90 matching studies

Sponsor Condition of Interest
Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine...
National Institute of Allergy and Infectious Diseases (NIAID) HIV Infections
This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW). expand

This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).

Type: Interventional

Start Date: Dec 2016

open study

Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects...
Pfizer Dermatitis, Atopic
B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying Phase 3 study. The efficacy and safety of two dosage strengths of Abrocitinib,... expand

B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying Phase 3 study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country

Type: Interventional

Start Date: Mar 2018

open study

Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic...
Merck Sharp & Dohme Corp. Prostatic Neoplasms
The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly(ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone... expand

The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly(ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: 1. Overall Survival (OS) and 2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR)

Type: Interventional

Start Date: May 2019

open study

Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With...
Merck Sharp & Dohme Corp. Prostatic Neoplasms
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve,... expand

The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.

Type: Interventional

Start Date: Jul 2019

open study

A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse...
AbbVie Hypogonadism Cardiovascular Diseases
This is a blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with increased risk for cardiovascular (CV) disease. expand

This is a blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with increased risk for cardiovascular (CV) disease.

Type: Interventional

Start Date: May 2018

open study

A Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis
AbbVie Dermatitis
The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adult and adolescent subjects. expand

The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adult and adolescent subjects.

Type: Interventional

Start Date: Dec 2018

open study

An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer...
Janssen Research & Development, LLC Prostatic Neoplasms
The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies. expand

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.

Type: Interventional

Start Date: Aug 2016

open study

Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or...
Southwest Oncology Group Deleterious BRCA1 Gene Mutation Deleterious BRCA2 Gene Mutation Loss of Heterozygosity Lung Non-Small Cell Squamous Carcinoma Recurrent Large Cell Lung Carcinoma
This phase II Lung-MAP trial studies how well rucaparib works in treating patients with genomic loss of heterozygosity (LOH) high and/or deleterious BRCA1/2 mutation stage IV non-small cell lung cancer or that has come back. Rucaparib may stop the growth of tumor cells by blocking... expand

This phase II Lung-MAP trial studies how well rucaparib works in treating patients with genomic loss of heterozygosity (LOH) high and/or deleterious BRCA1/2 mutation stage IV non-small cell lung cancer or that has come back. Rucaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Type: Interventional

Start Date: Jan 2019

open study

Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
Intercept Pharmaceuticals Liver Cirrhosis, Biliary
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational... expand

Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC patients.

Type: Interventional

Start Date: Dec 2014

open study

Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
Elorac, Inc. Mycosis Fungoides Lymphoma, T-Cell, Cutaneous Sézary Syndrome
This multi-center, double-blind, vehicle-controlled, randomized crossover design study will evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS) Forms of... expand

This multi-center, double-blind, vehicle-controlled, randomized crossover design study will evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS) Forms of Cutaneous T-cell Lymphoma (CTCL). This study will also determine if there is systemic absorption of the drug in a subset of subjects and if so, describe the range and mean plasma levels reached after two weeks of three time daily (TID) dosing. Funding Source - FDA OOPD

Type: Interventional

Start Date: Jan 2017

open study

AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults...
Tobira Therapeutics, Inc. Nonalcoholic Steatohepatitis
The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH. expand

The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH.

Type: Interventional

Start Date: Apr 2017

open study

Assessing Physician and Hemophilia A Patient Reasons and Expectations for Switching Treatment to Kovaltry...
Bayer Hemophilia A
This US study aims to assess hemophilia A patient characteristics and reasons for switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A patients who have switched from an existing therapy to Kovaltry or... expand

This US study aims to assess hemophilia A patient characteristics and reasons for switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A patients who have switched from an existing therapy to Kovaltry or Jivi. In doing so, real world evidence will be obtained from both patient and physician perspectives offering key insights for effective therapeutic management of patients with hemophilia A and to more fully understand what drives patient switching from a patient perspective and a physician perspective.

Type: Observational

Start Date: Aug 2018

open study

Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer...
Alliance for Clinical Trials in Oncology Node Positive HER2 Negative Breast Cancer
This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) negative breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug... expand

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) negative breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

Type: Interventional

Start Date: Dec 2016

open study

Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Standard of Care Therapies for Treatment...
NovoCure Ltd. Nonsmall Cell Lung Cancer
The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of TTFields, using the NovoTTF-100L System, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment.The... expand

The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of TTFields, using the NovoTTF-100L System, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Type: Interventional

Start Date: Dec 2016

open study

BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
Boehringer Ingelheim Colitis, Ulcerative
This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are - to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous... expand

This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are - to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II) - to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III) - To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.

Type: Interventional

Start Date: Mar 2018

open study

An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis...
Eli Lilly and Company Ulcerative Colitis
The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC. expand

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

Type: Interventional

Start Date: Jun 2018

open study

A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence...
Bristol-Myers Squibb Hepatocellular Carcinoma Liver Cancer
This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence expand

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

Type: Interventional

Start Date: Dec 2017

open study

Study Evaluating PK/PD and Safety of Betrixaban in Pediatric Patients
Portola Pharmaceuticals VTE Prophylaxis
A Phase 1, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of Betrixaban in Pediatric Patients expand

A Phase 1, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of Betrixaban in Pediatric Patients

Type: Interventional

Start Date: Jul 2018

open study

Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
Pharmacyclics LLC. Treatment Naive Follicular Lymphoma
The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma. expand

The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma.

Type: Interventional

Start Date: Jan 2017

open study

EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
Boehringer Ingelheim Heart Failure
The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with preserved ejection fraction expand

The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with preserved ejection fraction

Type: Interventional

Start Date: Mar 2017

open study

A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing...
Seattle Genetics, Inc. Hodgkin Lymphoma Peripheral T Cell Lymphoma Anaplastic Large Cell Lymphoma
This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment. expand

This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.

Type: Interventional

Start Date: Oct 2019

open study

Prostate Specific Membrane Antigen (PSMA)-Based PET Imaging of High Risk Prostate Cancer
National Cancer Institute (NCI) Prostate Cancer
Background: People with prostate cancer usually have their cancer imaged with a CT scan and bone scan. They then have their prostate gland removed. Researchers want to test a scan that might predict if prostate cancer will return after this surgery. Objective:... expand

Background: People with prostate cancer usually have their cancer imaged with a CT scan and bone scan. They then have their prostate gland removed. Researchers want to test a scan that might predict if prostate cancer will return after this surgery. Objective: To test if a PET/CT scan before the prostate gland is removed can predict if prostate cancer will return. Also, to test if this approach is better or worse than the usual approach for prostate cancer. Eligibility: Men ages 18 and older with prostate cancer that appears to be contained within the prostate but is at risk of having spread Design: Participants will be screened with: - Medical history - Blood tests - CT and MRI scans: Participants will lie in a machine. The machine will take pictures of the body. - Bone scan Participants will have a radiotracer injected into a vein. They will have a PET/CT scan of their whole body 60 90 minutes later. During the scan, they will lie on their back and stay still. Within 60 days after the scan, participants will have surgery. This will remove the prostate gland and lymph nodes around it. Some tissue will be used for genetic testing. If the PET/CT scan suggests the cancer has spread, participants may need to have another biopsy within 60 days after the scan. After surgery, participants will have follow-up visits for 5 years. They will have 5 visits the first year and 2 the second. Then they will have visits once a year. If participants cancer returns, they will have repeat PET/CT scans.

Type: Interventional

Start Date: Dec 2019

open study

Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
CareDx Kidney Transplant Rejection
This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to... expand

This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment. Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®.

Type: Observational

Start Date: Jan 2018

open study

177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer
Advanced Accelerator Applications Prostatic Neoplasm
This Phase 1/2 study is intended to investigate the safety, tolerability, and radiation dosimetry of 177Lu-PSMA-R2 and further assess preliminary efficacy data in patients with metastatic castration-resistant prostate cancer (mCRPC). The Phase 1 portion of the study will determine... expand

This Phase 1/2 study is intended to investigate the safety, tolerability, and radiation dosimetry of 177Lu-PSMA-R2 and further assess preliminary efficacy data in patients with metastatic castration-resistant prostate cancer (mCRPC). The Phase 1 portion of the study will determine the recommended dose of 177Lu-PSMA-R2 for radio-ligand therapy (RLT) of mCRPC, and the Phase 2 portion will expand into approximately 60 patients documenting the preliminary activity (anti-tumor response) of repeated treatments administered, continuing safety assessments and collecting QoL data.

Type: Interventional

Start Date: May 2018

open study

Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
Tulane University School of Public Health and Tropical Medicine Diabetes PreDiabetes Metabolic Disease Hyperglycemia Diet Modification
The proposed randomized controlled trial will test the effect of a low-carbohydrate diet on hemoglobin A1c among individuals with elevated hemoglobin A1c that are within the range of prediabetes or diabetes. Results may provide evidence about the role of carbohydrate restriction... expand

The proposed randomized controlled trial will test the effect of a low-carbohydrate diet on hemoglobin A1c among individuals with elevated hemoglobin A1c that are within the range of prediabetes or diabetes. Results may provide evidence about the role of carbohydrate restriction in individuals with or at high risk of type 2 diabetes.

Type: Interventional

Start Date: Sep 2018

open study