Clinical trials: Patient Safety
Exocrine Pancreatic Insufficiency
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis.
- Trial name
- NCT02598128
- Testing
- RELiZORB
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- Alcresta Therapeutics, Inc.
Ovarian Cancer, Healthy Volunteers
Safety and Biodistribution of Technetium Tc 99m EC20 in Normal Volunteers and Ovarian Cancer Patients
Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four subjects with known or suspected ovarian…
- Trial name
- NCT01689636
- Testing
- Tc 99m EC20
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Endocyte
Schizophrenia, Schizoaffective Disorder
A Safety and Pharmacokinetic Study of ER OROS Paliperidone in Pediatric Patients With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
The purposes of this study are to characterize the pharmacokinetics of paliperidone after single- and multiple-dose administration of paliperidone ER in children and adolescent patients (>= 10 to <= 17 years of age) with…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
- Trial name
- NCT00796081
- Testing
- ER OROS paliperidone, paliperidone ER
- Volunteers
- 25 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Coronary Artery Disease
Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent for the Treatment of De Novo Coronary Artery Lesions
The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8 sirolimus-eluting stent system in the treatment of patients with de novo coronary artery lesions.
- Trial name
- NCT02360709
- Testing
- CRE8 sirolimus-eluting stent
- Where
- China
- Volunteers
- 800 people
- Sponsor
- CID S.p.A.
Rheumatoid Arthritis
An Open-label Study of CND261 in Seropositive Rheumatoid Arthritis
The purpose of the study is to evaluate the safety and efficacy of CND261 in patients with seropositive rheumatoid arthritis.
- Trial name
- NCT07052032
- Testing
- CND261
- Where
- 2 sites in Moldova, Ukraine
- Volunteers
- 47 people
- Sponsor
- Candid Therapeutics
Spinal and Bulbar Muscular Atrophy
Safety, Tolerability, and Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy
The purpose of this study was to determine if BVS857 is safe, tolerable and increases thigh muscle thickness in patients with spinal bulbar and muscular atrophy (SBMA).
- Trial name
- NCT02024932
- Testing
- BVS857
- Where
- 6 sites in United States, Denmark and 2 more
- Volunteers
- 37 people
- Sponsor
- Novartis Pharmaceuticals
Neoplasms, Solid Tumors
Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Advanced or Metastatic Solid Tumors
This is a Phase 1 dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in patients with advanced or metastatic solid tumors.
- Conditions
- Neoplasms, Solid Tumors, Metastases
- Trial name
- NCT00569036
- Testing
- BMS-754807
- Where
- 5 sites in Australia
- Volunteers
- 63 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis C
Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24…
- Trial name
- NCT01359644
- Testing
- PSI-7977, Daclatasvir, Ribavirin
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 350 people
- Sponsor
- Bristol-Myers Squibb
Atopic Dermatitis
A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B)
The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study participants and after repeat intravenous dosing in study participants…
- Trial name
- NCT05277571
- Testing
- UCB1381
- Where
- 16 sites in United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Advanced Liver Cancers
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available…
- Trial name
- MORPHEUS-LIVER (NCT04524871)
- Testing
- Atezolizumab, Bevacizumab 15 mg/kg, Tiragolumab
- Where
- 32 sites in United States, China and 5 more
- Volunteers
- 518 people
- Sponsor
- Hoffmann-La Roche
Rett Syndrome, RTT
Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome
To evaluate the efficacy of cannabidiol oral solution (GWP42003-P, CBD-OS) in reducing symptom severity when compared with placebo, in participants with Rett syndrome.
- Trial name
- ARCH (NCT03848832)
- Testing
- GWP42003-P
- Where
- 26 sites in United States, Italy and 2 more
- Volunteers
- 29 people
- Sponsor
- Jazz Pharmaceuticals
Frailty
A Study of Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty
The goal of this phase I/II clinical trial is to evaluate the safety and tolerability of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product StromaForte in patients with aging frailty.
- Trial name
- NCT06070532
- Testing
- Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)
- Where
- The Bahamas
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cellcolabs Clinical LTD.
Recurrent Glioblastoma
A Study of BL-B01D1 in Patients With Recurrent Glioblastoma
This is an open-label, multicenter, phase II study to evaluate the safety, efficacy, and pharmacokinetic characteristics of BL-B01D1 for Injection in patients with recurrent glioblastoma.
- Trial name
- NCT06598787
- Testing
- BL-B01D1 for Injection
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Primary Hypercholesterolemia
Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia
The purpose of this study is to evaluate efficacy and safety of HL140 in patients with primary hypercholesterolemia.
- Trial name
- NCT03571087
- Testing
- HL140 5/10, HL140 10/10, HL140 20/10
- Volunteers
- 374 people
- Sponsor
- Hanlim Pharm. Co., Ltd.
Idiopathic Pulmonary Fibrosis
A Phase II Study to Evaluate the Efficacy and Safety of SYH2059 Tablets in Adult Patients With Idiopathic Pulmonary Fibrosis
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It Aims aims to evaluate the efficacy and safety of different doses of SYH2059 tablets compared with placebo in adult patients with IPF, observe…
- Trial name
- NCT07600021
- Testing
- SYH2059 Tablets
- Volunteers
- 156 people
- Sponsor
- InnovStone Therapeutics Limited
Advanced and Metastatic Breast Cancer
Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer
This dose finding/extension study was designed originally to consist of three parts: Part A was intended to identify the MTD of the AZD2014/ palbociclib combination on a background of fulvestrant (referred to as the triplet) in…
- Trial name
- PASTOR (NCT02599714)
- Testing
- AZD2014, Palbociclib, Fulvestrant
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 54 people
- Sponsor
- AstraZeneca
Chronic Obstructive Pulmonary Disease
A Study to Assess Safety, Tolerability and Pharmacokinetics of of AZD6553 in Healthy Volunteers and Patients With Chronic Obstructive Pulmonary Disease (COPD)
AZD6553 is a new drug being developed as a possible treatment for patients with chronic obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the…
- Trial name
- NCT01068184
- Testing
- AZD6553
- Where
- United Kingdom
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Type 2 Diabetes Mellitus
A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period
This is a prospective, interventional, single arm, multicenter, phase 4 study to evaluate the clinical efficacy and safety of initiating Insulin glargine U300 in insulin-naive patients or switching from any other basal insulin to…
- Trial name
- INITIATION (NCT05002933)
- Testing
- Insulin glargine 300 U/ml
- Where
- China
- Volunteers
- 570 people
- Sponsor
- Sanofi
Differentiated Thyroid Cancer (DTC)
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer
The purpose of this study is to assess the efficacy and safety of dabrafenib in combination with trametinib for treating adult patients with locally advanced or metastatic Differentiated Thyroid Cancer (DTC) harboring the…
- Trial name
- NCT04940052
- Testing
- Dabrafenib, Trametinib
- Where
- 41 sites in United States, Argentina and 9 more
- Volunteers
- 153 people
- Sponsor
- Novartis Pharmaceuticals
Acquired Bleeding Disorder, Trauma
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and…
- Trial name
- CONTROL (NCT00184548)
- Testing
- eptacog alfa (activated)
- Where
- 14 sites in United States, Brazil and 12 more
- Volunteers
- 554 people
- Sponsor
- Novo Nordisk A/S