Clinical trials: Patient Safety
Acinetobacter Baumannii-calcoaceticus Complex, Hospital-acquired Bacterial Pneumonia
Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
This is a 2-part study, with Part A being the randomized, controlled portion of the study in patients with ABC hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or bacteremia.
- Conditions
- Acinetobacter Baumannii-calcoaceticus Complex, Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, Bacteremia
- Trial name
- ATTACK (NCT03894046)
- Testing
- Sulbactam, Durlobactam, Colistin
- Where
- 90 sites in United States, Belarus and 15 more
- Volunteers
- 207 people
- Sponsor
- Entasis Therapeutics
Carcinoma, Hepatocellular
A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma
This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate neoadjuvant immunotherapy combinations in participants with resectable HCC.
- Trial name
- NCT05908786
- Testing
- Atezolizumab, Bevacizumab, Tiragolumab
- Where
- 14 sites in United States, Austria and 4 more
- Volunteers
- 62 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer With Intracranial Metastases
Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases
This phase II trial will combine two agents, cabazitaxel and lapatinib, to treat patients with metastatic breast cancer (MBC) which has metastasized to the brain.
- Trial name
- NCT01934894
- Testing
- cabazitaxel, lapatinib
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- SCRI Development Innovations, LLC
Chronic Obstructive Pulmonary Disease (COPD)
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan.
- Trial name
- NCT00876694
- Testing
- Indacaterol 300 µg, Salmeterol 50 µg
- Where
- 37 sites in Japan
- Volunteers
- 186 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Disease, Chronic Obstructive
Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease II
The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.
- Trial name
- NCT00796653
- Testing
- Olodaterol (BI 1744), Formoterol
- Where
- 98 sites in Argentina, Brazil and 18 more
- Volunteers
- 937 people
- Sponsor
- Boehringer Ingelheim
Epilepsy
Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU
This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased seizure activity.
- Trial name
- NCT01999777
- Testing
- USL261
- Where
- 51 sites in United States, Australia and 6 more
- Volunteers
- 62 people
- Sponsor
- UCB Biopharma S.P.R.L.
Primary Immunodeficiency Diseases (PID)
A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants
The main aim of the study is to check side effect from the study treatment with TAK-771 in long term. Participants can have taken part in the previous study TAK-771-3004 (NCT05150340).
- Trial name
- NCT05513586
- Testing
- TAK-771
- Where
- 9 sites in Japan
- Volunteers
- 15 people
- Sponsor
- Takeda
Alopecia Areata
European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata
The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, severe alopecia areata.
- Trial name
- NCT05041803
- Testing
- CTP-543
- Where
- 39 sites in France, Germany and 3 more
- Volunteers
- 407 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Alzheimer Disease
Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD.
- Trial name
- NCT03443973
- Testing
- Gantenerumab
- Where
- 155 sites in United States, Argentina and 17 more
- Volunteers
- 975 people
- Sponsor
- Hoffmann-La Roche
Plaque Psoriasis
Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis
The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function.
- Trial name
- NCT02340169
- Testing
- Topicort® (desoximetasone) Topical Spray, 0.25%
- Where
- United States
- Volunteers
- 129 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Celiac Disease
PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).
- Trial name
- PROACTIVE (NCT04424927)
- Testing
- PRV-015
- Where
- 38 sites in United States, Canada and 2 more
- Volunteers
- 388 people
- Sponsor
- Provention Bio, a Sanofi Company
Lymphocytic Leukemia, Chronic
A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status
This multi-center, randomized study compared the efficacy and safety of MabThera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in participants with previously untreated B-cell…
- Trial name
- NCT01283386
- Testing
- Chlorambucil, Cyclophosphamide, Fludarabine
- Where
- 8 sites in Russia
- Volunteers
- 26 people
- Sponsor
- Hoffmann-La Roche
Friedreich's Ataxia
A First in Human Study of RT001 in Patients With Friedreich's Ataxia
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of RT001 in patients with Friedreich's ataxia.
- Trial name
- NCT02445794
- Testing
- Low dose cohort, High dose cohort
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Biojiva LLC
Lung Cancer
Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC
This is an open-label, single-arm, multicenter, exploratory Phase II study sponsored by Astrazeneca Investment (China) Co., LTD.
- Trial name
- MINOVA (NCT05215951)
- Testing
- osimertinib
- Where
- 6 sites in China
- Volunteers
- 4 people
- Sponsor
- AstraZeneca
Psoriasis, Arthritic
A Study of Ixekizumab in Participants With Active Psoriatic Arthritis
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.
- Trial name
- SPIRIT-P1 (NCT01695239)
- Testing
- Ixekizumab, Adalimumab
- Where
- 116 sites in United States, Belgium and 13 more
- Volunteers
- 417 people
- Sponsor
- Eli Lilly and Company
Erythropoietic Protoporphyria
Multicentre Phase III Erythropoietic Protoporphyria Study
This was a phase III, multicentre, randomised, double-blind, placebo-controlled study, to evaluate the safety and efficacy of subcutaneous bioresorbable afamelanotide implants in patients with Erythropoietic Protoporphyria (EPP).
- Trial name
- NCT04053270
- Testing
- Afamelanotide
- Volunteers
- 100 people
- Sponsor
- Clinuvel Pharmaceuticals Limited
Postsurgical Pain
Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)
In the pilot (Part A) of this study, multiple doses of CA-008 (vocacapsaicin) were evaluated for safety, tolerability, and PK. Doses were then selected for the expanded part (Part B) of the study, where CA-008 was compared to…
- Trial name
- NCT04203537
- Testing
- CA-008
- Where
- 4 sites in United States
- Volunteers
- 193 people
- Sponsor
- Concentric Analgesics
Phenylketonuria
A Study to Evaluate Subcutaneously Administered rAvPAL-PEG in Patients With Phenylketonuria for 24 Weeks
The primary objective of the study is to evaluate the effect of dosing regimens of multiple subcutaneous (SC) doses of rAvPAL-PEG to induce an early and sustained Phe reduction while decreasing the frequency and severity of…
- Trial name
- NCT01560286
- Testing
- BMN 165 (rAvPAL-PEG)
- Where
- 6 sites in United States
- Volunteers
- 24 people
- Sponsor
- BioMarin Pharmaceutical
Classical Hodgkin Lymphoma, Recurrent Hodgkin Lymphoma
Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
This phase II trial evaluates how effective 560 mg of ibrutinib taken by mouth daily is in the treatment of classical Hodgkin lymphoma which recurs or does not respond to initial treatment.
- Conditions
- Classical Hodgkin Lymphoma, Recurrent Hodgkin Lymphoma, Refractory Hodgkin Lymphoma
- Trial name
- NCT02824029
- Testing
- Ibrutinib, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis
Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)
The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in patients with Tenosynovial Giant Cell Tumor (TGCT).
- Conditions
- Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath
- Trial name
- NCT05804045
- Testing
- Pimicotinib(ABSK021)
- Where
- 40 sites in United States, Canada and 5 more
- Volunteers
- 94 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
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