Clinical trials: Patient Safety
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase.
- Trial name
- NCT02279498
- Testing
- Liprotamase, porcine (pig) PERT
- Where
- 54 sites in United States, Canada and 5 more
- Volunteers
- 128 people
- Sponsor
- Anthera Pharmaceuticals
Ovarian Cancer, Fallopian Tube Cancer
A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian cancer will respond to first-line…
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Trial name
- NCT01610206
- Testing
- Gemcitabine, pazopanib
- Where
- 8 sites in United States
- Volunteers
- 148 people
- Sponsor
- Linda R Duska
Atopic Dermatitis
Study of Dupilumab in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis
The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).
- Trial name
- NCT01548404
- Testing
- Dupilumab
- Where
- 21 sites in Czechia, France and 3 more
- Volunteers
- 109 people
- Sponsor
- Regeneron Pharmaceuticals
Acute Spinal Cord Injury
AC105 in Patients With Acute Traumatic Spinal Cord Injury
The principal aim of this study was to establish the feasibility of rapid administration, safety, and tolerability of AC105 in patients with acute spinal cord injury.
- Trial name
- AC105 (NCT01750684)
- Testing
- AC105
- Volunteers
- 15 people
- Sponsor
- Acorda Therapeutics
Autism
Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism
The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.
- Trial name
- NCT00872898
- Testing
- Memantine - Extended Release (ER)
- Where
- 17 sites in United States
- Volunteers
- 124 people
- Sponsor
- Forest Laboratories
Nonalcoholic Steatohepatitis (NASH)
Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis
This is a phase II study of of Leronlimab (PRO 140)-Humanized monoclonal antibody to CCR5 in patients with Nonalcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT04521114)
- Testing
- leronlimab 700 mg, leronlimab 350 mg
- Where
- 7 sites in United States
- Volunteers
- 87 people
- Sponsor
- CytoDyn, Inc.
Iron Deficiency Anemia Treatment, Chronic Kidney Disease(CKD)
Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis
The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.
- Trial name
- NCT01227616
- Testing
- Ferumoxytol, Iron Sucrose
- Where
- 43 sites in United States, Canada and 1 more
- Volunteers
- 296 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Advanced Non-Small Cell Lung Cancer
Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India
Lorlatinib is a third-generation, oral, reversible, ATP-competitive, macrocyclic TKI of ALK and ROS1. Lorlatinib was specifically designed to penetrate the CNS and to overcome known secondary resistance mutations in the ALK…
- Trial name
- NCT04541706
- Testing
- Lorlatinib
- Where
- 12 sites in India
- Volunteers
- 100 people
- Sponsor
- Pfizer
Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD).
- Trial name
- NCT03118765
- Testing
- GSP304 (tiotropium bromide) Inhalation Solution, Spiriva® Respimat® inhalation spray
- Where
- 25 sites in United States
- Volunteers
- 155 people
- Sponsor
- Glenmark Specialty S.A.
Coronavirus
Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19)
This multi-center, open-label, 2 arm parallel-group, randomized, interventional prospective exploratory study in 40 patients aimed to evaluate safety and explore putative clinical benefits of Silmitasertib 1000 mg BID dose in…
- Trial name
- CX4945 (NCT04668209)
- Testing
- Silmitasertib
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- University of Arizona
Breast Neoplasms, Breast Cancer
Chloroquine With Taxane Chemotherapy for Advanced or Metastatic Breast Cancer After Anthracycline Failure (CAT)
The major purpose of this research study is to better understand how therapy works on different patients. This study is being offered to patients with a diagnosis of advanced or metastatic breast cancer who have failed…
- Trial name
- CAT (NCT01446016)
- Testing
- Paclitaxel, Docetaxel, Abraxane
- Where
- 3 sites in United States
- Volunteers
- 38 people
- Sponsor
- The Methodist Hospital Research Institute
Relapsing Remitting Multiple Sclerosis (RRMS)
Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod
This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.
- Trial name
- TOFIINGO (NCT01499667)
- Testing
- Fingolimod
- Where
- 44 sites in Australia, Austria and 9 more
- Volunteers
- 142 people
- Sponsor
- Novartis Pharmaceuticals
End Stage Renal Disease Requiring Hemodialysis
Factor XI LICA to Reduce Events Such as Heart Attack and Stroke in Patients Whose Kidneys Are no Longer Able to Work as They Should and Require Treatment to Filter Wastes From the Blood: Focus is on the Safety of BAY2976217 and the Way the Body Absorbs, Distributes and Removes the Study Drug
Patients whose kidneys are no longer able to work as they should and require treatment to filter wastes from the blood (hemodialysis) are at high risk for blood clots that form in blood vessels (thrombosis) blocking blood flow…
- Trial name
- RE-THINc ESRD (NCT04534114)
- Testing
- Fesomersen sodium (BAY2976217)
- Where
- 69 sites in United States, Belgium and 13 more
- Volunteers
- 307 people
- Sponsor
- Bayer
Fabry Disease
Open-label Long-term Safety Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease Who Have Completed a Previous AT1001 Study
Study to evaluate the long-term safety, tolerability, and pharmacodynamics (PD) of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease
- Trial name
- NCT00526071
- Testing
- migalastat HCl
- Where
- 8 sites in United States, Australia and 3 more
- Volunteers
- 23 people
- Sponsor
- Amicus Therapeutics
Atherosclerotic Cardiovascular Disease
Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients
This study aims to confirm the effectiveness of ezetimibe add-on therapy on LDL-C levels compared to atorvastatin monotherapy, especially in very high-risk patients.
- Trial name
- BETTER (NCT05761444)
- Testing
- Atozet 10/40 mg or 10/80 mg, Lipitor 40 mg or 80 mg
- Where
- 7 sites in South Korea
- Volunteers
- 137 people
- Sponsor
- Organon and Co
Transplant-Associated Thrombotic Microangiopathy
A Study of Pegcetacoplan for Patients With Transplant-associated Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplantation
The purpose of the study was to assess pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and safety of pegcetacoplan in patients with TA-TMA after HSCT.
- Trial name
- NCT05148299
- Testing
- Pegcetacoplan
- Where
- 14 sites in United States, France and 3 more
- Volunteers
- 12 people
- Sponsor
- Swedish Orphan Biovitrum
Type II Hyperlipidemia
A Safety and Efficacy Study of DRL-17822, a Cholesteryl Ester Transfer Protein (CETP) Inhibitor, in Patients With Abnormal Cholesterol Levels
The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein cholesterol (LDL-C) in people with abnormal…
- Trial name
- NCT01388816
- Where
- 12 sites in Italy, Poland and 1 more
- Volunteers
- 176 people
- Sponsor
- Dr. Reddy's Laboratories Limited
COPD
Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen
The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients with moderate COPD who switch from their…
- Trial name
- NCT01985334
- Testing
- Glycopyrronium, SABA, LABA
- Where
- 542 sites in Austria, Belgium and 21 more
- Volunteers
- 4,389 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Evaluation of Tiotropium 2.5 and 5 µg Once Daily Delivered Via the Respimat Inhaler Compared to Placebo in Patient With Moderate to Severe Persistent Asthma
The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over a 52-week treatment period as compared to placebo.
- Trial name
- NCT01340209
- Testing
- Tiotropium Respimat
- Where
- 55 sites in Japan
- Volunteers
- 285 people
- Sponsor
- Boehringer Ingelheim
Cystic Fibrosis
A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients
The purpose of this research study is to test the pharmacokinetics, safety, and tolerability of an intravenous infusion of a drug called Ganite (gallium nitrate) in patients with cystic fibrosis.
- Trial name
- NCT01093521
- Testing
- 100 mg/m2 dose, 200 mg/m2 dose
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Washington
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