Clinical trials: Intravenous Infusions
Abscess, Pain
Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children
Children can develop abscesses (a collection of pus under their skin) that require a physician to cut it open to let the pus drain out. This is a painful procedure.
- Trial name
- NCT01549002
- Testing
- Intranasal Fentanyl, Intravenous Morphine
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Columbia University
Autism Spectrum Disorder, ASD
Cord Blood Infusion for Children With Autism Spectrum Disorder
This is a single site, prospective, randomized, double-blind study of a single intravenous autologous or allogeneic, unrelated cord blood (CB) infusion in children ages 2-7 years with Autism Spectrum Disorder (ASD).
- Conditions
- Autism Spectrum Disorder, ASD, Autism, PDD
- Trial name
- Duke ACT (NCT02847182)
- Testing
- Cord Blood Infusion
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Joanne Kurtzberg, MD
Crohn's Disease
Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease
This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in…
- Trial name
- NCT02038920
- Testing
- Vedolizumab
- Where
- 56 sites in Japan
- Volunteers
- 157 people
- Sponsor
- Takeda
Myeloid Leukemia, Chronic, Myeloid Leukemia, Chronic, Accelerated-Phase
Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)
This will be an open label, multi-center study of up to 77 patients with CML in chronic, accelerated or blast phase who have developed resistance to or have failed previous treatment with Gleevec (imatinib mesylate).
- Conditions
- Myeloid Leukemia, Chronic, Myeloid Leukemia, Chronic, Accelerated-Phase, Blast Phase, Myeloid Leukemia, Chronic, Chronic-Phase
- Trial name
- NCT00114959
- Testing
- Homoharringtonine, Imatinib Mesylate
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- ChemGenex Pharmaceuticals
Peripheral T Cell Lymphoma, Pediatric Hodgkin Lymphoma
Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma"
The purpose of this survey is to examine the safety of adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with…
- Trial name
- NCT04213209
- Testing
- Brentuximab Vedotin (Genetical Recombination)
- Where
- Japan
- Volunteers
- 95 people
- Sponsor
- Takeda
Ulcerative Colitis
Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis
The purpose of this study is to evaluate efficacy, safety and pharmacokinetics of the vedolizumab (MLN0002) induction and maintenance therapy in Japanese participants with moderate or severe ulcerative colitis (UC).
- Trial name
- NCT02039505
- Testing
- Vedolizumab
- Where
- 59 sites in Japan
- Volunteers
- 292 people
- Sponsor
- Takeda
Gastric Cancer
Safety and Efficacy of Trastuzumab BS
To confirm the safety and efficacy of this drug under the actual use
- Trial name
- NCT04181333
- Testing
- TRASTUZUMAB BS
- Where
- Japan
- Volunteers
- 8 people
- Sponsor
- Pfizer
Ulcerative Colitis
Special Drug-Use Surveillance Study on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]
The purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in ulcerative colitis (UC) patients in the routine clinical setting.
- Trial name
- NCT03824561
- Testing
- Vedolizumab
- Where
- Japan
- Volunteers
- 1,110 people
- Sponsor
- Takeda
Transthoracic Echocardiography, Suspected or Known Structural or Functional Cardiac Abnormality
Study to Determine Safety and Dosage of OPTISON in Pediatric Participants
Study to determine the safety and appropriate dosage of OPTISON in pediatric participants since OPTISON has been tested in adult participants only during the clinical development
- Trial name
- NCT03740997
- Testing
- Optison
- Where
- 8 sites in United States
- Volunteers
- 39 people
- Sponsor
- GE Healthcare
Pneumonia, Bacterial, Community-Acquired Infections
A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia
The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with pneumonia.
- Conditions
- Pneumonia, Bacterial, Community-Acquired Infections, Nosocomial Infection, Pneumonia, Ventilator-Associated
- Trial name
- NCT01110421
- Testing
- Cefepime, Doripenem, Amoxicillin/clavulanate potassium
- Where
- 25 sites in United States, Argentina and 8 more
- Volunteers
- 7 people
- Sponsor
- Janssen Research & Development, LLC
Hemophilia
A Proof-of-concept Study to Reduce Treatment Burden in Haemophilia Participants Receiving Factor VIII and Factor IX Infusions
The main aim is to describe how the treatment burden and challenges of participants, relatives, and doctors during regular Factor VIII and Factor IX infusions to treat hemophilia evolve using a virtual-reality (VR) based…
- Trial name
- NCT05437211
- Testing
- Virtual-reality (VR) Based Solution
- Where
- 6 sites in France
- Volunteers
- 24 people
- Sponsor
- Takeda
Spinal Muscular Atrophy Type I
Single-Dose Gene Replacement Therapy Using for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies
This is a Phase 3, open-label, single-arm, single-dose, trial of onasemnogene abeparvovec-xioi (gene replacement therapy) in participants with spinal muscular atrophy (SMA) Type 1 and who are genetically defined by a biallelic…
- Trial name
- NCT03837184
- Testing
- Onasemnogene Abeparvovec-xioi
- Where
- 4 sites in Japan, South Korea and 1 more
- Volunteers
- 2 people
- Sponsor
- Novartis Gene Therapies
Primary Immunodeficiency Disease
High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)
This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main…
- Trial name
- NGAM-05 (NCT01313507)
- Testing
- NewGam
- Where
- 6 sites in United States
- Volunteers
- 21 people
- Sponsor
- Octapharma
Primary Immunodeficiency Disease
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
- Trial name
- NCT02810444
- Testing
- IgG Next Generation (BT595)
- Where
- 19 sites in United States, Germany and 3 more
- Volunteers
- 81 people
- Sponsor
- Biotest
SMA
Single-Dose Gene Replacement Therapy Clinical Trial for Participants With Spinal Muscular Atrophy Type 1
Phase 3, open-label, single-arm, single-dose, trial of onasemnogene abeparvovec-xioi (gene replacement therapy) in patients with spinal muscular atrophy (SMA) Type 1 who meet enrollment criteria and are genetically defined by a…
- Trial name
- STRIVE-EU (NCT03461289)
- Testing
- Onasemnogene Abeparvovec-xioi
- Where
- 10 sites in Belgium, France and 2 more
- Volunteers
- 33 people
- Sponsor
- Novartis Gene Therapies
Bronchopulmonary Dysplasia
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
- Trial name
- NCT03857841
- Testing
- UNEX-42, Phosphate-buffered saline
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- United Therapeutics
T-cell Type Acute Leukemia-Precursor, T-lymphoblastic Lymphoma/Leukaemia
Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
Primary Objective: To evaluate the efficacy of isatuximab. Secondary Objectives: To evaluate the safety profile of isatuximab. To evaluate the duration of response (DOR).
- Trial name
- ISLAY (NCT02999633)
- Testing
- Isatuximab SAR650984, dexamethasone, acetaminophen
- Where
- 17 sites in United States, Finland and 5 more
- Volunteers
- 14 people
- Sponsor
- Sanofi
Hereditary Angioedema (HAE)
Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of…
- Trial name
- NCT02052141
- Testing
- CINRYZE 500, CINRYZE 1000
- Where
- 8 sites in United States, Germany and 3 more
- Volunteers
- 12 people
- Sponsor
- Shire
Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory
First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological…
- Conditions
- Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory, Myelodysplastic Syndromes, Blastic Plasmacytoid Dendritic Cell Neoplasia
- Trial name
- NCT05086315
- Testing
- SAR443579
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 101 people
- Sponsor
- Sanofi
Congenital Hyperinsulinism
CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism
This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a continuous subcutaneous infusion to prevent…
- Trial name
- NCT02937558
- Testing
- Glucagon
- Where
- 5 sites in United States
- Volunteers
- 5 people
- Sponsor
- Xeris Pharmaceuticals