Clinical trials: PH1
Myeloproliferative Neoplasm
Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of MNP Ph1-
Patients with myeloproliferative neoplasms Philadelphia chromosome negative (MPNsPh1-) such as Essential thrombocytosis (ET), Polycythemia vera (PV) and Primary Myelofibrosis (PMF) have a higher risk of arterial or deep-vein…
- Trial name
- MICROP-SMP (NCT02862366)
- Testing
- Blood sampling
- Where
- 3 sites in France
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Lille Catholic University
Healthy Subjects
A Ph 1 Study of Epanova® in Healthy Chineses
The purpose of this study is to explore the safety, tolerability, and PK of single and multiple doses of Epanova in healthy male and female Chinese subjects and to allow comparison of these parameters with the Western population…
- Trial name
- NCT03574142
- Testing
- Epanova
- Where
- China
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Malignant Solid Tumour
Ph1 Administration of VSV-IFNβ-NIS Monotherapy and in Combination With Avelumab in Pts With Refractory Solid Tumors
This is a three-part open label phase 1 study designed to determine the safety profile, MTD, PK and tumor and biomarker response after IT or IV administration of a single dose of VSV-IFNβ-NIS, or combined IT followed by IV…
- Trial name
- NCT02923466
- Testing
- VSV-IFNβ-NIS, VSV-IFNβ-NIS and avelumab
- Where
- 6 sites in United States
- Volunteers
- 76 people
- Sponsor
- Vyriad, Inc.
Anthrax
Ph1 Study of Valortim and Doxycycline in Humans
The purpose of this study is to evaluate the safety and tolerability of short-term dosing of IV doxycycline when administered concomitantly with IV Valortim in normal healthy human subjects.
- Trial name
- NCT00964834
- Testing
- Doxycycline and Valortim
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- PharmAthene, Inc.
HIV-1-infection, ART
Ph1 Study of FT538 Alone and With Vorinostat for Persistent Low-Level HIV Viremia
This is a single center Phase I clinical trial of FT538 administered intravenously (IV) once every 14 days for 4 consecutive doses for the reduction of the HIV reservoir in lymphoid tissue of HIV-infected individuals receiving…
- Conditions
- HIV-1-infection, ART, Cd4+ Lymphocyte Deficiency, Lymphoid Tissue; Infection
- Trial name
- NCT05700630
- Testing
- FT538, Vorinostat
- Where
- United States
- Sponsor
- Masonic Cancer Center, University of Minnesota
HER2 Negative Metastatic Breast Cancer
Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol, and has been used to treat patients that have cancers…
- Trial name
- NCT01948843
- Testing
- ADI-PEG 20
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Polaris Group
Metastatic Cancer, Unresectable Solid Tumor
CSB-321 Ph 1 in Immunotherapy for the Treatment of Cancer
Single-center with the option to expand to multi-center, international, open label, non-randomized, multiple-dose, multi-cohort study, in participants with metastatic or unresectable cancer.
- Trial name
- NCT07057349
- Testing
- [18F]CSB-321
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Cytosite Biopharma Inc.
Primary Hyperoxaluria Type 1, Idiopathic Hypercalciuria
IDENTIFICATION OF A MULTI-ANALYTE PROFILE FOR PRIMARY HYPEROXALURIA AND COMPARISON WITH HEALTHY SIBLINGS AND IDIOPATHIC HYPERCALCIURIA
The aim of this study is to know the difference between protein profiles (multi-analyte profile) of PH1 patients, idiopathic hypercalciuria (IH) patients and PH1 patients 'siblings.
- Trial name
- PH1 (NCT02830009)
- Testing
- Urines samples, Blood sample
- Where
- France
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
GVHD, Chronic
TDI01 Suspension in the Treatment of Chronic Graft-versus-host Disease (cGVHD))
1. Phase Ib study stage: Primary objective: To evaluate the efficacy and safety Secondary objectives: To evaluate the population pharmacokinetic characteristics 2.
- Trial name
- NCT06169722
- Testing
- TDI01 suspension
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Tide Pharmaceutical Co., Ltd
Idiopathic Pulmonary Fibrosis (IPF)
TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis
This is a Phase 1, 4-part, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1058 inhaled solution.
- Trial name
- NCT04589260
- Testing
- TD-1058
- Where
- United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Primary Hyperoxaluria Type 1
BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1)
The purpose of this study is to describe the natural history and progression of patients diagnosed with PH1, and to characterize the long-term real-world safety and effectiveness of lumasiran.
- Trial name
- BONAPH1DE (NCT04982393)
- Where
- 30 sites in United States, Belgium and 9 more
- Volunteers
- 207 people
- Sponsor
- Alnylam Pharmaceuticals
Cutaneous Melanoma, Uveal Melanoma, Ovarian Carcinoma or Other Advanced Solid Tumors
Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrades arginine. ADI has been formulated with polyethylene glycol, and has been used to treat patients that have cancers…
- Trial name
- NCT01665183
- Testing
- ADI-PEG 20
- Where
- 2 sites in United States, Taiwan
- Volunteers
- 8 people
- Sponsor
- Polaris Group
Primary Hyperoxaluria Type 1, End Stage Renal Disease
Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD
The aim of this study is to evaluate DCR-PHXC in participants with PH1 and severe renal impairment, with or without dialysis.
- Trial name
- PHYOX7 (NCT04580420)
- Testing
- DCR-PHXC
- Where
- 18 sites in United States, France and 8 more
- Volunteers
- 28 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Patients With PH1 Treated With Lumasiran in France
Retrospective and Prospective Follow-up of Patients With Primary Hyperoxaluria Type 1 Treated With Lumasiran in France.
Primary hyperoxaluria type 1 (PH1) is a rare genetic disease caused by mutation in the AGXT gene encoding the hepatic peroxisomal enzyme AGT.
- Trial name
- DAILY-LUMA (NCT06225882)
- Testing
- Oxaluria evolution.
- Where
- 7 sites in France
- Volunteers
- 100 people
- Sponsor
- Hospices Civils de Lyon
Hyperoxaluria, Primary
Follow-up of Pediatric Patients Affected by Primary Hyperoxaluria Type 1 (PH1) Treated With Lumasiran
The primary objective of the study is to confirm, in pediatric patients with type 1 hyperoxaluria treated with Lumasiran, the reduction in urinary oxalate excretion and plasma oxalate levels-already described at six months-on a…
- Trial name
- LUMA-KIDS (NCT07874074)
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Primary Hyperoxaluria Type 1, Primary Hyperoxaluria
A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in patients with Advanced Primary Hyperoxaluria Type 1 (PH1).
- Trial name
- ILLUMINATE-C (NCT04152200)
- Testing
- Lumasiran
- Where
- 14 sites in United States, Australia and 9 more
- Volunteers
- 21 people
- Sponsor
- Alnylam Pharmaceuticals
Pancreatic Cancer
Ph 1 Study of VS-4718, a FAK Inhibitor, in Combination With Nab-paclitaxel and Gemcitabine in Advanced Cancer Subjects
The purpose of this study is to evaluate increasing dose levels of VS-4718 administered in combination with gemcitabine and nab-paclitaxel in subjects with advanced cancer and to determine a recommended Phase 2 dose (RP2D) for…
- Trial name
- NCT02651727
- Testing
- Part B, Cohort 1- VS-4718, nab-paclitaxel, gemcitabine, Part B, Cohort 2- VS4718, nab-paclitaxel, gemcitabine, Part A- VS-4718, nab-paclitaxel, gemcitabine
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Verastem, Inc.
Meningococcal Infection, Group B
Phase 1 Safety and Immunogenicity of Meningococcal Vaccine
The purpose of this study is to determine whether a vaccine based on outer membrane vesicles (NOMV) from genetically detoxified group B meningococcus is safe and effective for use as a vaccine.
- Trial name
- HOPS (NCT00678652)
- Testing
- 10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine, 25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine, 50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Part A and B: Advanced Solid Malignancies, Part C: Malignant Mesothelioma
Ph1 to Assess Safety, Tolerability of Tremelimumab/ Tremelimumab+MEDI4736 in Japanese Solid Malignancies/ Mesothelioma
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab in combination with MEDI4736 in Japanese Patients…
- Trial name
- NCT02141347
- Testing
- Tremelimumab, MEDI4736
- Where
- 11 sites in Japan
- Volunteers
- 65 people
- Sponsor
- AstraZeneca
CML (Chronic Myelogenous Leukemia
IIT PH1 KDS-1001 in Patients With CML
This open label, non-randomized, prospective phase I study is designed to evaluate if the addition of natural killer cell therapy (KDS-1001) to tyrosine kinase inhibitors (TKIs) for chronic myeloid leukemia (CML) patients with…
- Trial name
- NCT04808115
- Testing
- KDS-1001
- Sponsor
- Duke University