Clinical trials: Patient Safety
Angioplasty, Cardiovascular Disease
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.
- Conditions
- Angioplasty, Cardiovascular Disease, Coronary Artery Disease, Coronary Heart Disease
- Trial name
- XP China SAS (NCT01894152)
- Testing
- XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
- Where
- United States
- Volunteers
- 2,002 people
- Sponsor
- Abbott Medical Devices
Eosinophilic Esophagitis
A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis
This is a Phase 2/3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult and adolescent patients with active eosinophilic…
- Trial name
- KRYPTOS (NCT04322708)
- Testing
- lirentelimab (AK002)
- Where
- 78 sites in United States, Australia and 1 more
- Volunteers
- 277 people
- Sponsor
- Allakos Inc.
Allergic Rhinitis Due to Grass Pollens
Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis
The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.
- Trial name
- NCT00955825
- Testing
- 300 IR
- Where
- 19 sites in United States
- Volunteers
- 473 people
- Sponsor
- Stallergenes Greer
Thrombocytopenia Associated With Liver Disease
Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure
This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease.
- Trial name
- NCT01976104
- Testing
- avatrombopag (lower baseline platelet count), avatrombopag (higher baseline platelet count)
- Where
- 120 sites in United States, Argentina and 15 more
- Volunteers
- 204 people
- Sponsor
- Eisai Inc.
Nonalcoholic Steatohepatitis (NASH)
Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.
- Trial name
- NCT02443116
- Testing
- NGM282
- Where
- 22 sites in United States, Australia and 1 more
- Volunteers
- 254 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Homozygous Familial Hypercholesterolemia
Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor
The primary objective of this study is to evaluate the safety and tolerability of 4 doses of lomitapide (AEGR-733; BMS-201038) given as an initial low dose and then escalated through an additional 3 dose levels over a 16-week…
- Trial name
- NCT01556906
- Testing
- Lomitapide
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Hyperparathyroidism, Secondary
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on…
- Trial name
- NCT02102204
- Testing
- Etelcalcetide
- Where
- 228 sites in United States, Australia and 22 more
- Volunteers
- 902 people
- Sponsor
- Amgen
Benign Prostatic Hypertrophy
Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
Benign Prostatic Hyperplasia (BPH) is the most common hyperplastic disease occuring in human males over the age of 50 which increases in prevalence with age and 40% of males reported moderate or severe urinary symptoms of…
- Trial name
- AEZS-102-Z041 (NCT00670306)
- Testing
- Cetrorelix Pamoate
- Where
- 69 sites in United States, Canada
- Volunteers
- 528 people
- Sponsor
- AEterna Zentaris
Advanced Metastatic Clear Cell Renal Cell Carcinoma (CCRCC)
SLM + Axitinib for Clear Cell RCC
This phase I trial studies the side effects and best dose of L-selenomethionine when given together with axitinib in treating patients with clear cell renal cell carcinoma that has spread from the primary site (place where it…
- Trial name
- NCT02535533
- Testing
- Selenomethionine (SLM), Axitinib
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Mohammed Milhem
Breast Cancer
A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer
This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive…
- Trial name
- NCT01196052
- Testing
- Trastuzumab emtansine
- Where
- 44 sites in United States, Belgium and 6 more
- Volunteers
- 153 people
- Sponsor
- Hoffmann-La Roche
Huntington Disease
Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease
WVE-HDSNP1-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120101 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism…
- Trial name
- NCT04617847
- Testing
- WVE-120101
- Where
- 18 sites in Australia, Canada and 5 more
- Volunteers
- 27 people
- Sponsor
- Wave Life Sciences USA, Inc.
Hypertension
Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension
This study will evaluate the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension
- Trial name
- NCT00413049
- Testing
- Valsartan/amlodipine 80/5 mg, Amlodipine 5 mg
- Where
- 12 sites in China
- Volunteers
- 698 people
- Sponsor
- Novartis
Paroxysmal Nocturnal Hemoglobinuria
Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Study, Assessing Multiple LNP023 Doses in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria
This was a Phase II randomized, open-label, multicenter, efficacy, safety, pharmacokinetic and pharmacodynamic study assessing four iptacopan doses in adult Paroxysmal nocturnal hemoglobinuria (PNH) patients with active hemolysis…
- Trial name
- NCT03896152
- Testing
- LNP023
- Where
- 5 sites in Malaysia, Singapore and 2 more
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Lymphocytic Leukemia
A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia
This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic…
- Trial name
- NCT01905943
- Testing
- Bendamustine, Chlorambucil, Cyclophosphamide
- Where
- 174 sites in Argentina, Belgium and 29 more
- Volunteers
- 979 people
- Sponsor
- Hoffmann-La Roche
Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation
Study of Efficacy and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C- Mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.
This study aims to evaluate the antitumor activity and safety of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a KRAS G12C…
- Trial name
- KontRASt-06 (NCT05445843)
- Testing
- JDQ443
- Where
- 45 sites in United States, Argentina and 17 more
- Volunteers
- 95 people
- Sponsor
- Novartis Pharmaceuticals
Acute Ischemic Stroke
Safety of DS-1040b in Acute Ischemic Stroke Patients Treated With Thrombectomy
The aim of this study is to find out if DS-1040b is safe and tolerable in acute ischemic stroke patients with thrombectomy. Four groups will receive different doses of DS-1040b by intravenous infusion for 6 hours.
- Trial name
- NCT03198715
- Testing
- DS1040b
- Where
- 20 sites in Japan
- Volunteers
- 42 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Osteoarthritis, Knee
Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee
Phase 2 multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, and local tolerability of G001 topical gel compared to matching Vehicle topical gel in patients with…
- Trial name
- NCT05007808
- Testing
- G001 Topical Gel, Vehicle
- Where
- 10 sites in Canada
- Volunteers
- 210 people
- Sponsor
- BUZZZ Pharmaceuticals Limited
Acute Myeloid Leukemia
Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113
This is a Phase Ib Study to determine the Maximum Tolerated Dose (MTD) of Venetoclax in combination with Gemtuzumab Ozogamicin(GO) in subjects with relapsed/refractory acute myeloid leukemia.
- Trial name
- NCT04070768
- Testing
- Gemtuzumab Ozogamicin, Venetoclax
- Where
- 4 sites in United States
- Volunteers
- 18 people
- Sponsor
- John Quigley
Hemophilia
Safety and Efficacy of FVIIa to Prevent Excessive Bleeding in Hemophilia Patients With Inhibitors Undergoing Major Surgery
This is an interventional, prospective, international, multicenter, single-arm, Phase 3, and sequential efficacy and safety study in adolescents and adults with congenital hemophilia A or B with inhibitors to factor VIII (FVIII)…
- Trial name
- SCOPE HIM (NCT05695391)
- Testing
- Coagulation Factor VIIa (Recombinant)
- Where
- 15 sites in United States, Malaysia and 4 more
- Volunteers
- 2 people
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Gastric Cancer
A Safety and Efficacy Study in Patients With Gastric Cancer
This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced gastric cancer previously untreated with…
- Trial name
- NCT00400179
- Testing
- S-1/Cisplatin, 5-FU/cisplatin
- Where
- 33 sites in United States, Canada
- Volunteers
- 1,053 people
- Sponsor
- Taiho Oncology, Inc.
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