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Found 46 clinical trials
Study Investigating PK PD Efficacy Safety and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

This is a multicenter, randomized, parallel arm, double-blind study with a total duration up to 82 weeks. Approximately 522 postmenopausal patients with osteoporosis will be randomized at the beginning of Treatment Period 1 (Baseline to Week 52) to receive 2 doses of either GP2411 or EU-authorized Prolia. At the beginning …

  • 441 views
  • 16 Sep, 2020
  • 52 locations
Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)

This study is aimed to comprehensively establish the bio-similarity/bioequivalence in EPIAO and EPREX in terms of 52-week comparisons in efficacy, safety and immunogenicity. The targeted population is anaemia patients with end-stage chronic renal disease who previously received epoetin treatment and on haemodialysis.

dialysis
erythropoietin
eprex
chronic kidney disease
biosimilar
  • 96 views
  • 29 Oct, 2020
  • 19 locations
Clinical Trial Comparing a Biosimilar Eptacog Alfa With Novoseven in Patients With Hemophilia With Inhibitors

biosimilar eptacog alfa (activated) with Novoseven in 48 patients, adult and children (>12 years), not bleeding, with hemophilia A or B with inhibitors. Patients will be randomized to receive either a

  • 18 views
  • 15 Jan, 2021
  • 13 locations
Study Comparing the Pharmacokinetic of Biosimilar Eptacog Alfa With Novoseven in Patients With Congenital Factor VII Deficiency

The purpose of this multicentre, randomized, double blinded, single dose, two-way cross-over study, is to compare the pharmacokinetics (PK) of biosimilar eptacog alfa (activated) with Novoseven

  • 12 views
  • 15 Jan, 2021
  • 2 locations
A Double-blind Study to Compare the Efficacy Safety and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara in Patients With Moderate-to-Severe Plaque Psoriasis

This is a randomized, double-blind, multicenter study to evaluate the efficacy, safety, and immunogenicity of FYB202 compared to Stelara in patients with Moderate-to-Severe Plaque Psoriasis.

  • 0 views
  • 26 Oct, 2020
  • 2 locations
A Phase 1 Study to Assess the Immunogenicity of QL0605 Compared to US Neulasta in Healthy Subjects

Pharmaceutical Co., Ltd. proposed biosimilar QL0605 compared to innovator product, US-Neulasta) in healthy, adult, human subjects.

  • 0 views
  • 11 Dec, 2020
  • 2 locations
A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1)

combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50.

trastuzumab
estrogen
progesterone receptor
progesterone
primary tumor
  • 89 views
  • 09 Sep, 2020
  • 15 locations
Extension Study of MYL-1701P-3001 for Safety and Efficacy

This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 study.

  • 0 views
  • 26 Dec, 2020
  • 1 location
PK Bioequivalence Single-dose Safety Tolerability Study in Healthy Male Volunteers to Compare CBT124 & Avastin(EU&US)

This study aims to investigate the bioequivalence of new formulation of bevacizumab called CBT124 and safety when compared to two already marketed formulations, one approved in US and other in EU of Avastin(Registered Trademark). Adult healthy male aged 18 to 50 years (both inclusive) can participate in this trial. Participants …

  • 0 views
  • 08 Nov, 2020
  • 1 location
Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis in Patients With nAMD

The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).

age-related macular degeneration
vegf
angiography
ranibizumab
corrected visual acuity
  • 249 views
  • 08 Jul, 2020
  • 109 locations