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NCT ID: NCT05630807 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)

B-Well 1
Start date: December 7, 2022
Phase: Phase 3
Study type: Interventional

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48. The arms will be stratified based on HBsAg level (HBsAg greater than or equal to [≥] 100 international unit per milliliter [IU/mL] to less than or equal [≤]1000 IU/mL or greater than [>] 1000 IU/mL to ≤3000 IU/mL) at screening. The total duration of the study, including screening (up to 60 days), the double-blind treatment stage (24 weeks), the On NA only stage (24 weeks), and the NA cessation and durability stages (48 weeks) is up to approximately 104 weeks at maximum for each participant.

NCT ID: NCT05630547 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Study to Evaluate the Effect of SAR443820 on Serum Neurofilament Levels in Male and Female Adult Participants With Multiple Sclerosis

Start date: December 19, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled 2 parallel-arm study to assess the effect on serum neurofilament light chain (sNfL), safety and tolerability of oral SAR443820 compared to placebo in male and female participants aged 18 to 60 years with relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) (relapsing or non-relapsing), or primary progressive multiple sclerosis (PPMS) followed by an open-label long-term extension period. The total study duration is approximately 100 weeks and includes the following: 4-week screening period 48-week double-blind treatment period (Part A) 48-week open-label long-term extension period (Part B)

NCT ID: NCT05630001 Active, not recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

Single Arm, Open Label Trial With Iptacopan Treatment for 24 Weeks, in Patients on Stable Regimen of Anti-C5 Who Switch to Iptacopan.

APPULSE
Start date: April 24, 2023
Phase: Phase 3
Study type: Interventional

The purpose of the study is to find out if iptacopan is effective and safe in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who switch from their current standard of care treatment (eculizumab or ravulizumab) to study treatment, iptacopan/LNP023.

NCT ID: NCT05626855 Active, not recruiting - Clinical trials for Neuromuscular Diseases

Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab-ONYX

ONYX
Start date: April 17, 2023
Phase: Phase 3
Study type: Interventional

The ONYX study is an Open-Label, Multicenter, Extension study that will evaluate the long-term safety and efficacy of Apitegromab in Patients with Type 2 and Type 3 SMA who have completed TOPAZ or SAPPHIRE.

NCT ID: NCT05623163 Active, not recruiting - Obesity Clinical Trials

Evaluation of Health Improvement in Obese Patients With Obesity-related Comorbidities Followed by EndoZip Procedure

CL00010
Start date: February 15, 2023
Phase: N/A
Study type: Interventional

multicenter, prospective, single arm study will include up to 45 patients, (up to 30 patients per site), aimed at evaluating the performance of the EndoZip System in obese patients with type 2 diabetes and / or hypertension who failed to reduce weight with non-surgical weight-loss methods. Patients will be enrolled in 2 clinical sites in Europe. Patients who meet the eligibility criteria is expected to come the clinic for at least 10 visits.

NCT ID: NCT05622162 Active, not recruiting - Prostate Cancer Clinical Trials

Prospective Comparative Study for Patients With Biochemical Recurrence Prostate Cancer Detecting by 18F-JK-PSMA-7

MIP7
Start date: December 19, 2022
Phase: Phase 3
Study type: Interventional

The present study in patients with Prostate cancer and biochemical failure after surgery and/or radical-postoperative Radio Therapy (RT) will evaluate if PET/CT with 18F-JK-PSMA-7 compared to PET-CT 18F-Choline is able to identify the early pattern of biochemical recurrence and/or metastatic sites, so that the patient could be better managed, with a benefit in survival.

NCT ID: NCT05610280 Active, not recruiting - Clinical trials for Cardiovascular Diseases

A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia

Start date: November 21, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.

NCT ID: NCT05608044 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer

Start date: November 30, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab or standard-of-care treatments in participants with refractory metastatic colorectal cancer.

NCT ID: NCT05601882 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Level Up
Start date: November 28, 2022
Phase: Phase 3
Study type: Interventional

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed. Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment period 1 and a 16-week treatment period 2. During period 1, participants are randomly assigned in 1 of 2 groups, called treatment arms to receive upadacitinib Dose A or dupilumab. In Period 2, participants will receive upadacitinib Dose A or Dose B. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide. Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label for 32 weeks and followed for 30 days. 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.

NCT ID: NCT05601141 Active, not recruiting - Pituitary Clinical Trials

Clinics and Epidemiology of Pituitary Diseases in Modena Area Population

DataPit
Start date: October 24, 2022
Phase:
Study type: Observational [Patient Registry]

This is an observational, longitudinal, single-center study. The study is divided in two phases: - FIRST PHASE (retrospective): registration of all patients affected by pituitary disorders followed at the Unit of Endocrinology of Azienda Ospedaliero-Universitaria of Modena - SECOND PHASE (prospective): enrollment of all patients affected by pituitary disorders who attend the Unit of Endocrinology of the Azienda Ospedaliero-Universitaria of Modena. An anonymized database will be created to collect the data of the patients. In particular, the data collected for each patient will include: personal data, data relating to pituitary pathology, symptoms at diagnosis, physical examination, radiological imaging, visual field data, data on surgical intervention, data on histological examination, biohumoral examinations, hormone tests, densitometric data, data on replacement therapies, medical therapies or other pharmacological therapies, data on comorbidities.