Search clinical trials for: EU-approved Neulasta

Total 741 results

Pfizer
Hospira, now a wholly owned subsidiary of Pfizer

Completed

A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants

Neutropenia

Australia
Fresenius Kabi SwissBioSim GmbH

Completed

MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis

Rheumatoid Arthritis

Hungary, Serbia, Georgia, Russian Federation, Slovakia, Czechia, Bulgaria, Moldova, Republic of, Poland
Celltrion

Recruiting

A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

Healthy Subjects

Korea, Republic of
Pfizer

Completed

A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers

Healthy Volunteers

United States
Fresenius Kabi SwissBioSim GmbH

Completed

Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456

Healthy

New Zealand
Celltrion

Recruiting

To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis

Moderate to Severe Chronic Plaque Psoriasis

Estonia
Celltrion

Completed

Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects

Healthy Subjects

New Zealand
Bio-Thera Solutions

Active, not recruiting

Assessment on Efficacy and Safety of BAT2306 and Cosentyx® in Plaque Psoriasis Patients

Plaque Psoriasis

China
Fresenius Kabi SwissBioSim GmbH

Completed

MSB11022 in Healthy Subjects

Healthy Subjects
Mylan Inc.
Mylan GmbH

Completed

Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta

Healthy Volunteers

Netherlands
Celltrion

Not yet recruiting

A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis
Celltrion

Completed

To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects

Healthy

Korea, Republic of
Celltrion

Completed

A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects

Healthy Male Subjects

Australia
Coherus Biosciences, Inc.

Completed

Assessing the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta®

Immunity, Humoral

United States
Gan and Lee Pharmaceuticals, USA

Completed

PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males

Diabetes Mellitus

Germany
University Hospital Southampton NHS Foundation...
Imperial College London; Public Health England

Completed

Safety of Nasal Influenza Immunisation in Egg Allergic Children (SNIFFLE)

Egg Hypersensitivity

United Kingdom
Vrije Universiteit Brussel
University of British Columbia; University of Coimbra; Amsterdam UMC, location... and other collaborators

Not yet recruiting

International Study to Evaluate a Navigation Program for Older People With Cancer and Their Family Caregivers (EU NAVIGATE Study) (EU NAVIGATE)

Cancer (Active Cancer, Meaning Not Being Cancer Free), of Any Stage and Involving Any Treatment/Care Regimen; i.e. Curative, Life-extending, or Palliative
Celltrion

Completed

To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria (omalizumab)

Chronic Spontaneous Urticaria

Poland
Sandoz
Sandoz GmbH

Completed

Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim (PROTECT2)

Breast Cancer | Chemotherapy-induced Neutropenia

Spain, United States, Argentina, Chile, India, Malaysia, Puerto Rico, Russian Federation
mAbxience Research S.L.

Completed

A Pharmacokinetic Study Comparing MB02 And EU Avastin® In Healthy Male Volunteers

Healthy Volunteers | Male | Japanese

Japan
University of North Carolina, Chapel Hill

Completed

A Study of Inhalation of 20,000 EU CCRE and Mucociliary Clearance (MCC) in Otherwise Healthy Individuals Who Are Current Cigarette Smokers (IRB 09-0259)

Healthy | Cigarette Smoking

United States
Cinfa Biotech

Completed

Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects

Healthy Volunteers

Germany
Amgen

Completed

A Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis After Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer

Breast Cancer | Non-Hodgkin's Lymphoma | Ovarian Cancer | Lung Cancer | Neutropenia
Omega Ophthalmics

Completed

Clinical Investigation of Omega Refractive Capsule Model V With Use of an FDA Approved IOL (ORCV)

Cataract

Costa Rica
Ruhr University of Bochum

Completed

Tachosil for the Prevention of Symptomatic Lymph Cysts

Cervical Cancer | Endometrial Cancer

Austria, Germany
Kashiv BioSciences, LLC

Completed

To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects

Healthy

India
Celltrion

Completed

To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects

Healthy

Australia
Celltrion

Completed

To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin

Healthy

Korea, Republic of
Adocia

Completed

A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus

Type 1 Diabetes

Germany
Intas Pharmaceuticals, Ltd.
Lambda Therapeutic Research Ltd.

Completed

Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.

Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers

India
Intas Pharmaceuticals, Ltd.
Lambda Therapeutic Research Ltd.

Completed

Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.

Healthy Volunteers | Immunogenicity

India
Cinfa Biotech

Completed

Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects

Clinical Pharmacology

Germany
University Hospital, Clermont-Ferrand
Amgen

Unknown

Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5) (MEG-5)

Solid Malignancies

France
Amgen

Completed

Neulasta® in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) During Chemotherapy

Non-Small Cell Lung Cancer
Dartmouth-Hitchcock Medical Center

Terminated

Feasibility and Cost Analysis of PBSC Mobilization Using Pegfilgrastim in Hematologic Malignancies

Hematologic Malignancies

United States
Hospital Universitario Dr. Jose E. Gonzalez

Completed

Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilrastim for Neutrophil Recovery After Autotransplant

Lymphoma | Myeloma Multiple

Mexico
Fresenius Kabi SwissBioSim GmbH

Completed

Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

Healthy

Australia
Seoul National University Hospital
Green Cross Corporation

Completed

Pharmacokinetics and Pharmacodynamics of a Novel Pegylated Recombinant Human Granulocyte-Colony Stimulating Factor (GCPGC)

Healthy

Korea, Republic of
ISU Abxis Co., Ltd.

Completed

A Phase I Study to Compare Abcertin and EU-sourced Cerezyme® in Healthy Volunteers

Gaucher Disease

Australia
University Hospital Inselspital, Berne

Completed

The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus

Diabetes Mellitus, Type 1 | Exercise

Switzerland
Coherus Biosciences, Inc.

Completed

Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 With Neulasta

Healthy

United States
Coherus Biosciences, Inc.

Completed

Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim)

Bioequivalence

United States
Fresenius Kabi SwissBioSim GmbH

Completed

Safety and Immunogenicity of MSB11455 in Healthy Participants

Healthy

New Zealand
Hospira, now a wholly owned subsidiary of Pfizer

Completed

Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating Pegfilgrastim Hospira Compared to Neulasta (Amgen) in Healthy Volunteers

Healthy

United Kingdom
Huntridge Family Clinic

Unknown

What Happens in Vegas: PEP to PrEP Opportunities

Exposure to Human Immunodeficiency Virus (Event)

United States
Omega Ophthalmics

Active, not recruiting

Clinical Investigation of Omega Refractive Capsule, Model VI (ORCVI)

Cataract

Costa Rica
mAbxience Research S.L.

Completed

Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers

Healthy Volunteers

Germany
EVIVE Biotechnology

Completed

Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Breast Cancer | Neutropenia

United States
Qilu Pharmaceutical Co., Ltd.

Unknown

A Phase 1 Study to Assess the Immunogenicity of QL0605 Compared to US Neulasta in Healthy Subjects

Healthy

Germany, United Kingdom
Teva Branded Pharmaceutical Products R&D, Inc.

Completed

A comparatiVe Study on Efficacy and Safety of Lipegfilgrastim in Comparison to Pegfilgrastim in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia (AVOID)

Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia

Germany, Italy, Spain

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