Clinical trials: Patient Safety
Hereditary Angioedema (HAE)
Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)
The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE.
- Trial name
- NCT00262080
- Testing
- ecallantide, Phosphate Buffer Saline (PBS),
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- Shire
Narcolepsy
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy.
- Trial name
- SUVN-G3031 (NCT04072380)
- Testing
- SUVN-G3031
- Where
- 41 sites in United States, Canada
- Volunteers
- 190 people
- Sponsor
- Suven Life Sciences Limited
Lung Diseases, Interstitial
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study.
- Trial name
- NCT05321082
- Testing
- BI 1015550
- Where
- 400 sites in United States, Argentina and 43 more
- Volunteers
- 1,178 people
- Sponsor
- Boehringer Ingelheim
Severe Sepsis, Septic Shock
A Study to Assess Safety,and Tolerability of 2 Doses of AZD9773 (CytoFab™) in Japanese With Severe Sepsis/Septic Shock
The two co-primary objectives of this study are to assess in Japanese patients with severe sepsis and/or septic shock: 1) the safety and tolerability of two different doses of intravenous AZD9773 and 2) the PK of AZD9773.
- Trial name
- NCT01144624
- Testing
- AZD9773
- Where
- 7 sites in Japan
- Volunteers
- 20 people
- Sponsor
- AstraZeneca
Lymphocytic Leukemia, Chronic
A Study of Rituximab (MabThera) in Combination With Chemotherapy in Participants With CD20-Positive B-Cell Chronic Lymphocytic Leukemia
This observational study will evaluate the safety and efficacy of rituximab in combination with chemotherapy in first- and second-line treatment of participants with cluster of differentiation 20 (CD20)-positive B-cell chronic…
- Trial name
- CaLLypso (NCT01609023)
- Testing
- Rituximab
- Where
- 9 sites in Greece
- Volunteers
- 67 people
- Sponsor
- Hoffmann-La Roche
Diabetic Foot Ulcer
CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers
The study is aimed at comparing debridement either with CO2 laser or traditional surgery in patients with infected diabetic foot ulcers. The principal endpoint is bacterial load immediately after treatment.
- Trial name
- DULCIS (NCT02677779)
- Testing
- CO2 laser, traditional surgery
- Volunteers
- 20 people
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
Chronic Obstructive Pulmonary Disease
Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered Using an eFlow Nebulizer in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The study assessed the safety and ability of an orally inhaled medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered using an eFlow nebulizer in 42 patients with Chronic…
- Trial name
- NCT02948582
- Testing
- Glycopyrrolate Inhalation Solution12.5μg, Glycopyrrolate Inhalation Solution 50μg, Glycopyrrolate Inhalation Solution 100μg
- Volunteers
- 42 people
- Sponsor
- Sunovion Respiratory Development Inc.
Juvenile Idiopathic Arthritis
A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)
This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.
- Trial name
- JIGSAW 117 (NCT01904279)
- Testing
- Tocilizumab
- Where
- 35 sites in United States, Argentina and 10 more
- Volunteers
- 52 people
- Sponsor
- Hoffmann-La Roche
Hormone Sensitive Prostate Cancer, Prostate Cancer
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.
- Conditions
- Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate
- Trial name
- NCT02319837
- Testing
- Enzalutamide, Leuprolide Open Label
- Where
- 255 sites in United States, Australia and 15 more
- Volunteers
- 1,068 people
- Sponsor
- Pfizer
Lupus Erythematosus, Systemic
A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
This current Phase 3 study will evaluate the efficacy and safety of administration of subcutaneous (sc) IPP-201101 in patients with active SLE.
- Trial name
- LUPUZOR (NCT02504645)
- Testing
- IPP-201101, Standard of Care
- Where
- 30 sites in United States, Czechia and 6 more
- Volunteers
- 202 people
- Sponsor
- ImmuPharma
Epilepsy, Generalized Tonic-clonic Seizures
A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years with uncontrolled Generalized Tonic-Clonic…
- Trial name
- NCT01292837
- Testing
- Levetiracetam
- Where
- 26 sites in Japan
- Volunteers
- 13 people
- Sponsor
- UCB Japan Co. Ltd.
Myelodysplastic Syndrome
Vosaroxin for Intermediate 2 or High-risk MDS After Failure With Hypomethylating Agent-based Therapy
Study WCMC IST/VOS/MDS evaluates the safety and tolerability of escalating doses of vosaroxin in adult patients with pathologically confirmed Myelodysplastic Syndrome, or MDS, (< 20% blasts in bone marrow, peripheral blood, or…
- Trial name
- NCT01980056
- Testing
- Vosaroxin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Weill Medical College of Cornell University
Chronic Obstructive Pulmonary Disease
A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.
- Trial name
- INTENSITY (NCT00900731)
- Testing
- Indacaterol 150 μg, Tiotropium 18 μg
- Where
- 212 sites in United States, Austria and 20 more
- Volunteers
- 1,598 people
- Sponsor
- Novartis Pharmaceuticals
Autologous Stem Cell Transplantation
AMD3100 (Plerixafor) With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed Hematopoietic Stem Cell (HSC) Collection/Attempts
This study evaluates the safety, efficacy, and pharmacokinetics (PK) of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous…
- Trial name
- NCT00396331
- Testing
- G-CSF plus plerixafor
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Genzyme, a Sanofi Company
Advanced Prostate Cancer, Lower Urinary Tract Symptoms
Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
The purpose of the study is to determine the influence of GnRH (gonadotropin releasing hormone) analogue - Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine) administration on intensity of lower urinary tract symptoms…
- Trial name
- LEMON (NCT01078545)
- Testing
- Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)
- Where
- 143 sites in Poland, Ukraine
- Volunteers
- 729 people
- Sponsor
- Abbott
Nakajo-Nishimura Syndrome, Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature Syndrome
A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGS
The main purpose of this study is to evaluate the efficacy and safety of baricitinib in adult and pediatric Japanese participants with Nakajo-Nishimura Syndrome/chronic atypical neutrophilic dermatosis with lipodystrophy and…
- Conditions
- Nakajo-Nishimura Syndrome, Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature Syndrome, STING-Associated Vasculopathy With Onset in Infancy, Aicardi Goutieres Syndrome
- Trial name
- NCT04517253
- Testing
- Baricitinib
- Where
- 5 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Eli Lilly and Company
Rhegmatogenous Retinal Detachment - Macula Off
A Study to Evaluate the Safety and Tolerability of ONL1204 in Patients With Macula-off, Rhegmatogenous Retinal Detachment
The purpose of this study is to evaluate the safety and tolerability of ONL1204 in participants with Macula-off, Rhegmatogenous Retinal Detachment (RRD).
- Trial name
- NCT03780972
- Testing
- ONL1204, Intravitreal Injection, Collection of ocular fluids
- Where
- 4 sites in Australia
- Volunteers
- 14 people
- Sponsor
- ONL Therapeutics
Chronic Hepatitis D Infection With Hepatitis B
A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D
This is a multicenter, open-label, randomized clinical trial to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination with Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients…
- Trial name
- NCT03546621
- Testing
- Myrcludex B, Myrcludex-B, Tenofovir
- Where
- 15 sites in Germany, Russia
- Volunteers
- 120 people
- Sponsor
- Hepatera Ltd.
Primary Axillary Hyperhidrosis
A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of…
- Trial name
- NCT03785587
- Testing
- Sofpironium Bromide Gel, 15%
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Botanix Pharmaceuticals
Atopic Dermatitis
Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
This was a parallel treatment, Phase 2, double-blind, 2-arm, placebo-controlled study with 2 staggered cohorts (2 arms in each cohort) to evaluate the efficacy and safety of rilzabrutinib in adult participants (aged at least 18…
- Trial name
- NCT05018806
- Testing
- Rilzabrutinib
- Where
- 31 sites in United States, Canada and 5 more
- Volunteers
- 124 people
- Sponsor
- Sanofi
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