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NCT ID: NCT04161495 Completed - Clinical trials for Factor VIII Deficiency

A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A

XTEND-1
Start date: November 19, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: - To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm. Secondary Objectives: - To evaluate the efficacy of BIVV001 as a prophylaxis treatment. - To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes. - To evaluate BIVV001 consumption for the prevention and treatment of bleeding episodes. - To evaluate the effect of BIVV001 prophylaxis on joint health outcomes. - To evaluate the effect of BIVV001 prophylaxis on Quality of Life outcomes. - To evaluate the efficacy of BIVV001 for perioperative management. - To evaluate the safety and tolerability of BIVV001 treatment. - To assess the pharmacokinetics (PK) of BIVV001 based on the 1-stage activated partial thromboplastin time (aPTT) and 2-stage chromogenic coagulation factor VIII (FVIII) activity assays.

NCT ID: NCT04161235 Completed - Pulmonary Emphysema Clinical Trials

Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV

Start date: February 5, 2020
Phase:
Study type: Observational [Patient Registry]

This is a Post-Market Evaluation of the Zephyr Valve 5.5-LP EBV to assess Treated Lobar Volume Reduction (TLVR), changes in lung function and the safety profile of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV.

NCT ID: NCT04159545 Completed - Hepatitis C Clinical Trials

Future Destinations: Journeys Towards Citizenship

Start date: December 15, 2019
Phase:
Study type: Observational

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), if left untreated it can lead to chronic liver disease, cirrhosis and cancer. HCV is a blood borne virus, the key risk group for HCV infection are those who currently inject drugs, or have done in the past. For many years the treatment of chronic HCV infection was based on therapies that had significant side effects, long treatment period and were between 50-70% effective, this impacted on patient acceptability and compliance. However, for those completing the treatment and undergoing this "personal trial" literature describes the transformative experience of HCV cure and how people took steps towards a "normal life" moving beyond substance use. Recent advances in Direct-Acting Antiviral (DAA) medicines available to cure HCV have transformed treatment with shorter treatment periods, few side effects, ease of administration and improved efficacy. However, there is a potential paradox, in that the DAA-based regimes provide a reliable cure, for a large majority of patients, with a relatively small treatment burden, but may not be a "personal trial" and may have a lesser impact on rehabilitation and recovery from substance use. The success of attempts of the group cured of HCV with DAAs, to progress down a recovery pathway and to resume activities thought of as being part of normal citizenship, are therefore unclear. This study will examine the types of activities that people cured of HCV undertake and the success of their recovery pathway, post-treatment with DAAs over a two year follow-up period.

NCT ID: NCT04159519 Completed - Asthma Clinical Trials

A Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients With Severe Eosinophilic Asthma Treated With Benralizumab

Start date: July 27, 2020
Phase: Phase 4
Study type: Interventional

This is a multicentre, randomised, open-label, parallel-group, active-controlled, phase IV study to assess the reduction of daily Symbicort® maintenance to anti-inflammatory reliever treatment only in participants with severe eosinophilic asthma on Fasenra® treatment, while maintaining asthma control.

NCT ID: NCT04158453 Completed - Healthy Volunteer Clinical Trials

Safety, Blood Levels and Effects of AUT00201

Start date: October 10, 2019
Phase: Phase 1
Study type: Interventional

The study medicine is a potential future treatment for schizophrenia, an illness that affects the way that people think, feel or behave. It is not clear what causes schizophrenia, but it's been linked to chemical imbalance in the brain. It is hoped that the study medicine will activate specific sites in the brain to help correct that imbalance. Current treatments for schizophrenia don't work very well and can cause unpleasant side effects. It is hoped that the study medicine will work better, and have fewer side effects than existing medicines. In this 2 part study (Part A: up to 40 healthy male subjects and up to 8 healthy female subjects, Part B: up to 32 healthy male subjects) the primary aim is to assess how safe the study medicine is in healthy men and women. This study will be in 2 parts, as follows: Part A will assess single doses of AUT00201 and Part B will assess multiple doses. Part A will be divided into 3 sub-parts: Part A1 will assess single ascending doses in healthy men, Part A2 will assess single ascending doses in healthy women, and Part A3 will assess the effect of food on the PK of AUT00201 in healthy men. A pharmaceutical company, Autifony Therapeutics Limited, is funding the study. The study will take place at 1 centre in London.

NCT ID: NCT04157855 Completed - Abdominal Pain Clinical Trials

Abdominal Plane Blocks (APB) in Chronic Abdominal Pain (CAP)

Start date: January 9, 2019
Phase:
Study type: Observational

Background: Chronic Abdominal Pain (CAP) is the sixth most common cause of hospital admission from any cause in women and the tenth most common cause in men. In the UK, it has been estimated that chronic abdominal pain costs the economy in excess of £100 million per annum. The mechanism of CAP is poorly understood. Patients with acute exacerbation of their CAP have multiple hospital admissions, prolonged length of stay and utilise significant health care resources. These patients have undergone multiple investigations with negative results leading to frustration for both the patient and the clinician. Additional testing and investigations increases costs, patient morbidity and comes with added risks. Patients are discharged once the flare up settles. The investigators have shown that treating patients with steroid injection followed by pulsed radio frequency treatment six months later can reduce the length of stay, repeat hospital admission, improve mood and provide durable pain relief in patients with CAP. The steroid is injected into a specific plane in the abdominal wall and is called abdominal plane block (APB). The investigators currently offer ABP treatment as a standard treatment in the management of patients with CAP. Aim of the study is to evaluate the effectiveness of Abdominal Plane Block (APB) treatment in reducing hospital readmission over 12 months in patients admitted with exacerbation of CAP Methods: The proposed study is a prospective, observational pilot study that will be conducted at Leicester General Hospital over 36 months. After providing written consent, adult patients admitted to the hospital with acute exacerbation of CAP will receive two sequential APB treatments (steroid injection followed by pulsed radio frequency treatment) six month apart. If the first treatment with steroid does not provide any benefit, the participants will receive a rescue treatment (trigger point injection with steroids). Participants will be asked to complete questionnaires on pain scores, mood and quality of life. Length of hospital stay, number of hospital re-admission following APB treatment as well as any complication from the APB treatment will be recorded. Participation in the study will end at 12 months following the first APB treatment on completion of relevant questionnaires.

NCT ID: NCT04157712 Completed - Alzheimer Disease Clinical Trials

Multiple Ascending Dose Study of ALZ-801

Start date: September 26, 2015
Phase: Phase 1
Study type: Interventional

Phase I, single-center, double-blind, randomized, placebo-controlled, parallel-group study of the safety, tolerability, and pharmacokinetics (PK) in plasma and urine, of multiple ascending doses of ALZ-801 (capsule, Part 1; prototype tablet Part 2) and the primary metabolite in healthy male or female subjects.

NCT ID: NCT04157686 Completed - Glabellar Lines Clinical Trials

MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)

Start date: October 23, 2019
Phase: Phase 3
Study type: Interventional

To evaluate the long-term safety of MT10109L in the treatment of GL and/or LCL in participants with moderate to severe GL and/or LCL.

NCT ID: NCT04157010 Completed - Clinical trials for Rheumatoid Arthritis

Tocilizumab REMission in Early RA

TREMERA
Start date: May 2013
Phase: Phase 4
Study type: Interventional

The TREMERA study focuses on patients with newly diagnosed, untreated, rheumatoid arthritis (RA). Recent international treatment recommendations emphasise the need to diagnose RA early and start treatment immediately (this being associated with better response rates); and to aim for the goal of remission i.e. the absence of signs and symptoms of active inflammatory disease activity which is associated with better outcomes for the patient. Remission is more achievable with significant treatment advances that have been made in the form of highly effective biologic therapies. Tocilizumab (TCZ) is a newly introduced biologic drug that is used in established RA. The TREMERA study primarily aims to investigate the biological changes seen in blood and tissue following TCZ therapy this will contribute to a better understanding of how the drug works as well as disease processes; and will also identify whether administering a biologic drug such as TCZ can also switch off immunological parameters associated with a disrupted immune system of RA. The study will assess the effectiveness of TCZ given on its own or in combination with methotrexate (MTX; a standard therapy usually given with biologic treatments)in patients with early onset RA to determine the proportion that achieve remission. This study also aims to find out how quickly remission can be achieved with TCZ and the depth of remission achieved. This will be done using usual clinical assessment but also imaging such as ultrasound and magnetic resonance imaging (MRI) which can detect inflammation not apparent on clinical assessment.

NCT ID: NCT04156386 Completed - Muscle Recovery Clinical Trials

Vegan or Animal Protein Ingestion on the Recovery of Muscle Function Following Exercise

VAMPIRE
Start date: September 23, 2019
Phase: N/A
Study type: Interventional

This study will assess the effect of daily post-exercise vegan (pea) and animal (whey) protein ingestion compared to placebo over 7 days of recovery from strenuous exercise. Muscle strength and soreness will be measured daily, and mechanisms underpinning recovery will be investigated in muscle biopsies taken 3, 24 and 48 hours after exercise.