Clinical trials: PATIENT SAFETY
Bloody Diarrhea, STEC, Unspecified
Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS
The investigational medicinal product (IMP), INM004, proposes to neutralize the toxin in the bloodstream to prevent the interaction of the Stx with the specific receptor, by means of a polyclonal antibody to be administered upon…
- Conditions
- Bloody Diarrhea, STEC, Unspecified, Hemolytic-Uremic Syndrome, Pediatric Kidney Disease
- Trial name
- NCT04132375
- Testing
- INM004
- Where
- 7 sites in Argentina
- Volunteers
- 11 people
- Sponsor
- Inmunova S.A.
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
- Conditions
- Pulmonary Fibrosis, Progressive Pulmonary Fibrosis, Pulmonary Fibrosis Secondary to Systemic Sclerosis, Pulmonary Fibrosis, Interstitial Lung Disease
- Trial name
- NCT06329401
- Testing
- AP01
- Where
- 154 sites in United States, Argentina and 12 more
- Volunteers
- 398 people
- Sponsor
- Avalyn Pharma Inc.
Chondrosarcoma
A Study of PRO95780 in Patients With Advanced Chondrosarcoma (APM4171g)
This is a multicenter, open-label, Phase II trial designed to evaluate the efficacy and safety of PRO95780 when given as a single agent in patients with advanced chondrosarcoma.
- Trial name
- NCT00543712
- Testing
- PRO95780
- Where
- 4 sites in United States, Australia
- Volunteers
- 15 people
- Sponsor
- Genentech, Inc.
Ulcerative Colitis (UC)
Dose-Evaluation Study of the Efficacy and Safety of TLA Gut™ Leukapheresis Treatment in Patients With Ulcerative Colitis
An open-label, randomised, multi-centre, dose evaluation study of the efficacy and safety of TLA Gut™ leukapheresis treatment in patients with UC.
- Trial name
- NCT04550130
- Testing
- TLA Gut™
- Where
- Sweden
- Volunteers
- 12 people
- Sponsor
- TLA, Targeted Immunotherapies AB
Refractory Metastatic Colorectal Cancer, Solid Tumor
Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers
This Phase Ib/IIa study comprises a Main Study and a Study Extension. The Main Study has been designed according to a 3+3 Dose Escalation/dose Expansion design in refractory pMMR-MSS mCRC patients.
- Conditions
- Refractory Metastatic Colorectal Cancer, Solid Tumor, Metastatic Microsatellite-stable Colorectal Cancer, Mismatch Repair Protein Proficient
- Trial name
- NCT05205330
- Testing
- CR6086, AGEN2034
- Where
- 3 sites in Italy
- Volunteers
- 107 people
- Sponsor
- Rottapharm Biotech
Mechanically Ventilated ICU Patients
Effect of Homeopathic Remedy Kalium Bichromicum on Viscosity and Amount of Sputum Mechanically Ventilated ICU Patients.
The purpose of this study is to determine whether the homeopathic remedy Kali Bichromium is effective in reducing the amount of tracheal secretions in patients intubated with a conventional endotracheal tube and receiving…
- Trial name
- NCT00326365
- Testing
- Kali bichromicum 10-60 (C30)
- Where
- Israel
- Volunteers
- 56 people
- Sponsor
- Shaare Zedek Medical Center
GVHD
Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD
This study aims to determine whether the fecal microbiota transplant (FMT) capsule improves the response rate of GI-aGVHD in patients with glucocorticoid-refractory acute graft vs.
- Trial name
- NCT05094765
- Testing
- FMT
- Volunteers
- 15 people
- Sponsor
- Shenzhen Xbiome Biotech Co., Ltd.
Type 2 Diabetes Mellitus
Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise
Primary Objective: To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c (HbA1c) reduction in Chinese patients with type 2 diabetes (T2D) who have inadequate glycemic control on diet and…
- Trial name
- NCT03760965
- Testing
- sotagliflozin (SAR439954)
- Where
- 29 sites in China
- Volunteers
- 276 people
- Sponsor
- Sanofi
Gaucher Disease, Type 1 Gaucher Disease
A Long-Term Extension Study of AT2101 (Afegostat Tartrate) in Type 1 Gaucher Patients
This study evaluated the long-term safety and efficacy of afegostat tartrate in participants with Gaucher disease who were enrolled in a previous Phase 2 study of afegostat tartrate.
- Conditions
- Gaucher Disease, Type 1 Gaucher Disease, Gaucher Disease, Type 1
- Trial name
- NCT00813865
- Testing
- afegostat tartrate
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 8 people
- Sponsor
- Amicus Therapeutics
Rheumatoid Arthritis
Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis
Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments.
- Trial name
- NCT03139136
- Testing
- MBS2320
- Where
- 3 sites in Georgia, Moldova and 1 more
- Volunteers
- 121 people
- Sponsor
- Modern Biosciences Ltd
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.
Pancreas Cancer
To Assess the Safety of Continuous IV Administration of Plerixafor and Assess Impact on the Immune Microenvironment in Patients With Pancreatic, Ovarian and Colorectal Adenocarcinomas
A dose escalation trial to assess the safety of plerixafor in patients with advanced pancreatic, high grade serous ovarian and colorectal cancer.
- Trial name
- NCT03277209
- Testing
- Plerixafor
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 2 people
- Sponsor
- Weill Medical College of Cornell University
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