic Orthostatic Hypotension
- Trial name
- NOH304 (NCT01132326)
- Testing
- Droxidopa
- Volunteers
- 350 people
- Sponsor
- Chelsea Therapeutics
HIV-1 Infection
A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)
This is a study to evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of doravirine (MK-1439) as monotherapy in antiretroviral therapy (ART)-naïve, HIV-1-infected participants.
- Trial name
- NCT01466985
- Testing
- Doravirine
- Volunteers
- 18 people
- Sponsor
- Merck Sharp & Dohme LLC
Actinic Keratosis
A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis
Part 1: To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days Part 2: To evaluate efficacy of two formulations of LEO 43204 in two doses after once…
- Trial name
- NCT01922050
- Testing
- LEO 43204 Formulation 1, LEO 43204 Formulation 2, LEO 43204 Formulation 1 Dose X
- Where
- 25 sites in United States, Canada
- Volunteers
- 320 people
- Sponsor
- LEO Pharma
Hypertension
Open-Label Extension Study of Patients Previously Enrolled in Study CIN-107-124
This is a Phase 2, multicenter, open-label extension (OLE) study to evaluate the long-term safety, tolerability, and effectiveness of CIN-107 for up to 52 weeks in patients with HTN who have completed Part 1 or Part 2 of Study…
- Trial name
- NCT05459688
- Testing
- CIN-107
- Where
- 36 sites in United States
- Volunteers
- 175 people
- Sponsor
- AstraZeneca
Urea Cycle Disorder
Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCDs)
This is a randomized, controlled, open-label parallel arm study to assess the safety, tolerability, pharmacokinetics and ammonia control, of RAVICTI® as compared to Sodium phenylbutyrate (NaPBA) in urea cycle disorder subjects…
- Trial name
- NCT03335488
- Testing
- RAVICTI, NaPBA
- Where
- 11 sites in United States, Italy and 2 more
- Volunteers
- 16 people
- Sponsor
- Amgen
Multiple Myeloma
Safety and Dose Determining Multi-dose Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma
This Phase I/IIa clinical study is to test safety and anti-tumor activity of BT062 to define the best dose in treating patients with relapsed or refractory multiple myeloma with multiple doses of BT062.
- Trial name
- NCT01001442
- Testing
- BT062
- Where
- 5 sites in United States
- Volunteers
- 35 people
- Sponsor
- Biotest Pharmaceuticals Corporation
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