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NCT ID: NCT04008706 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients

ASSURE
Start date: September 17, 2019
Phase: Phase 3
Study type: Interventional

This is a global, Phase IIIb, multicenter, open-label, single-arm study to evaluate the safety and efficacy of acalabrutinib 100 mg twice daily (bid) in approximately 540 participants with chronic lymphocytic leukemia (CLL). Participants will be enrolled into 3 following cohorts: treatment-naive (TN), relapsed/refractory (R/R), and prior ibrutinib therapy. For this study, participants in the UK will be enrolled ONLY into the R/R cohort or the prior ibrutinib cohort. Participants in the US will be enrolled ONLY into the TN or R/R cohort. Participants will remain on study intervention until completion of 48 cycles (28 days per cycle), or until study intervention discontinuation due to, for example disease progression, or toxicity, withdrawal of consent, loss to follow-up, death, or study termination by the sponsor whichever occurs first. The duration of the study will be approximately 72 months from the first participant enrolled. This duration includes an estimated 24-month recruitment time and an assumed 48 cycles of study intervention (28 days per cycle); additional study time will be accrued during the Disease Follow up period for those participants remaining on study intervention after completion of 48 cycles prior to the final data cutoff (DCO) (the amount of time will vary by participant).

NCT ID: NCT04006457 Active, not recruiting - Alopecia Areata Clinical Trials

Long-Term PF-06651600 for the Treatment of Alopecia Areata

ALLEGRO-LT
Start date: July 18, 2019
Phase: Phase 3
Study type: Interventional

This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug. A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.

NCT ID: NCT04006210 Active, not recruiting - Parkinson's Disease Clinical Trials

Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations

BouNDless
Start date: September 30, 2019
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blind, double-dummy, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR-LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR-LD/CD. Subjects can continue to an optional open-label extension period.

NCT ID: NCT04004182 Active, not recruiting - Clinical trials for Glucose Metabolism Disorders

Acute Study of Anthocyanin-rich Bilberry and Polyphenol-rich Apple Extracts on Postprandial Glycaemic Response

Start date: June 8, 2019
Phase: N/A
Study type: Interventional

Strategies to control chronic postprandial hyperglycaemia by optimizing the functionality of foods would strengthen efforts to reduce the risk of developing T2D in the general population. Polyphenolic constituents, may help to delay starch and disaccharide digestion and glucose absorption following a carbohydrate-containing meal or beverage. In vitro studies suggest that some berry anthocyanins and apple polyphenols are effective inhibitors of digestive enzymes, α-amylases and α-glucosidases. Furthermore, polyphenols found in berries and apples inhibit the action of intestinal glucose transporters. Human data is limited; however, randomized controlled trials (RCTs) have shown that berries and apple products reduced postprandial glucose concentrations following consumption of either starch, glucose or sucrose loads. The aim of this study is to test the hypothesis that consumption of a fruit bar containing anthocyanin-rich bilberry and polyphenol-rich apple extracts together with a starch and sucrose meal would reduce the postprandial glycemic response. This study is a randomized cross over study and will aim to recruit 24 overweight (BMI > 25.0), men or post-menopausal women, aged ≥40 and ≤ 70 years who will attend four study sessions. The first study session will be an oral glucose tolerance test (OGTT) and the remaining three will be identical in all respects except for the composition of the fruit bar. Consecutive blood samples will be collected in all 4 study sessions which will be used to measure glucose, insulin, C-peptide, incretins and lipids.

NCT ID: NCT04004065 Active, not recruiting - Clinical trials for Duchenne Muscular Dystrophy

Two-Part Study for Dose Determination of Vesleteplirsen (SRP-5051) (Part A), Then Dose Efficacy (Part B) in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping Treatment

MOMENTUM
Start date: June 26, 2019
Phase: Phase 2
Study type: Interventional

This study will be comprised of 2 parts: 1) Part A (Multiple Ascending Dose [MAD]) will be conducted to evaluate the safety and tolerability of vesleteplirsen at MAD levels to determine the maximum tolerated dose (MTD), and 2) Part B will be conducted to further evaluate the vesleteplirsen doses selected in Part A. Participants enrolling in Part B will be those who completed Part A or Study 5051-102 (NCT03675126) and meet applicable eligibility criteria for Part B, as well as additional participants who meet applicable eligibility criteria for enrollment at the beginning of Part B.

NCT ID: NCT04003636 Active, not recruiting - Clinical trials for Biliary Tract Carcinoma

Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)

KEYNOTE-966
Start date: September 24, 2019
Phase: Phase 3
Study type: Interventional

This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).

NCT ID: NCT03997383 Active, not recruiting - Clinical trials for Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

APOLLO-B: A Study to Evaluate Patisiran in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

Start date: September 4, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of patisiran in participants with ATTR amyloidosis with cardiomyopathy.

NCT ID: NCT03997123 Active, not recruiting - Clinical trials for Triple Negative Breast Neoplasms

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

CAPItello-290
Start date: June 25, 2019
Phase: Phase 3
Study type: Interventional

Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)

NCT ID: NCT03996590 Active, not recruiting - Asthma Clinical Trials

Wessex Asthma Cohort of Difficult Asthma

WATCH
Start date: April 22, 2015
Phase:
Study type: Observational [Patient Registry]

Asthma is now widely recognised to be a heterogeneous disease. The last two decades have seen the identification of a number of biological targets and development of various novel therapies. Despite this, asthma still represents a significant health and economic burden worldwide. Why some individuals should continue to suffer remains unclear. The Wessex Asthma Cohort of Difficult Asthma (WATCH) is an ongoing 'real-life', prospective study of patients in the University Hospital Southampton Foundation Trust (UHSFT) Difficult Asthma service. Research data capture is aligned with the extensive clinical characterisation required of a commissioned National Health Service (NHS) Specialist Centre for Severe Asthma. Data acquisition includes detailed clinical, health and disease-related questionnaires, anthropometry, allergy and lung function testing, radiological imaging (in a small subset) and collection of biological samples (blood, urine and sputum). Prospective data are captured in parallel to clinical follow up appointments, with data entered into a bespoke database. The pragmatic ongoing nature of the WATCH study allows comprehensive assessment of the real world clinical spectrum seen in a Specialist Asthma Centre and allows a longitudinal perspective of deeply phenotyped patients. It is anticipated that the WATCH cohort would act as a vehicle for potential collaborative asthma studies and will build upon our understanding of mechanisms underlying difficult asthma.

NCT ID: NCT03994783 Active, not recruiting - Clinical trials for Kidney Transplant Rejection

Transplant Antibody-Mediated Rejection: Guiding Effective Treatments

TAR:GET-1
Start date: July 17, 2019
Phase: Phase 3
Study type: Interventional

This trial evaluates the addition of rituximab to standard of care in the treatment of antibody-mediated rejection in kidney transplant patients. The trial will involve adults and children. Half of participants will receive standard of care (methylprednisolone, intravenous immunoglobulin and plasma exchange), while the other half will receive standard of care and rituximab.