Clinical trials: Subcutaneous Injection
Asthma
Long Term Special Drug Use Investigation of Mepolizumab
This study is a special drug use investigation program of NUCALA (a brand name for Mepolizumab) administered subcutaneously (SC).
- Trial name
- NCT03028480
- Testing
- NUCALA Injection
- Volunteers
- 1,061 people
- Sponsor
- GlaxoSmithKline
Juvenile Idiopathic Arthritis
An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)
Primary Objective: To describe the pharmacokinetic (PK) profile of sarilumab in participants aged 2-17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for adequate…
- Trial name
- SKYPP (NCT02776735)
- Testing
- Sarilumab
- Where
- 30 sites in United States, Argentina and 13 more
- Volunteers
- 102 people
- Sponsor
- Sanofi
Primary Mitochondrial Myopathy
A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension
This is a multicenter phase 3 randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the safety and efficacy of daily subcutaneous injections of elamipretide in subjects with primary mitochondrial…
- Trial name
- MMPOWER-3 (NCT03323749)
- Testing
- elamipretide, elamipretide open label treatment
- Where
- 27 sites in United States, Canada and 5 more
- Volunteers
- 218 people
- Sponsor
- Stealth BioTherapeutics Inc.
Schizophrenia
Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia
The purpose of the study is to evaluate the efficacy, safety, and tolerability of different dose regimens of TV-46000 administered subcutaneously (SC) as compared to placebo during maintenance treatment in adult and adolescent…
- Trial name
- RISE (NCT03503318)
- Testing
- TV-46000
- Where
- 81 sites in United States, Bulgaria
- Volunteers
- 544 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Opioid-use Disorder
Evaluation of Long-term Buprenorphine Plasma Exposure
The study objective is to characterise the long-term plasma exposure to buprenorphine after stopping SUBLOCADE treatment. There are no interventions planned.
- Trial name
- NCT03752528
- Testing
- Blood sample collection, Urine sample collection
- Where
- 11 sites in United States
- Volunteers
- 53 people
- Sponsor
- Indivior Inc.
Prostate Cancer
Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer
The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in: achieving castrate levels of testosterone (< 1.735…
- Trial name
- NCT01656161
- Testing
- Triptorelin embonate 22.5 mg
- Where
- 10 sites in South Africa
- Volunteers
- 120 people
- Sponsor
- Debiopharm International SA
Behcet's Disease
Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation)
This investigation was conducted to obtain the following information regarding the use of Adalimumab (Humira®) 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Intestinal Behcet's Disease. 1.
- Trial name
- NCT01960790
- Volunteers
- 473 people
- Sponsor
- AbbVie
Arthritis, Juvenile Rheumatoid
Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis
This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints with this drug: Unknown adverse drug reactions (especially important adverse…
- Trial name
- NCT01412021
- Volunteers
- 375 people
- Sponsor
- AbbVie
Hypoparathyroidism, Hypocalcemia
Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism
This randomized crossover study will evaluate the safety, efficacy, and pharmacodynamics of synthetic human PTH 1-34 (PTH) delivered by an insulin pump (omnipod) compared with twice- daily subcutaneous injections.
- Conditions
- Hypoparathyroidism, Hypocalcemia, Autoimmune Polyendocrine Syndrome Type 1, Autosomal Dominant Hypocalcemia Type 1 (ADH1)
- Trial name
- NCT00743782
- Testing
- Synthetic Human Parathyroid Hormone 1-34 pump
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
Hereditary Angioedema (HAE)
Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
The purpose of this study is to assess the efficacy and safety of subcutaneous administration of a liquid formulation of C1 esterase inhibitor for the prevention of angioedema attacks in adolescent and adult subjects with…
- Trial name
- NCT02584959
- Testing
- C1 esterase inhibitor [human] liquid
- Where
- 27 sites in United States, Canada and 5 more
- Volunteers
- 75 people
- Sponsor
- Shire
Ulcerative Colitis
Special Investigation in Patients With Ulcerative Colitis
This investigation will be conducted to obtain the following information regarding the use of Humira 40 mg Syringe 0.8 mL for Subcutaneous Injection in patients with Ulcerative Colitis. 1.
- Trial name
- NCT01947816
- Volunteers
- 1,621 people
- Sponsor
- AbbVie
Primary Mitochondrial Disease
Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study
This randomized, double-blind, placebo-controlled, crossover study screened 32 subjects with primary mitochondrial myopathy (PMM) to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of subcutaneous…
- Trial name
- MMPOWER-2 (NCT02805790)
- Testing
- Elamipretide
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Stealth BioTherapeutics Inc.
Primary Hyperoxaluria Type 1 (PH1), Primary Hyperoxaluria Type 2 (PH2)
A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2
The purpose of this study is to evaluate the efficacy and safety of DCR-PHXC in Children and Adults with Primary Hyperoxaluria Type 1 (PH1) and Primary Hyperoxaluria Type 2 (PH2)
- Conditions
- Primary Hyperoxaluria Type 1 (PH1), Primary Hyperoxaluria Type 2 (PH2), Kidney Diseases, Urologic Diseases
- Trial name
- PHYOX2 (NCT03847909)
- Testing
- DCR-PHXC, Sterile Normal Saline (0.9% NaCl)
- Where
- 28 sites in United States, Australia and 13 more
- Volunteers
- 35 people
- Sponsor
- Novo Nordisk A/S
Chronic Lymphocytic Leukemia
Campath-1H Plus Rituximab for CD52- and CD20- Positive Refractory or Relapsed Chronic Lymphoid Disorders
The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can shrink or slow the growth of the disease in patients with chronic lymphoid disorders that have either not responded or whose disease has…
- Trial name
- NCT00071396
- Testing
- Campath-1H, Rituximab
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- M.D. Anderson Cancer Center
Systemic Lupus Erythematosus
BENLYSTA® Special Drug Use Investigation
The objective of this study is to collect and assess the information about long-term safety and effectiveness of Benlysta for intravenous injection and Benlysta for subcutaneous injection (hereinafter referred to as "Benlysta")…
- Trial name
- NCT03370263
- Testing
- Benlysta
- Where
- Japan
- Volunteers
- 1,514 people
- Sponsor
- GlaxoSmithKline
Hemophilia A, Hemophilia B
Study of the Efficacy and Safety PF-06741086 in Adult and Teenage Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B
Treatment with PF-06741086 is anticipated to demonstrate a clinically relevant advantage and/or a major contribution to patient care in comparison to current methods of treatment for hemophilia A or B because it works differently…
- Trial name
- NCT03938792
- Testing
- PF-06741086
- Where
- 62 sites in United States, Bulgaria and 18 more
- Volunteers
- 188 people
- Sponsor
- Pfizer
Idiopathic Short Stature
A Phase 3 Study to Evaluate the Safety and Efficacy of Saizen® in Children With Idiopathic Short Stature (ISS)
This is an open-label, multi-center, randomized, two-arm parallel, no-treatment group controlled (only for the first 6 months), Phase 3 study in children with ISS.
- Trial name
- NCT01746862
- Testing
- Saizen®
- Where
- South Korea
- Volunteers
- 90 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Schizophrenia
A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia
The primary objective of the study is to evaluate the long-term safety and tolerability of TV-46000. The primary safety and tolerability endpoint is the frequency of all adverse events, including serious adverse events.
- Trial name
- SHINE (NCT03893825)
- Testing
- TV-46000
- Where
- 90 sites in United States, Bulgaria and 3 more
- Volunteers
- 336 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Rheumatoid Arthritis
Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis
To clarify the following matters: Unknown adverse reactions (especially clinically significant adverse reactions) Incidence and conditions of occurrence of adverse reactions in the clinical setting Factors that may affect the…
- Trial name
- NCT01076959
- Where
- 1,723 sites in Japan
- Volunteers
- 7,972 people
- Sponsor
- Abbott
Phenylketonuria
Safety, Tolerability, and Efficacy Study of rAvPAL-PEG Administered Daily in Subjects With Phenylketonuria (PKU)
The purpose of this study is to evaluate the effect of daily administration of rAvPAL-PEG on the reduction of blood Phe concentrations in subjects with PKU.
- Trial name
- NCT01212744
- Testing
- rAvPAL-PEG
- Where
- 9 sites in United States
- Volunteers
- 16 people
- Sponsor
- BioMarin Pharmaceutical