Clinical trials: Patient Safety
Iron Overload Due to Repeated Red Blood Cell Transfusions
Safety and Acceptability of Deferiprone Delayed Release Tablets in Patients With Systemic Iron Overload
Safety, tolerability, and acceptability of twice-daily dosing with deferiprone delayed-release (DR) tablets in patients with systemic iron overload.
- Trial name
- TWICE (NCT03802916)
- Testing
- Deferiprone DR tablets 1000 mg (Low dosage), Deferiprone DR tablets 1000 mg (High dosage)
- Where
- 5 sites in United States, Canada and 2 more
- Volunteers
- 30 people
- Sponsor
- ApoPharma
Irritable Bowel Syndrome Characterized by Constipation
Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.
- Trial name
- IBS-C (NCT02493452)
- Testing
- Plecanatide
- Where
- 191 sites in United States
- Volunteers
- 1,135 people
- Sponsor
- Bausch Health Americas, Inc.
Advanced Solid Malignancies, Malignant Lymphoma
Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when given daily to patients with advanced solid…
- Trial name
- NCT01588548
- Testing
- AZD1208
- Where
- 3 sites in Japan, United Kingdom
- Volunteers
- 43 people
- Sponsor
- AstraZeneca
Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma
Safety and Antitumor Activity Study of Loncastuximab Tesirine and Durvalumab in Diffuse Large B-Cell, Mantle Cell, or Follicular Lymphoma
The purpose of this phase 1 study is to evaluate the safety and anti-tumor activity of Loncastuximab Tesirine (ADCT-402) and Durvalumab in participants with Advanced Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, or…
- Conditions
- Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma
- Trial name
- NCT03685344
- Testing
- Loncastuximab Tesirine and Durvalumab
- Where
- 14 sites in United States, Spain
- Volunteers
- 13 people
- Sponsor
- ADC Therapeutics S.A.
HIV-1 Infection
Study of MK-1972 in Human Immunodeficiency Virus (HIV)-1 Infected Participants Who Have Not Previously Received Antiretroviral Therapy (MK-1972-003)
This is a two part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-1972 in participants with HIV-1 infections.
- Trial name
- NCT01353898
- Testing
- MK-1972
- Volunteers
- 12 people
- Sponsor
- Merck Sharp & Dohme LLC
Primary Axillary Hyperhidrosis
A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of…
- Trial name
- NCT03785587
- Testing
- Sofpironium Bromide Gel, 15%
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Botanix Pharmaceuticals
Muscular Dystrophy, Duchenne, Ambulatory Care
Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)
The aim of this Phase III study was to assess the efficacy of idebenone on pulmonary function, motor function, muscle strength and quality of life in patients with DMD.
- Trial name
- DELOS (NCT01027884)
- Testing
- Idebenone
- Where
- 23 sites in United States, Austria and 8 more
- Volunteers
- 65 people
- Sponsor
- Santhera Pharmaceuticals
Heterozygous Familial Hypercholesterolemia, Coronary Artery Disease
Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease
The purpose of this study is to determine whether mipomersen safely and effectively lowers low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial Hypercholesterolemia (HeFH) and coronary artery disease…
- Trial name
- RADICHOL II (NCT00706849)
- Testing
- mipomersen sodium
- Where
- 48 sites in United States, Canada
- Volunteers
- 124 people
- Sponsor
- Kastle Therapeutics, LLC
Hypertension, Hypercholesterolemia
Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in Japanese patients with both of hypertension…
- Conditions
- Hypertension, Hypercholesterolemia, Angina Pectoris
- Trial name
- NCT01190007
- Testing
- Caduet
- Where
- 20 sites in Japan
- Volunteers
- 159 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Metastatic Cancer, Solid Tumors
Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
This study is an open-label Phase 1/Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.
- Conditions
- Metastatic Cancer, Solid Tumors, Colorectal Cancer (CRC), Gastric Cancer
- Trial name
- NCT02903914
- Testing
- INCB001158, Pembrolizumab
- Where
- 20 sites in United States, Italy and 2 more
- Volunteers
- 260 people
- Sponsor
- Incyte Corporation
Osteoarthritis of the Knee
Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee
The purpose of this study is to assess the efficacy and safety of glucosamine and chondroitin sulfate association in the treatment of patients with osteoarthrosis of the knee.
- Trial name
- Artico (NCT00955552)
- Testing
- Glucosamine sulphate and chondroitin sulphate association, Cosamin DS® (Nutramax)
- Where
- 4 sites in Brazil
- Volunteers
- 100 people
- Sponsor
- Eurofarma Laboratorios S.A.
Rheumatoid Arthritis
A Study for Japanese Participants With Rheumatoid Arthritis (RA)
This study will evaluate the safety and tolerability of multiple doses of LY2127399 (tabalumab) in Japanese participants with RA. The study consists of a 20-week treatment period.
- Trial name
- NCT01253226
- Testing
- LY2127399 (Tabalumab)
- Where
- 10 sites in Japan
- Volunteers
- 32 people
- Sponsor
- Eli Lilly and Company
Acute Lung Injury, Acute Respiratory Distress Syndrome
Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II
The purpose of this study was to assess the safety, tolerability and preliminary efficacy of FP-1201 (Interferon Beta) in patients with Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).
- Trial name
- NCT00789685
- Testing
- Interferon Beta
- Where
- 8 sites in United Kingdom
- Volunteers
- 37 people
- Sponsor
- Faron Pharmaceuticals Ltd
Primary Immune Deficiency Disorder
Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06_002CR (NCT01199705).
- Trial name
- NCT01458171
- Testing
- Immune globulin subcutaneous (Human)
- Where
- 9 sites in Japan
- Volunteers
- 23 people
- Sponsor
- CSL Behring
Congestive Heart Failure
Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar
The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead.
- Trial name
- CELESTIAL (NCT00810264)
- Testing
- CRT Therapy - LV Lead Registry
- Where
- 86 sites in United States
- Volunteers
- 2,499 people
- Sponsor
- Biotronik, Inc.
Idiopathic Pulmonary Fibrosis
Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and…
- Trial name
- NCT00287716
- Testing
- Pirfenidone
- Where
- United States
- Volunteers
- 435 people
- Sponsor
- Genentech, Inc.
Prader-Willi Syndrome
Cannabidiol Oral Solution for the Treatment of Patients With Prader-Willi Syndrome
The primary objective of this study is to assess the efficacy of cannabidiol oral solution on hyperphagia-related behavior in patients with Prader-Willi Syndrome (PWS).
- Trial name
- NCT02844933
- Testing
- Cannabidiol
- Where
- 7 sites in United States
- Volunteers
- 7 people
- Sponsor
- Radius Pharmaceuticals, Inc.
Idiopathic Thrombocytopenic Purpura
IGIV Study for Chronic ITP Patients Ages 3-70
Idiopathic (immune) thrombocytopenic purpura (ITP) is an autoimmune disorder characterized by platelet destruction and thrombocytopenia (peripheral blood platelet count < 150 x 10^9/L).
- Trial name
- NCT00511147
- Testing
- IGIV3I Grifols 10%
- Where
- 45 sites in United States, Canada and 2 more
- Volunteers
- 64 people
- Sponsor
- Grifols Biologicals, LLC
Stage IV NSCLC
Safety and Tolerability Evaluation of Sintilimab in Combination With Radiation in Stage IV NSCLC Patients
This pilot phase I trial aims to investigate the safety and tolerability of anti-programmed cell death-1 (PD-1) monoclonal antibody Sintilimab (also called IBI308) in combination with concurrent stereotactic body radiation…
- Trial name
- NCT03812549
- Testing
- Sintilimab, stereotactic body radiation therapy, Low Dose Radiotherapy
- Where
- China
- Volunteers
- 29 people
- Sponsor
- Sichuan University
Type 2 Diabetes Mellitus
Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.
- Trial name
- NCT02227849
- Testing
- Canagliflozin (TA-7284), GLP-1 analogue
- Where
- 4 sites in Japan
- Volunteers
- 71 people
- Sponsor
- Tanabe Pharma Corporation
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