Clinical trials: System Safety
Ocular Itching, Ocular Allergy
Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis
The purpose of this study is to evaluate the efficacy and safety of four doses of PRO-118 ophthalmic solution ophthalmic solution compared with placebo, for the treatment of seasonal (SAC) and perennial (PAC) allergic…
- Conditions
- Ocular Itching, Ocular Allergy, Seasonal Allergic Conjunctivitis, Perennial Allergic Conjunctivitis
- Trial name
- PRO-118 (NCT01541904)
- Testing
- PRO-118 Ophthalmic Solution 0.015%, PRO-118 Ophthalmic Solution 0.015 %, PRO-118 Ophthalmic Solution 0.020 %
- Where
- 2 sites in Mexico
- Sponsor
- Laboratorios Sophia S.A de C.V.
Heart Transplant
Donors After Circulatory Death Heart Trial
To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
- Trial name
- NCT03831048
- Testing
- OCS Heart System, Cold Storage
- Where
- 25 sites in United States
- Volunteers
- 180 people
- Sponsor
- TransMedics
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Memory Loss
The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.
- Trial name
- NCT00293176
- Testing
- Donepezil Hydrochloride
- Where
- 54 sites in United States
- Volunteers
- 821 people
- Sponsor
- Eisai Inc.
Solid Tumor, Adult, Advanced Solid Tumors
IMX-110 in Patients With Advanced Solid Tumors
Phase 1 is an open-label, multi-center dose escalation/dose expansion study designed to assess the safety, tolerability and pharmacokinetics (PK) for the recommended phase 2 dose (RP2D) of IMX-110.
- Conditions
- Solid Tumor, Adult, Advanced Solid Tumors, Pancreatic Cancer, Breast Cancer
- Trial name
- NCT03382340
- Testing
- Imx-110
- Where
- 2 sites in United States, Australia
- Volunteers
- 70 people
- Sponsor
- Immix Biopharma Australia Pty Ltd
Type 2 Diabetes Mellitus
Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin
Primary Objective: To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as reflected by HbA1c during a…
- Trial name
- NCT01457911
- Testing
- Glimepiride and Metformin hydrochloride combination (HOE490), Glimepiride (HOE490)
- Where
- 22 sites in China
- Volunteers
- 244 people
- Sponsor
- Sanofi
Leukemia, Lymphocytic, Chronic, B-Cell
A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
The purpose of this study is to confirm the efficacy and safety of fludarabine phosphate administered with dose increasing in 6 cycles (1 cycle: 5 treatment days every 28 days) in untreated chronic lymphocytic leukemia (CLL)…
- Trial name
- NCT00220311
- Testing
- Fludarabine Phosphate (Fludara)
- Volunteers
- 10 people
- Sponsor
- Genzyme, a Sanofi Company
FSHD, FSHD1
Phase 2 Open-label Extension Study of AOC 1020 in Participants With Facioscapulohumeral Muscular Dystrophy (FSHD)
A Phase 2 Open-label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of AOC 1020 Administered Intravenously to Participants with Facioscapulohumeral Muscular Dystrophy (FSHD)
- Conditions
- FSHD, FSHD1, FSHD2, FMD
- Trial name
- FORTITUDE-OLE (NCT06547216)
- Testing
- AOC 1020
- Where
- 17 sites in United States, Canada and 1 more
- Volunteers
- 84 people
- Sponsor
- Avidity Biosciences, Inc.
Rheumatoid Arthritis
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent
This observational, prospective, multicenter study will evaluate the efficacy and safety of MabThera/Rituxan in participants with active rheumatoid arthritis and an inadequate response or intolerance to one anti-TNF therapy.
- Trial name
- NCT01641952
- Testing
- Rituximab
- Where
- Romania
- Volunteers
- 505 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis
This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).
- Trial name
- NCT00074438
- Testing
- methotrexate, rituximab, corticosteroids
- Volunteers
- 465 people
- Sponsor
- Genentech, Inc.
Stroke
Myomo e100 NeuroRobotic System Home Safety Study
Up to 25 subjects will use the Myomoe100 in the home setting under the distant supervision of an occupational therapist. We will look to see if they can perform functional activities safely without adverse events.
- Trial name
- NCT00820638
- Testing
- myomo e100
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Myomo
Carcinoma, Hepatocellular
A Safety, Tolerability, and Pharmacokinetics Study of Onartuzumab as Single Agent or in Combination With Sorafenib in Participants With Advanced Hepatocellular Carcinoma
This multicenter, open-label study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities of onartuzumab as single agent or in combination with sorafenib in participants with advanced hepatocellular…
- Trial name
- NCT01897038
- Testing
- Onartuzumab, Sorafenib
- Where
- 10 sites in United States, Hong Kong and 2 more
- Volunteers
- 9 people
- Sponsor
- Hoffmann-La Roche
Follicular Lymphoma
A Phase 2 Clinical Study of YY-20394 in Patients With Relapsed/Refractory Follicular Lymphoma
A Phase 2, single arm, open label clinical study to evaluate the efficacy, safety, tolerability and pharmacokinetics of YY-20394 as monotherapy in patients with relapsed/refractory follicular non-Hodgkin's lymphoma who have…
- Trial name
- NCT04379167
- Testing
- YY-20394
- Volunteers
- 140 people
- Sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
Type 2 Diabetes Mellitus
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
A Phase 2 study with two cohorts of differing doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes Mellitus (T2DM).
- Trial name
- NCT03244800
- Testing
- MEDI0382
- Where
- 5 sites in Germany
- Volunteers
- 65 people
- Sponsor
- MedImmune LLC
Atopic Dermatitis
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.
- Trial name
- NCT03011892
- Testing
- Ruxolitinib 0.15% Cream QD, Ruxolitinib 0.5% Cream QD, Ruxolitinib 1.5% Cream QD
- Where
- 52 sites in United States, Canada
- Volunteers
- 307 people
- Sponsor
- Incyte Corporation
Diabetic Neuralgia, Diabetic Neuropathies
Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain
This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD).
- Conditions
- Diabetic Neuralgia, Diabetic Neuropathies, Diabetic Neuropathy, Painful, Diabetic Polyneuropathy
- Trial name
- NCT00507936
- Testing
- ABT-894, Duloxetine
- Where
- 49 sites in United States, Canada and 5 more
- Volunteers
- 280 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Seasonal Allergic Rhinitis
A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Seasonal Allergic Rhinitis
This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of participants with moderate to severe SAR
- Trial name
- NCT07436234
- Testing
- AK139
- Where
- China
- Volunteers
- 111 people
- Sponsor
- Akeso
Waldenstrom's Macroglobulinemia
Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia
Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 90% of the patients with Waldenström's macroglobulinemia.
- Trial name
- 8400-401 (NCT02092909)
- Testing
- IMO-8400
- Where
- 10 sites in United States
- Volunteers
- 31 people
- Sponsor
- Idera Pharmaceuticals, Inc.
Rheumatoid Arthritis (RA)
Phase IIIB Subcutaneous Abatacept Monotherapy Study
To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept
- Trial name
- NCT00547521
- Testing
- abatacept, Methotrexate (MTX)
- Where
- 22 sites in United States, Australia and 2 more
- Volunteers
- 119 people
- Sponsor
- Bristol-Myers Squibb
Colon Cancer, Rectal Cancer
A Study of Ramucirumab or Icrucumab in Colorectal Cancer
The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard…
- Trial name
- NCT01111604
- Testing
- Ramucirumab, Icrucumab, mFOLFOX-6
- Where
- 17 sites in United States, Canada
- Volunteers
- 158 people
- Sponsor
- Eli Lilly and Company