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NCT ID: NCT04535544 Active, not recruiting - Clinical trials for Hepatitis D, Chronic

A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

REEF-D
Start date: September 17, 2020
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.

NCT ID: NCT04532645 Active, not recruiting - Ovary Cancer Clinical Trials

Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK

OVAL-1
Start date: December 11, 2020
Phase:
Study type: Observational

This is a retrospective observational medical records review study of BRCA mutated advanced (FIGO stage III-IV) ovarian cancer patients who received first dose maintenance olaparib in 1L setting in France, Italy and the UK. Physicians who treated ovarian cancer patients with olaparib in 1L setting will be requested to recruit patients to have their clinical data abstracted from their clinical records in line with local laws

NCT ID: NCT04527991 Active, not recruiting - Clinical trials for Locally Advanced or Metastatic Unresectable Urothelial Cancer

Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician's Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer

TROPiCS-04
Start date: January 13, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).

NCT ID: NCT04527432 Active, not recruiting - Clinical trials for Coronavirus Infection

COVID-19 Health Professional Impact Study

CHIP
Start date: November 24, 2020
Phase: N/A
Study type: Interventional

The COVID-19 (coronavirus) pandemic has had a huge impact on healthcare resources and staff in the UK. Understanding the key risk factors associated with infection amongst healthcare workers is essential for future pandemic response plans. Currently there are scarce data relating to the infection rates and associated factors amongst healthcare workers in the United Kingdom (UK). Studies of infection rates in healthcare workers have largely relied on the real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test to date and it appears that Healthcare workers are twice as likely to succumb to Coronavirus infection, when compared to the general population and those from Black and minority ethnic (BAME) backgrounds appear to be particularly at risk. Currently there is no evidence that the presence of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibodies provides seasonal or long term immunity to future infection. Therefore, this study aims to understand the current level of SARS-CoV-2 antibody positivity and try to determine the likely risk to healthcare workers in the UK to COVID-19 infection. This study hopes to find out whether certain individual characteristics will have an impact on likelihood of infection susceptibility and antibody response and determine the impact of the presence of antibodies on the likelihood of future clinical infection over a 12 month period. The study involves an initial online survey and linkage to the recent antibody test, then a further online survey in 6 and 12 months' time. The data obtained will be linked to data that the Human Resources Department (HR) holds. Participants also have the option to partake in another antibody test at 6 and 12 months' time and linked to the data collected.

NCT ID: NCT04527380 Active, not recruiting - Clinical trials for Juvenile Psoriatic Arthritis

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

Start date: April 13, 2021
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if the study drug ixekizumab is safe and effective in children with juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) (including juvenile onset ankylosing spondylitis [JoAS]) and juvenile psoriatic arthritis (JPsA).

NCT ID: NCT04526899 Active, not recruiting - Clinical trials for Unresectable Melanoma

Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma

Start date: May 19, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-programmed death protein 1 (PD-1)/anti-programmed death ligand 1 (PD-L1)-refractory/relapsed patients with unresectable Stage III or IV melanoma. The contributions of BNT111 and cemiplimab will be delineated in single agent calibrator arms. Patients will be randomized in a 2:1:1 ratio to Arm 1 (BNT111 + cemiplimab) and calibrator Arm 2 (BNT111 monotherapy), and Arm 3 (cemiplimab monotherapy). Patients in single agent calibrator arms (Arms 2 and 3), who experience centrally verified disease progression under single agent treatment, may be offered addition of the other compound to the ongoing treatment after re-consent.

NCT ID: NCT04526665 Active, not recruiting - Clinical trials for Primary Biliary Cirrhosis

Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)

ELATIVE
Start date: September 24, 2020
Phase: Phase 3
Study type: Interventional

The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver disease). PBC is a slowly progressive disease characterized by damage of the bile ducts in the liver, leading to a buildup of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study has two main parts; the first part will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment), and will last between a minimum of one year and a maximum of two years. In the second part, all participants will receive elafibranor, for a period between 4-5 years. The main aim of this study is to determine if elafibranor is better than placebo at decreasing the levels of a specific blood test (alkaline phosphatase) that provides information about participant's disease. This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as pruritus and fatigue.

NCT ID: NCT04526106 Active, not recruiting - Cholangiocarcinoma Clinical Trials

REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors

Start date: September 2, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic cholangiocarcinoma (CCA) and other solid tumors. The study consists of 3 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3).

NCT ID: NCT04524949 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 1

IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT Study)

IMPACT
Start date: December 29, 2020
Phase: Phase 2
Study type: Interventional

The IMPACT study is a study to test a new experimental drug, IMCY-0098, for the treatment of type 1 diabetes (T1D). In most people with type 1 diabetes, the pancreas loses its ability to make insulin because some cells of the body's own immune system mistakenly attack and destroy the cells in the pancreas that produce insulin (islet beta-cells). The study drug IMCY-0098 is being developed to stop the body's own immune system attacking and destroying the insulin-producing cells. When injected, it will induce new immune cells that will specifically destroy the bad immune cells responsible for the damage to the pancreas. IMCY-0098 has previously been tested on recently diagnosed type 1 diabetes patients in the first clinical study between 2017 and 2019 to collect information on the safety of IMCY-0098. The next step is to test the best dose and the best number of injections that show the drug can give a benefit. Two doses of IMCY-0098 will be tested and they will be compared to a placebo. Safety information will also be collected during the study for all the participants.

NCT ID: NCT04524611 Active, not recruiting - Clinical trials for Crohn's Disease (CD)

Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)

SEQUENCE
Start date: September 30, 2020
Phase: Phase 3
Study type: Interventional

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide. In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.