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NCT ID: NCT03754790 Active, not recruiting - Hemophilia Clinical Trials

Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX

ATLAS-OLE
Start date: January 9, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To characterize the long-term safety and tolerability of fitusiran Secondary Objectives: - To characterize the efficacy and long-term efficacy of fitusiran as assessed by the frequency of: - Bleeding episodes - Spontaneous bleeding episodes - Joint bleeding episodes - To characterize the effects of fitusiran on health-related quality of life (HRQOL) measures in participants ≥17 years of age

NCT ID: NCT03753347 Active, not recruiting - Influenza Clinical Trials

TITRE III: Influenza B Immunogenicity Investigation

Start date: December 1, 2018
Phase: Phase 4
Study type: Interventional

Each winter, viruses belonging to two kinds of influenza A ("A/H1N1" & "A/H3N2") and two kinds of influenza B ("B/Yamagata" & "B/Victoria") can cause illness. Historically, the yearly influenza vaccine that was recommended in children was designed to protect against both kinds of influenza A but only one kind of influenza B. In a series of trials conducted between 2008-09 and 2010-11 (TITRE I, II, and IIB), the TITRE investigators measured antibody response to influenza B in children who were primed with two doses of trivalent inactivated influenza vaccine (TIV) containing B/Yamagata. Overall, the investigators found that 2 doses of vaccine containing B/Yamagata did not adequately prime children for response to the alternate B/Victoria antigen and that subsequent vaccine doses containing B/Victoria-lineage antigen strongly boosted antibodies to the B/Yamagata antigen that was introduced during first immunization priming, but with lower responses to B/Victoria. For the first time since 2009-10, the recommended B/Victoria component of the seasonal influenza vaccine has been changed, from B/Brisbane/60/2008 to B/Colorado/60/2007 for the coming 2018-19 season. The investigators thus have a unique opportunity to clarify lineage-specific influenza B responses in a well-characterized cohort of children originally primed to Yamagata. The investigators' main interest is to assess whether TITRE I children primed with two doses of B/Yamagata in 2008-09 have since or are now capable of achieving a sufficient antibody response to B/Victoria following a single dose of 2018-19 QIV, ten years after their initial TIV B/Yamagata priming exposure.

NCT ID: NCT03748641 Active, not recruiting - Clinical trials for Castration-Resistant Prostatic Cancer

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

MAGNITUDE
Start date: January 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.

NCT ID: NCT03745287 Active, not recruiting - Sickle Cell Disease Clinical Trials

A Safety and Efficacy Study Evaluating CTX001 in Subjects With Severe Sickle Cell Disease

Start date: November 27, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a single-arm, open-label, multi-site, single-dose Phase 1/2/3 study in subjects with severe sickle cell disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (hHSPCs) using CTX001.

NCT ID: NCT03744832 Active, not recruiting - Pharyngitis Acute Clinical Trials

Point of Care Streptococcal Pharyngitis Testing

Start date: August 12, 2019
Phase: N/A
Study type: Interventional

Sore throat is a common problem in children typically caused by viral or bacterial infections. While viral infections resolve without treatment, bacterial infections, such as "strep throat," are treatable with antibiotics. Diagnosing "strep throat" traditionally required a throat swab for culture that delays treatment for several days. This may result in prolonged illness, activity absenteeism, and significant healthcare costs. New molecular tests can accurately diagnose "strep throat" within 8 minutes, but are more expensive and require impact evaluation before widespread implementation. This study will compare a new bedside molecular test with conventional throat cultures to evaluate for benefits to patients and families seen in the emergency department, as well to healthcare system operations. The investigators hypothesize that care for children and the associated healthcare costs will improve with these point of care molecular tests.

NCT ID: NCT03740165 Active, not recruiting - Ovarian Cancer Clinical Trials

Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)

Start date: December 18, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.

NCT ID: NCT03737721 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of the Skin

The UNSCARRed Study: UNresctable Squamous Cell Carcinoma Treated With Avelumab and Radical Radiotherapy

UNSCARRed
Start date: April 12, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out what effects the combination of radiation therapy and Avelumab have on you and your cancer. The effectiveness of this treatment as well as what side effects occur will both be studied. Squamous cell carcinoma of the skin is the most commonly diagnosed cancer. Risk factors for the development of squamous cell cancer include ultraviolet (sun) exposure, as well as increasing age. In the majority of instances, a minor surgical procedure is curative. Less commonly, squamous cell carcinoma cannot be removed surgically, due to the location and/or extent of the cancer, or due to patient-specific factors which would make surgery unsafe (for instance, the presence of unrelated medical illnesses such as heart disease or stroke). When squamous cell carcinoma cannot be removed surgically, radiation therapy may serve as an effective alternative treatment. Squamous cell carcinomas are typically very sensitive to radiation, and in some instances radiation therapy may also cure a person of their cancer. While some people may be cured by radiation therapy, not all people are. This study is investigating the combination of radiation therapy and immune therapy. When given together, more patients may be cured of their cancer. Immune therapy is effective for the treatment of squamous cell carcinoma. In clinical trials, more than half of patients benefit from immune therapy. Immune therapy is not chemotherapy. Instead, immune therapy involves the infusion of antibodies which target a person's own immune system. Immune therapy "re-activates" a person's own immune system against their cancer. The treatment offered within this clinical trial includes daily radiation treatments as well as immunotherapy treatments administered once every two weeks. The immunotherapy in use is a drug called Avelumab, which is an antibody that helps your body's immune system fight cancer. Health Canada, the regulatory body that oversees the use of natural health products, drugs and devices in Canada, has not approved the sale or use of this product to treat this kind of cancer, although they have allowed its use in this study

NCT ID: NCT03737643 Active, not recruiting - Clinical trials for Advanced Ovarian Cancer

Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients

DUO-O
Start date: January 4, 2019
Phase: Phase 3
Study type: Interventional

This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.

NCT ID: NCT03737214 Active, not recruiting - Fabry Disease Clinical Trials

A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease

Start date: December 18, 2018
Phase: Phase 3
Study type: Interventional

A study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease

NCT ID: NCT03734029 Active, not recruiting - Breast Cancer Clinical Trials

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

Start date: December 27, 2018
Phase: Phase 3
Study type: Interventional

This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: - Cannot be removed by an operation - Has spread to other parts of the body