Clinical trials: PFS
Healthy Volunteers
A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants
The purpose of this study is to compare the PK of single dose of Vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
- Trial name
- NCT03961308
- Testing
- Vedolizumab SC
- Where
- 2 sites in United States
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- Takeda
Macular Edema
A Study in Patients With Neovascular Age Related Macular Degeneration or Macular Edema Secondary To Retinal Vein Occlusion to Evaluate Usability of the Ranibizumab (Lucentis®) Prefilled Syringe (PFS)
This is a multicenter study designed to evaluate usability of ranibizumab PFS in patients with neovascular age related macular degeneration or macular edema secondary to retinal vein occlusion.
- Trial name
- NCT02698566
- Testing
- Ranibizumab
- Where
- 4 sites in United States
- Volunteers
- 35 people
- Sponsor
- Genentech, Inc.
Age-Related Macular Degeneration, Branch Retinal Vein Occlusion with Macular Edema
Ocular Safety and Usability Study for FYB201 PFS
The objective of the study is to assess the ocular safety of the FYB201 pre-filled syringe in terms of preparation and administration by Retina Specialists in the clinical setting.
- Conditions
- Age-Related Macular Degeneration, Branch Retinal Vein Occlusion with Macular Edema, Central Retinal Vein Occlusion with Macular Edema
- Trial name
- NCT06708624
- Testing
- FYB201 0.5 mg (0.05 mL of 10 mg/mL)
- Where
- 4 sites in United States
- Volunteers
- 31 people
- Sponsor
- Formycon AG
CLL / SLL, CLL (Chronic Lymphocytic Leukemia)
ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL
This is a Phase 3, randomized, open-label, multicenter study comparing rocbrutinib (LP-168) versus pirtobrutinib in adult participants with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma…
- Conditions
- CLL / SLL, CLL (Chronic Lymphocytic Leukemia), CLL, Refractory, CLL, Relapsed
- Trial name
- NCT07342478
- Testing
- Rocbrutinib, Pirtobrutinib
- Where
- 6 sites in United States
- Volunteers
- 306 people
- Sponsor
- Newave Pharmaceutical Inc
Carcinoma, Non-Small-Cell Lung
Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation
This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II…
- Trial name
- PACIFIC-4 (NCT03833154)
- Testing
- Durvalumab, (Osimertinib cohort, single-arm, open-label separate cohort)
- Where
- 209 sites in United States, Australia and 18 more
- Volunteers
- 724 people
- Sponsor
- AstraZeneca
Healthy Volunteer
A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers
This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers.
- Trial name
- NCT01418989
- Testing
- tocilizumab [RoActemra/Actemra] Syringe, tocilizumab [RoActemra/Actemra] auto-injector
- Where
- 2 sites in France
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Age-Related Macular Degeneration, Branch Retinal Vein Occlusion With Macular Edema
A Study to Evaluate the Usability of the SB11 PFS in Trial Participants With Wet AMD, Macular Oedema Secondary to RVO, or mCNV
This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar).
- Conditions
- Age-Related Macular Degeneration, Branch Retinal Vein Occlusion With Macular Edema, Central Retinal Vein Occlusion With Macular Edema, Myopic Choroidal Neovascularization
- Trial name
- NCT07550504
- Testing
- SB11 PFS
- Where
- 2 sites in Poland
- Volunteers
- 30 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Neovascular Age-related Macular Degeneration (nAMD)
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe
This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.
- Trial name
- NCT05161806
- Testing
- SOK583A1 (40 mg/mL), Prefilled Syringe (PFS)
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Sandoz
Healthy Volunteers
A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants
The purpose of this study is to compare PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
- Trial name
- NCT03961295
- Testing
- Vedolizumab SC
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy, Multiple Sclerosis
Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers
The purpose of this study is to characterize the pharmacokinetic (PK) profile, safety, and tolerability of peginterferon beta-1a (BIIB017) delivered by the single-use autoinjector or prefilled syringe (PFS) in healthy volunteers…
- Trial name
- NCT01610310
- Testing
- BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS), BIIB017 (peginterferon beta-1a) Autoinjector
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Biogen
First or Second Line HER2-negative Breast Cancer, Metastatic Disease Without Bone Metastasis
Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients
This study will evaluate zoledronic acid's anti-cancer effects and Circulating Tumor Cell (CTCs) measurements in patients with HER2-negative metastatic breast cancer without bone metastasis.
- Trial name
- MACS1295 (NCT01129336)
- Testing
- Zoledronic acid, Standard Therapy
- Where
- 33 sites in United States
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
Comparison the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers
The purpose of this study was to compare the safety and pharmacokinetic characteristics of DWP422 25 mg with those of ENBREL 25MG PFS INJ. after subcutaneous injection in healthy male volunteers.
- Trial name
- NCT01635686
- Testing
- DWP422 25mg, ENBREL 25MG PFS INJ.
- Where
- South Korea
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Multiple Myeloma
Observational Registry Study of Chinese Patients Treated With Revlimid (Lenalidomide)
The primary objective of this study is to document efficacy and safety data in a real-world setting of Chinese multiple myeloma patients who have received at least one prior therapy treated with REVLIMID (lenalidomide).
- Trial name
- NCT01947309
- Testing
- Revlimid (lenalidomide)
- Where
- 17 sites in China
- Volunteers
- 176 people
- Sponsor
- Celgene
Neovascular Age-related Macular Degeneration, Macular Edema
A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO
This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar).
- Conditions
- Neovascular Age-related Macular Degeneration, Macular Edema, Retinal Vein Occlusion
- Trial name
- NCT06176963
- Testing
- SB11 PFS
- Where
- 3 sites in Poland
- Volunteers
- 34 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Non-Small-Cell Lung Carcinoma NSCLC
Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the…
- Trial name
- MYSTIC (NCT02453282)
- Testing
- MEDI4736 (Durvalumab), MEDI4736 (Durvalumab)+Tremelimumab, Paclitaxel + Carboplatin
- Where
- 196 sites in United States, Australia and 15 more
- Volunteers
- 1,118 people
- Sponsor
- AstraZeneca
Anaplastic Lymphoma Kinase-positive, Carcinoma Non-small-cell Lung
A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors
The primary purpose of this study is to determine the differences in PFS for participants who have been receiving brigatinib as ALK inhibitor therapy for ALK+NSCLC compared to those participants receiving alectinib, ceritinib…
- Trial name
- NCT03546894
- Testing
- Brigatinib, Alectinib, Ceritinib
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- Takeda
Anemia of Chronic Kidney Disease
Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease
Phase III, multicenter, randomized, open, controlled clinical trial. A study designed as phase III, in 120 patients with chronic renal failure in the pre-dialysis stage, evaluate efficacy and safety of Hemax PFS® (PFS: prefilled…
- Trial name
- NCT04036253
- Testing
- Erythropoietin alfa
- Where
- 11 sites in Argentina, Paraguay
- Volunteers
- 43 people
- Sponsor
- Bio Sidus SA
Age-Related Macular Degeneration, Branch Retinal Vein Occlusion with Macular Edema
Ocular Safety and Usability Study for FYB203 PFS
The objective of the study is to assess the ocular safety of the FYB203 pre-filled syringe in terms of preparation and administration by Retina Specialists in the clinical setting.
- Conditions
- Age-Related Macular Degeneration, Branch Retinal Vein Occlusion with Macular Edema, Central Retinal Vein Occlusion with Macular Edema, Diabetic Macular Edema
- Trial name
- NCT06708637
- Testing
- FYB203 2 mg (0.05 mL of 40 mg/mL)
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Formycon AG
Chorioretinal Vascular Disease
Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease
This is a single-arm, open label, multicenter clinical study to evaluate the handling and safety of AVT06 pre-filled syringe (PFS) in subjects with chorioretinal vascular disease followed by an optional extension phase of AVT06…
- Trial name
- ALVOEYE-D (NCT05986786)
- Testing
- Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule
- Where
- Georgia
- Volunteers
- 35 people
- Sponsor
- Alvotech Swiss AG
Healthy Volunteers
A Study of Marstacimab to Compare Prefilled Pen (PFP) Device to Prefilled Syringe (PFS) Device
The goal in this study is to show that there are not significant differences in biologic activity of the study drug when administered using either the prefilled pen and prefilled syringe.
- Trial name
- NCT04832139
- Testing
- Marstacimab PFP, Marstacimab PFS
- Where
- Belgium
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Pfizer