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SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
Hemophilia A With Inhibitor
Hemophilia B With Inhibitor
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with
Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term
prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding
event (BE), or who are not on p1 expand
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on prophylactic treatment who may need to control a BE. Type: Interventional Start Date: Jun 2021 |
Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Ne1
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
This phase III trial compares the effect of usual treatment of chemotherapy and steroids
and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab.
Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability
of cancer cells to grow and spread. The i1 expand
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care. Type: Interventional Start Date: Jan 2021 |
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Childr1
Coronavirus Infection (COVID-19)
Pulmonary Arterial Hypertension
Urinary Tract Infections in Children
Hypertension
Pain
The study investigators are interested in learning more about how drugs, that are given
to children by their health care provider, act in the bodies of children and young adults
in hopes to find the most safe and effective dose for children. The primary objective of
this study is to evaluate the PK1 expand
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider. Type: Observational Start Date: Mar 2020 |
Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in P1
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
In this observational study researcher want to learn more about the effectiveness of drug
VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine
use in patients with TRK fusion cancer which is locally advanced or spread from the place
where it started to other plac1 expand
In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months. Type: Observational Start Date: Apr 2020 |
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Meta1
Metastatic Breast Cancer
This is an umbrella study evaluating the efficacy and safety of multiple treatment
combinations in participants with metastatic or inoperable locally advanced breast
cancer.
The study will be performed in two stages. During Stage 1, four cohorts will be enrolled
in parallel in this study:
Cohort1 expand
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study: Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naive cohort). Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort). Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment. Type: Interventional Start Date: Mar 2018 |
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
Cystic Fibrosis
CFTR Gene Mutation
ARCT-032-02 is a Phase 2, open-label, multicenter, multiple-ascending dose study of
ARCT-032 in adults with CF who are not eligible for CFTR modulator therapy or are not
taking CFTR modulators due to drug intolerance, poor response, or lack of access to
modulators. expand
ARCT-032-02 is a Phase 2, open-label, multicenter, multiple-ascending dose study of ARCT-032 in adults with CF who are not eligible for CFTR modulator therapy or are not taking CFTR modulators due to drug intolerance, poor response, or lack of access to modulators. Type: Interventional Start Date: Dec 2024 |
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Part1
Focal Onset Seizure
Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and
several other countries around the world for the treatment of Partial-Onset (focal)
seizures in adult subjects (≥18 years of age). In the US it is approved for use as
monotherapy, however, there is little clinic1 expand
Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy. Type: Interventional Start Date: Oct 2024 |
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
The goal of this study is to learn if GS-1427 is effective in treating participants with
moderate to severe ulcerative colitis. The study will compare participants in different
treatment groups treated with GS-1427 with participants treated with placebo.
The primary objective of this study is to a1 expand
The goal of this study is to learn if GS-1427 is effective in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo. The primary objective of this study is to assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12. Type: Interventional Start Date: Mar 2024 |
Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Bilia1
Primary Biliary Cholangitis
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in
subjects with PBC. expand
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC. Type: Interventional Start Date: Feb 2024 |
A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejec1
Heart Failure
Heart Failure With Reduced Ejection Fraction
Cardiovascular Diseases
Heart Diseases
The purpose of this study is to evaluate the safety and effectiveness of tovinontrine
compared to placebo to lower NT-proBNP in patients with chronic heart failure with
reduced ejection fraction. expand
The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with reduced ejection fraction. Type: Interventional Start Date: Feb 2024 |
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cance1
Breast Cancer, Early Breast Cancer
This is a Phase III open-label study to assess if camizestrant improves outcomes compared
to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer
with intermediate-high or high risk for disease recurrence who completed definitive
locoregional therapy (with or without1 expand
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years. Type: Interventional Start Date: Oct 2023 |
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism
Deep Venous Thrombosis
Post-Thrombotic Syndrome
This study is a prospective, multicenter, randomized controlled trial of an
interventional strategy using the ClotTriever System to achieve and maintain vessel
patency (ClotTriever Intervention Arm) versus conservative medical management using
anticoagulation therapy alone (Conservative Medical Man1 expand
This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit. Type: Interventional Start Date: Jan 2023 |
Study of CHS-114 in Participants With Advanced Solid Tumors
Advanced Solid Tumor
Head and Neck Squamous Cell Carcinoma
This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of
SRF114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid
tumors. expand
This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of SRF114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid tumors. Type: Interventional Start Date: Dec 2022 |
A Study of ASP3082 in Adults With Advanced Solid Tumors
Solid Tumor
This is an open-label study. This means that people in this study and clinic staff will
know that they will receive ASP3082. The study aims to check how safe and well-tolerated
ASP3082 is for people with advanced solid tumors that have a specific mutation called
KRAS G12D.
This study will be in 21 expand
This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP3082 by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab, to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2. In Part 2, ASP3082 will be given in by itself, or in combination with other chemotherapy agents. Study treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. They will continue treatment until: they have medical problems from the treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop treatment. Type: Interventional Start Date: Jun 2022 |
A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants1
Advanced or Metastatic Colorectal Cancer
The purpose of this study is to assess the anti-tumor activity of amivantamab as a
monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added
to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer
(mCRC) (Ph2 cohorts), and to assess the1 expand
The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts), and to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts). Type: Interventional Start Date: Jul 2022 |
Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Metastatic Malignant Neoplasm in the Lung
Metastatic Osteosarcoma
Osteosarcoma
This phase III trial compares the effect of open thoracic surgery (thoracotomy) to
thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients
with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic
surgery is a type of surgery done through1 expand
This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better. Type: Interventional Start Date: Apr 2022 |
SPYRAL AFFIRM Global Study of RDN with the Symplicity Spyral RDN System in Subjects with Uncontroll1
Hypertension
Vascular Diseases
Cardiovascular Diseases
Chronic Kidney Diseases
Diabetes Mellitus
The purpose of this single-arm interventional study is to evaluate the long-term safety,
efficacy, and durability of the Symplicity Spyral system in subjects treated with renal
denervation.
Additionally, long-term follow-up data will also be collected from eligible subjects
previously treated in t1 expand
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies. Type: Interventional Start Date: Oct 2021 |
Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
Peripartum Cardiomyopathy, Postpartum
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5
months postpartum in a randomized placebo controlled trial of bromocriptine therapy to
evaluate its impact on myocardial recovery and clinical outcomes. Given that
bromocriptine prevents breastfeeding, an additi1 expand
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additional 50 women with peripartum cardiomyopathy excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort. Type: Interventional Start Date: Jul 2022 |
A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Withou1
Haemophilia A and B With and Without Inhibitors
This study will test how well a new medicine called concizumab works for participants who
have haemophilia A or B with or without inhibitors. The purpose is to show that
concizumab can prevent bleeds and is safe to use.
Participants will have to inject the study medicine every day under the skin w1 expand
This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use. Participants will have to inject the study medicine every day under the skin with a pen-injector. The study will last for at least 2 years and up to about 4 years. The length of time the participant will be in the study depends on if the study medicine will be available for purchase in their country. Type: Interventional Start Date: Mar 2022 |
Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease
Huntington Disease
Examine the effects of deutetrabenazine on functional speech and gait impairment expand
Examine the effects of deutetrabenazine on functional speech and gait impairment Type: Interventional Start Date: Nov 2021 |
Abatacept for the Treatment of Giant Cell Arteritis
Giant Cell Arteritis
This randomized, double-blind, placebo-controlled trial will seek to determine the
efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have
newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at
a 1:1 ratio to receive subcutaneous abat1 expand
This randomized, double-blind, placebo-controlled trial will seek to determine the efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at a 1:1 ratio to receive subcutaneous abatacept 125mg/week or placebo. Patients who achieve remission will remain on their blinded assignment for 12 months at which time abatacept/placebo will be stopped. Patients who do not achieve remission by Month 3, who experience a relapse within the first 12 months will have the option of receiving open-label abatacept for a maximum of 12 months. Type: Interventional Start Date: Mar 2021 |
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma
Low Grade Glioma
Metastatic Low Grade Astrocytoma
Metastatic Low Grade Glioma
This phase III trial compares the effect of selumetinib versus the standard of care
treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed
or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality
called BRAFV600E mutation and is not1 expand
This phase III trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes needed for cell growth and may kill tumor cells. Carboplatin and vincristine are chemotherapy drugs that work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for patients with LGG. Another goal of this study is to compare the effects of selumetinib versus CV in subjects with LGG to find out which is better. Additionally, this trial will also examine if treatment with selumetinib improves the quality of life for subjects who take it. Type: Interventional Start Date: Jan 2020 |
A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis1
Low Grade Glioma
Neurofibromatosis Type 1
Visual Pathway Glioma
This phase III trial studies if selumetinib works just as well as the standard treatment
with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma
(LGG), and to see if selumetinib is better than CV in improving vision in subjects with
LGG of the optic pathway (vision nerve1 expand
This phase III trial studies if selumetinib works just as well as the standard treatment with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low-grade glioma tumor cells need for their growth. This results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether selumetinib works better in treating patients with NF1-associated low-grade glioma compared to standard therapy with carboplatin and vincristine. Type: Interventional Start Date: Jan 2020 |
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cance1
Bladder Adenocarcinoma
Bladder Clear Cell Adenocarcinoma
Bladder Mixed Adenocarcinoma
Bladder Neuroendocrine Carcinoma
Bladder Small Cell Neuroendocrine Carcinoma
This phase II trial studies how well cabozantinib works in combination with nivolumab and
ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from
where it first started (primary site) to other places in the body. Cabozantinib may stop
the growth of tumor cells by bl1 expand
This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone. Type: Interventional Start Date: May 2019 |
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult1
Childhood Extracranial Germ Cell Tumor
Extragonadal Embryonal Carcinoma
Germ Cell Tumor
Malignant Germ Cell Tumor
Malignant Ovarian Teratoma
This phase III trial studies how well active surveillance help doctors to monitor
subjects with low risk germ cell tumors for recurrence after their tumor is removed. When
the germ cell tumor has spread outside of the organ in which it developed, it is
considered metastatic. Drugs used in chemother1 expand
This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors. Type: Interventional Start Date: May 2017 |
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