Clinical trials: sponsored by Janssen Research & Development, LLC
Respiratory Syncytial Virus Infections
A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection
The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the clinical diagnosis of asthma and the frequency of wheezing in infants and children with respiratory syncytial virus (RSV) infection who were…
- Trial name
- NCT03332459
- Testing
- Lumicitabine
- Where
- 4 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
Pre-approval Access for Janssen's COVID Vaccine VAC31518 for Treating Physician Use
The purpose of this Pre-approval access (PAA) program is to provide VAC31518 (Ad26.CoV2.S) vaccine for the prevention of coronavirus disease-2019 (COVID-19) infection.
- Trial name
- NCT04817657
- Testing
- Ad26.COV2.S
- Sponsor
- Janssen Research & Development, LLC
H7N9 Subtype of Influenza A Virus
Pre-Approval Access to Pimodivir for the Treatment of Patients With H7N9 Influenza A Infection
The purpose of this program is to provide pre-approval access to pimodivir for the treatment of a patient(s) with H7N9 influenza A infection.
- Trial name
- NCT03834376
- Testing
- Pimodivir
- Sponsor
- Janssen Research & Development, LLC
Pre-Approval Access for Administration of Daratumumab Subcutaneously (SC) in Participants Who Are Unable to Receive Intravenous (IV) Daratumumab
The purpose of this pre-approval access (PAA) program is to provide treatment to participants with serious/life-threatening diseases or conditions.
- Trial name
- NCT04264884
- Testing
- Daratumumab
- Sponsor
- Janssen Research & Development, LLC
Respiratory Syncytial Viruses
A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus
The purpose of this study is to determine in hospitalized infants and children who are infected with respiratory syncytial virus (RSV) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity…
- Trial name
- NCT03333317
- Testing
- Lumicitabine
- Where
- 29 sites in United States, Belgium and 4 more
- Volunteers
- 7 people
- Sponsor
- Janssen Research & Development, LLC
Pulmonary Multi-drug Resistant Tuberculosis
A Prospective Patient Registry of Patients Exposed to Bedaquiline
The purpose of this study is to describe the medical indication and utilization of expert medical consultation among participants treated with bedaquiline (BDQ), BDQ susceptibility based on minimum inhibitory concentrations…
- Trial name
- NCT02274389
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Janssen Research & Development, LLC
Acute Myeloid Leukemia
A Study of Decitabine (DACOGEN) in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia
The purpose of this study is to examine the safety and efficacy of decitabine in sequential administration with cytarabine in children with relapsed or refractory acute myeloid leukemia (AML).
- Trial name
- NCT01853228
- Testing
- Phase1 and Phase 2: decitabine, Phase 1: cytarabine, Phase 2: cytarabine
- Where
- 17 sites in Belgium, Denmark and 5 more
- Volunteers
- 17 people
- Sponsor
- Janssen Research & Development, LLC
HIV-1
Study to Assess the Acceptability/Swallowability of DRV-Containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets
The primary purpose of this study is to assess the acceptability of swallowing the darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets…
- Trial name
- NCT02993237
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis
A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients
The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.
- Trial name
- NCT00207688
- Testing
- Infliximab 5 mg/kg, Infliximab 10 mg/kg
- Where
- 102 sites in United States, Argentina and 13 more
- Volunteers
- 505 people
- Sponsor
- Janssen Research & Development, LLC
Spondylitis, Ankylosing
An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement
The purpose of this observational (a study that follows participants forward in time) study is to compare the functional improvement of hip joint using Harris hip score between 2 treatment groups (infliximab and conventional…
- Trial name
- RECOVERY (NCT02293681)
- Testing
- Infliximab, NSAIDs, DMARDs
- Where
- 6 sites in China
- Volunteers
- 76 people
- Sponsor
- Janssen Research & Development, LLC
Autism Spectrum Disorder
Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
The purpose of this study is to assess the usability of the Janssen Autism Knowledge Engine (JAKE) as a system to monitor clinical outcomes in autism spectrum disorder (ASD) (severe abnormalities in the development of many basic…
- Trial name
- Mentis (NCT02299700)
- Testing
- No Intervention
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Janssen Research & Development, LLC
Sarcoma
A Study to Provide Access to Trabectedin in Participants With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care Treatment
The purpose of this study is to facilitate access to trabectedin for eligible previously treated patients with soft tissue sarcoma (STS), who cannot be expected to benefit from currently available therapeutic options but who may…
- Trial name
- NCT00210665
- Testing
- Trabectedin
- Where
- 36 sites in United States, Canada and 1 more
- Sponsor
- Janssen Research & Development, LLC
Diabetes Mellitus, Type 2
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the pharmacokinetics (blood levels) and pharmacodynamics (the action or effects a drug has on the body) of canagliflozin in children and adolescents with type 2 diabetes mellitus aged 10…
- Trial name
- NCT02000700
- Testing
- Canagliflozin 100 mg, Canagliflozin 50 mg, Canagliflozin 300 mg
- Where
- 17 sites in United States, Brazil
- Volunteers
- 17 people
- Sponsor
- Janssen Research & Development, LLC
Attention Deficit Disorder With Hyperactivity
Concerta (Methylphenidate) -To-Generic Switch Study
The primary purpose of this study is to identify whether, after adjustment for confounders via stratification on a propensity score and adjustment for calendar year, the combined endpoint consisting of #1 to #4 (1.
- Trial name
- NCT02730572
- Testing
- Concerta, Concerta AG formulation, Concerta EG formulation
- Volunteers
- 1,464 people
- Sponsor
- Janssen Research & Development, LLC
Schizophrenia, Schizophrenic Disorders
Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.
The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.
- Conditions
- Schizophrenia, Schizophrenic Disorders, Psychotic Disorders, Dementia Praecox
- Trial name
- NCT00488319
- Testing
- Paliperidone ER
- Where
- 53 sites in United States, Belgium and 9 more
- Volunteers
- 400 people
- Sponsor
- Janssen Research & Development, LLC
Autism Spectrum Disorder
Study to Assess the Janssen Autism Knowledge Engine in Participants With Autism Spectrum Disorder and in a Normally Developing Cohort
The purpose of this study is to evaluate the utility of and to clinically validate the Autism Behavior Inventory (ABI) in measuring clinical symptoms of Autism Spectrum Disorder (ASD) compared with other gold standard measures.
- Trial name
- NCT02668991
- Where
- 9 sites in United States
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Helminth Infections
A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with placebo in pediatric participants with Helminth infections.
- Trial name
- NCT02034162
- Testing
- Mebendazole
- Where
- 3 sites in Ethiopia, Rwanda
- Volunteers
- 295 people
- Sponsor
- Janssen Research & Development, LLC
Respiratory Syncytial Virus
A Study in Belgian Children Hospitalized With Respiratory Syncytial Virus Related Acute Respiratory Infections
The purpose of the study is to assess viral kinetics and clinical symptoms kinetics in pediatric patients hospitalized with Respiratory Syncytial Virus (RSV) confirmed lower respiratory tract infection (LRTI).
- Trial name
- NCT02133092
- Testing
- No intervention
- Where
- 4 sites in Belgium
- Volunteers
- 62 people
- Sponsor
- Janssen Research & Development, LLC
Advanced Liposarcoma or Leiomyosarcoma
A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma
The purpose of this study is to evaluate whether overall survival for the trabectedin group is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or leiomyosarcoma).
- Trial name
- NCT01343277
- Testing
- Trabectedin, Dacarbazine
- Where
- 88 sites in United States, Australia and 2 more
- Volunteers
- 579 people
- Sponsor
- Janssen Research & Development, LLC
Juvenile Idiopathic Arthritis
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to…
- Trial name
- NCT01230827
- Testing
- CNTO 148 (Golimumab), Methotrexate
- Where
- 35 sites in United States, Austria and 10 more
- Volunteers
- 173 people
- Sponsor
- Janssen Research & Development, LLC