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NCT ID: NCT05635084 Recruiting - Clinical trials for Cardiovascular Diseases

A First-in-human Study of YN001 in Healthy Volunteers

Start date: December 16, 2022
Phase: Phase 1
Study type: Interventional

This will be a single center, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study in healthy adult subjects.

NCT ID: NCT05633355 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

ROCKET-Orbit
Start date: January 30, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

NCT ID: NCT05631093 Active, not recruiting - HIV-1 Infection Clinical Trials

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)

Start date: February 20, 2023
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the safety and tolerability of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued baseline antiretroviral therapy (ART), through Week 48; and to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued baseline ART at Week 48. The primary hypothesis is that DOR/ISL is non-inferior to continued baseline ART, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority.

NCT ID: NCT05630820 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)

B-Well 2
Start date: December 6, 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: NCT05630755 Active, not recruiting - HIV-1 Infection Clinical Trials

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)

Start date: February 17, 2023
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued BIC/FTC/TAF at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF, through Week 48. The primary hypotheses are that (1) DOR/ISL is non-inferior to continued BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority; and (2) DOR/ISL is superior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.

NCT ID: NCT05630066 Recruiting - Angelman Syndrome Clinical Trials

Study to Investigate the Pharmacokinetics and Safety and to Provide Proof of Mechanism of Alogabat in Children and Adolescents Aged 5-17 Years With Angelman Syndrome (AS) With Deletion Genotype.

Aldebaran
Start date: July 27, 2023
Phase: Phase 2
Study type: Interventional

This is a two-part, Phase IIa, multicenter, 12-week, open-label study. Up to 56 participants with deletion Angelman Syndrome (AS) aged 5-17 years (inclusive) will be enrolled in the study.

NCT ID: NCT05629559 Active, not recruiting - Fabry Disease Clinical Trials

4D-310 in Adults With Fabry Disease and Cardiac Involvement

Start date: October 16, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a prospective multicenter, open-label, dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of 4D-310 following a single IV administration. The study population is comprised of adult males and females with Fabry Disease and cardiac involvement

NCT ID: NCT05629416 Recruiting - Clinical trials for Access to Interpreters

The Communicate Study Partnership

Start date: May 23, 2022
Phase: Phase 2
Study type: Interventional

The vision of the Communicate Study Partnership is to ensure more Aboriginal patients receive culturally safe healthcare in their first language. The Communicate Study Partnership will implement and evaluate creative ways to embed cultural safety training and increase use of Aboriginal Interpreters and Aboriginal Health Practitioners at Northern Territory Top End hospitals. Quantitative outcomes (interpreter uptake, outcomes including leave against medical advice, costs) will be measured using time-series analysis. Qualitative outcomes derived from interviews with patient, healthcare provider and interpreter participants, will be informed by decolonising theory and participatory approaches. Successful project implementation will improve experience of care and health outcomes for Aboriginal people, build Aboriginal workforce, and improve healthcare provider satisfaction.

NCT ID: NCT05629364 Terminated - Dry Eye Disease Clinical Trials

A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease

Start date: March 15, 2023
Phase: Phase 2
Study type: Interventional

A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, versus Vehicle Control in the treatment of Dry Eye Disease in Patients with Autoimmune Disease

NCT ID: NCT05628636 Completed - Alzheimer Disease Clinical Trials

AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions

Start date: November 14, 2022
Phase: Phase 1
Study type: Interventional

This is an open-label, 3-arm study to compare tolerability of three different titration and dosing schedules of the AC-OLE-01-VA formulation of tricaprilin. Following a screening of up to 28 days, eligible participants will be initially randomised to one of 2 arms (Arm 1 or Arm 2). Arms 1 and 2 will be completed in advance of Arm 3 with all subsequent participants allocated to Arm 3.