Clinical trials: pMN
Chemotherapy-Induced Neutropenia
Safety and Efficacy Trial of Recombinant Human Granulocyte Colony Stimulating Factor (GCSF)
A Phase III Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen In Patients on…
- Trial name
- NCT00776165
- Testing
- Recombinant Human GCSF (Shantha Biotechnics Limited), Neupogen
- Where
- 7 sites in India
- Volunteers
- 126 people
- Sponsor
- Shantha Biotechnics Limited
Crohn Disease
Open-label Trial of Leukine in Active Crohn's Disease
The purpose of this study is to establish a safety profile sargramostim administered in 8 week cycles to adult patients with active Crohn's disease.
- Trial name
- NCT00206700
- Testing
- Sargramostim (Leukine)
- Where
- 167 sites in United States, Argentina and 8 more
- Volunteers
- 378 people
- Sponsor
- Genzyme, a Sanofi Company
Neoplasms (no Otherwise Specified)
A Clinical Trial of Patients With Solid Tumours Receiving Granulocyte Colony Stimulating Factor as Primary Prophylaxis for Chemotherapy-induced Neutropenia, in a Docetaxel Based Regimen
Primary Objective: To evaluate the incidence and severity of neutropenia in patients being treated for solid tumours with a Taxotere® based regimen when Granocyte® 34 is being used as a primary prophylaxis for…
- Trial name
- Grano-Tax (NCT01107756)
- Testing
- LENOGRASTIM (GRANOGYTE 34)
- Where
- 25 sites in South Africa
- Volunteers
- 403 people
- Sponsor
- Sanofi
Postmenopausal Symptoms
A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopausal Women
The purpose of this study is to assess the efficacy and safety of repeated administration of G-CSF for the treatment of hot flashes and vasomotor symptoms in women with naturally-occurring or surgically induced menopause.
- Trial name
- NCT03640754
- Testing
- G-CSF
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- MenoGeniX, Inc.
HIV Infections, Cytopenias
A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility
To assess the safety and efficacy of subcutaneously administered sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the neutrophil count in HIV-infected adults who have…
- Trial name
- NCT00002006
- Testing
- Zidovudine, Sargramostim
- Where
- United States
- Sponsor
- Sandoz
Febrile Neutropenia, Cancer
Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for…
- Conditions
- Febrile Neutropenia, Cancer, Breast Cancer, Ovarian Cancer
- Trial name
- Monitor-GCSF (NCT01459653)
- Where
- 117 sites in Austria, Belgium and 10 more
- Volunteers
- 1,496 people
- Sponsor
- Sandoz
Solid Tumor, Gastrointestinal Cancer
OH2 Oncolytic Viral Therapy in Solid Tumors
This phase I/II study evaluates the safety and efficacy of OH2 as single agent or in combination with HX008, an anti-PD-1 antibody, in patients with malignant solid tumors (gastrointestinal cancers, head and neck cancers, soft…
- Trial name
- NCT03866525
- Testing
- OH2 injection, with or without irinotecan or HX008
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Binhui Biopharmaceutical Co., Ltd.
HIV Infections, Cytopenias
A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia
To evaluate the safety of repeated courses of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to patients with HIV infection and leukopenia.
- Trial name
- NCT00002007
- Testing
- Zidovudine, Sargramostim
- Where
- United States
- Sponsor
- Sandoz
Cytomegalovirus Retinitis, HIV Infections
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute…
- Trial name
- NCT00002070
- Testing
- Sargramostim, Ganciclovir
- Where
- 14 sites in United States
- Sponsor
- Schering-Plough
Healthy Adult Subjects
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects
TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine whether TJ003234 is safe and tolerated when…
- Trial name
- NCT03794180
- Testing
- TJ003234
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- I-Mab Biopharma US Limited
Soft Tissue Sarcoma, Sarcoma
A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma
The purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be managed with filgrastim (a Granulocyte-Colony Stimulation…
- Conditions
- Soft Tissue Sarcoma, Sarcoma, Neoplasms, Connective and Soft Tissue, Neoplasms by Histologic Type
- Trial name
- NCT00102609
- Testing
- Doxorubicin, Trabectedin, Dexamethasone
- Volunteers
- 41 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Primary Membranous Nephropathy
Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)
The primary objective of this study is to evaluate the efficacy of ALXN1920 compared with placebo in participants with PMN who are at a high risk for disease progression using 24-hour urine protein creatinine ratio (UPCR).
- Trial name
- AUTUMN (NCT07157787)
- Testing
- ALXN1920
- Where
- 40 sites in United States, Argentina and 8 more
- Volunteers
- 30 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Small Cell Lung Cancer, Soft Tissue Sarcoma
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells.
- Conditions
- Small Cell Lung Cancer, Soft Tissue Sarcoma, Triple-negative Breast Cancer, Ovarian Cancer
- Trial name
- EDO-S101 (NCT03345485)
- Testing
- Tinostamustine 60mg/m2 over 30min, Tinostamustine 80mg/m2 over 30min, Tinostamustine 100mg/m2 over 30min
- Where
- 13 sites in United States, Canada and 3 more
- Volunteers
- 71 people
- Sponsor
- Mundipharma Research Limited
Neutropenia, Breast Cancer
Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up to 4 cycles of Epirubicin and Cyclophosphamide.
- Trial name
- NCT02527746
- Testing
- F-627, EC regimen
- Volunteers
- 18 people
- Sponsor
- EVIVE Biotechnology
Diabetic Nephropathies, Primary Focal Segmental Glomerulosclerosis
Study of WAL0921 in Patients With Glomerular Kidney Diseases
This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and…
- Conditions
- Diabetic Nephropathies, Primary Focal Segmental Glomerulosclerosis, Minimal Change Disease, Primary Immunoglobulin A Nephropathy
- Trial name
- NCT06466135
- Testing
- WAL0921
- Where
- 50 sites in United States, Australia and 5 more
- Volunteers
- 96 people
- Sponsor
- Walden Biosciences
Glomerulonephritis, Membranous
A Phase 3 Study of Inebilizumab in Participants With Primary Membranous Nephropathy
The primary objective of this study to evaluate the efficacy of inebilizumab on primary membranous nephropathy (PMN) disease activity as measured by complete remission in participants with PMN.
- Trial name
- MOMENT (NCT07851220)
- Testing
- Inebilizumab, Tacrolimus
- Where
- 4 sites in United States
- Volunteers
- 159 people
- Sponsor
- Amgen
NSCLC, Neutropenia
A Study of Pegylated rhG-CSF as Support to Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy Receiving Chemotherapy
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.
- Conditions
- NSCLC, Neutropenia, Febrile Neutropenia
- Trial name
- NCT01560195
- Testing
- Pegylated rhG-CSF: 100µg/kg, Pegylated rhG-CSF: 6mg
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hodgkin's Disease
AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease
Participants with Hodgkin's Disease (HD) who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this…
- Trial name
- NCT00396201
- Testing
- G-CSF Plus Plerixafor
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Genzyme, a Sanofi Company
Ulcerative Colitis
CESA 5.10 Investigation to Compare the Efficacy and Safety of the Adacolumn® Apheresis Device in Patients With Active Ulcerative Colitis
The purpose of this study is to compare the safety and efficacy of 5 Adacolumn® treatments over 5 weeks to 10 treatments (two Adacolumn® apheresis treatments during the first 2 weeks, followed by 6 weeks with one Adacolumn®…
- Trial name
- NCT00366925
- Testing
- Adacolumn®
- Where
- Germany
- Volunteers
- 174 people
- Sponsor
- Otsuka Frankfurt Research Institute GmbH
Arthritis, Rheumatoid
Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects
This exploratory study aims to assess exposure of healthy subjects to systemic challenge with either LPS or GM-CSF. This will be done by measuring inflammatory mediators and cellular activation markers both in circulation and in…
- Trial name
- NCT03306589
- Testing
- Cantharidin, Lipopolysaccharide, Granulocyte-Macrophage Colony-Stimulating Factor
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline