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NCT ID: NCT05005975 Active, not recruiting - XLP Clinical Trials

Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

Start date: August 10, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the long-term safety and tolerability of oral dersimelagon.

NCT ID: NCT05005195 Active, not recruiting - Clinical trials for Renal Cell Carcinoma

Yorkshire Kidney Screening Trial

YKST
Start date: May 10, 2021
Phase: N/A
Study type: Interventional

Kidney cancer is the 8th most common cancer in Yorkshire. It has a poor survival rate, with only 6 out of 10 patients diagnosed with kidney cancer still alive after 5 years. This is partly because many people with kidney cancer don't have any symptoms. In some of these people, kidney cancer is only found by chance during investigations for other reasons. In others, it is often not diagnosed until the disease has passed the point at which we can easily cure it. Screening for kidney cancer has the potential to pick up these cancers earlier and increase the number of people who can be cured. The Yorkshire Lung Screening Trial offers people aged 55-80 with a history of smoking a CT scan as part of a lung health check. This group of people is also at increased risk of developing kidney cancer. Our new study, the Yorkshire Kidney Screening Trial, will piggyback on this trial to offer an extra CT scan for kidney cancer. The extra scan will take 10 seconds. By the end of the study we will understand whether it is workable to roll this out more widely and whether people take up this extra scan.

NCT ID: NCT05004675 Active, not recruiting - Clinical trials for Hypercholesterolemia

Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients

LIBerate-VI
Start date: June 20, 2022
Phase: Phase 3
Study type: Interventional

Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy

NCT ID: NCT05002998 Active, not recruiting - Thyroid Eye Disease Clinical Trials

TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study

Start date: September 16, 2021
Phase: Phase 4
Study type: Interventional

This is a double-masked, randomized, parallel-assignment, multicenter trial examining the safety and tolerability of teprotumumab in the treatment of Thyroid Eye Disease (TED) in adult participants. This international, Phase 3b/4 trial is being conducted to fulfill an FDA post-marketing requirement for a descriptive trial to evaluate the safety, efficacy and need for re-treatment of 3 different teprotumumab treatment durations for TED. In addition, serum samples from participants with a Baseline Clinical Activity Score (CAS) ≥3 will be evaluated for biomarkers of disease.

NCT ID: NCT05002777 Active, not recruiting - Clinical trials for Warm Autoimmune Hemolytic Anemia (wAIHA)

Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)

Start date: December 7, 2021
Phase: Phase 2
Study type: Interventional

This is a single group treatment, Phase 2, open-label, study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in adult patients with wAIHA. All participants will receive rilzabrutinib orally. The screening period is up to 28 days, followed by a treatment period of 24 weeks for Part A. Participants who complete Part A and are deemed eligible for Part B will continue to receive the study medication for 52 weeks following the Last Patient In (LPI-Part B). There will be a 7-day safety follow-up period after receiving the last dose of study drug either in Part A (for those not eligible for Part B or early terminated) or Part B. The estimated total duration of the study is approximately 137 weeks (Parts A and B), including the follow-up period. For participants deemed ineligible for Part B, the total length of the study will be 29 weeks (Part A only), including screening and the follow-up period. In Part B, participants who temporarily stop rilzabrutinib treatment and maintain a durable response from W50 to W74, will have their EOS visit at Week 75. In this case, participation will be for 79 weeks including the screening period.

NCT ID: NCT05002569 Active, not recruiting - Melanoma Clinical Trials

A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

RELATIVITY-098
Start date: October 19, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

NCT ID: NCT05000242 Active, not recruiting - Clinical trials for Inflammatory Bowel Diseases

West Hertfordshire Inflammatory Bowel Disease Technology Study

WHITS
Start date: January 31, 2022
Phase:
Study type: Observational

A retrospective and prospective, observational, non-interventional, cohort study to develop quantitative metrics from tools used as standard of care when diagnosing, assessing and monitoring patients with inflammatory bowel disease.

NCT ID: NCT04999423 Active, not recruiting - Clinical trials for Intracranial Aneurysm

LVIS™ Evo™ and HydroCoil® Embolic System for Intracranial Aneurysm Treatment

SEALANT
Start date: January 14, 2022
Phase:
Study type: Observational

This is a prospective multicenter international single-arm observational study to demonstrate that use of stent-assisted coiling with LVIS™ Evo™ and HydroCoil® Embolic System (HES) in intracranial aneurysm treatment is effective and safe when assessed at 1 year after the procedure

NCT ID: NCT04999202 Active, not recruiting - Clinical trials for Advanced Solid Tumors

A Study to Learn How Safe the Study Drug BAY 2416964 (AhR Inhibitor) in Combination With the Treatment Pembrolizumab is, How This Combination Affects the Body, the Maximum Amount That Can be Given, How it Moves Into, Through and Out of the Body and Its Action Against Advanced Solid Cancers in Adults

Start date: August 30, 2021
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat advanced solid cancers including head and neck cancer, lung cancer and bladder cancer. In some people with cancer a protein called Aryl Hydrocarbon Receptor (AhR) can prevent immune cells from fighting tumor cells. The study drug, BAY 2416964, is a small molecule which blocks the AhR allowing the body to use its immune response against the cancer cells. Researchers think that BAY 2416964 given together with a cancer treatment called pembrolizumab may help shrink tumors in people with cancer. The main aims of this study are to find for BAY 2416964 in combination with pembrolizumab, - how safe this drug combination is - how it affects the body (also referred to as tolerability) - the highest amount of BAY 2416964 that can be given in combination with pembrolizumab without too many side effects. The researchers will also study the action of BAY 2416964 in combination with pembrolizumab against the cancer. The participants in this study will get BAY 2416964 and pembrolizumab. BAY 2416964 will be given by mouth. Pembrolizumab will be given as an intravenous (IV) infusion. An IV infusion is given through a needle into a vein. This study will have two parts. The first part will help find the most appropriate dose that can be given in the second part. Each participant of the first, so called dose escalation part, will be assigned to one specific dose group for BAY 2416964. The amount of BAY 2416964 that is given changes step-wise from one group to the next. The dose of pembrolizumab will always be the same. The participants of the second, so called dose expansion part, will receive the most appropriate dose of BAY 2416964 found in the first part. During the study, the participants will receive the treatment in 3-week periods called cycles. In each cycle, the participants will in general get pembrolizumab once and BAY 2416964 in a daily schedule. These 3-week cycles will be repeated throughout the trial. The participants can take the study treatment until their cancer gets worse, until they have medical problems, or until they leave the trial. Participants will have around 4 visits in each cycle. Some of the visits can also be done via phone. During the study, the study doctors and their team will: - take blood and urine samples - check if the participants' cancer has changed in size using computed tomography scans or magnetic resonance imaging scans of the participants' tumors - check the participants' overall health - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT04998851 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab

SOPRANINO
Start date: September 16, 2021
Phase: Phase 4
Study type: Interventional

This study will evaluate the pharmacokinetics of ocrelizumab in the breastmilk of lactating women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] treated with ocrelizumab, by assessing the concentration of ocrelizumab in mature breastmilk, as well as the corresponding exposure and pharmacodynamic effects (blood B cell levels) in the infants.