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NCT ID: NCT05363839 Terminated - Healthy Volunteers Clinical Trials

To Assess the Safety, Tolerability and Pharmacokinetics of ACH-000029 in Healthy Subjects

Start date: May 6, 2022
Phase: Phase 1
Study type: Interventional

Randomized single ascending dose placebo controlled treatment of ACH-000029 administered orally via capsule in healthy volunteers.

NCT ID: NCT05363605 Terminated - Breast Cancer Clinical Trials

A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours

Start date: April 20, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This first-in-human study evaluates safety, tolerability and distribution of [225Ac] FPI-1966, [111In]-FPI-1967, and vofatamab in patients with FGFR3-expressing solid tumors.

NCT ID: NCT05356403 Terminated - Clinical trials for Chronic Kidney Diseases

CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

Start date: August 26, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in reducing the intensity of itch in advanced chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study is comprised of an Efficacy Assessment Phase and a Long-term Extension Phase. The Efficacy Assessment Phase includes a double-blind 12-week Treatment Period (Treatment Period 1), and the Long-term Extension Phase includes a double-blind Treatment Period (Treatment Period 2) of up to 52 weeks.

NCT ID: NCT05347147 Terminated - Clinical trials for Idiopathic Intracranial Hypertension

A Trial to Determine the Efficacy and Safety of Presendin in IIH

IIH EVOLVE
Start date: November 18, 2022
Phase: Phase 3
Study type: Interventional

Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches. This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH.

NCT ID: NCT05329545 Terminated - Clinical trials for Fallopian Tube Cancer

Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)

UP-NEXT
Start date: June 23, 2022
Phase: Phase 3
Study type: Interventional

UP-NEXT is a double-blind, randomized, placebo-controlled study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks in patients with recurrent, platinum-sensitive high-grade serous ovarian cancer (HGSOC), including fallopian tube and primary peritoneal cancer, expressing high levels of NaPi2b.

NCT ID: NCT05305040 Terminated - Clinical trials for Cytomegalovirus Infections

Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

Prevent
Start date: March 24, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.

NCT ID: NCT05267574 Terminated - Clinical trials for Primary Mitochondrial Myopathy

An Open Label, Long Term Safety Study of REN001 in Primary Mitochondrial Myopathy Patients (Stride Ahead)

Start date: February 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study is designed to evaluate the long-term safety and tolerability of REN001 administered once daily to subjects with PMM due to mitochondrial DNA mutations (mtDNA-PMM) or nuclear DNA mutations (nDNA-PMM). Subjects with mtDNA mutations will have previously completed Study REN001-201 or participated in Study REN001-101. Subjects with nDNA mutations who enroll in this study will be REN001- naïve.

NCT ID: NCT05256134 Terminated - Alzheimers Disease Clinical Trials

A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)

SKYLINE
Start date: April 19, 2022
Phase: Phase 3
Study type: Interventional

A study to evaluate the efficacy and safety of gantenerumab in amyloid-positive, cognitively unimpaired participants at risk for or at the earliest stages of AD. The planned number of participants for this study is approximately 1200 participants randomized in a 1:1 ratio to receive either gantenerumab or placebo (600 participants randomized to gantenerumab and 600 participants randomized to placebo).

NCT ID: NCT05242146 Terminated - CNS Lymphoma Clinical Trials

GB5121 in Adult Patients With Relapsed/Refractory CNS Lymphoma

STAR CNS
Start date: May 24, 2022
Phase: Phase 1
Study type: Interventional

The STAR CNS trial is a 3-part study, comprising a phase 1b dose escalation, dose expansion, and a phase 2, to assess the safety, tolerability, dose-limiting toxicity(ies), maximum tolerated dose, and/or optimal biological dose, determine the recommended phase 2 dose, preliminary anti-tumor activity and efficacy of the recommended phase 2 dose of GB5121.

NCT ID: NCT05238207 Terminated - Clinical trials for Hereditary Hemochromatosis

A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers

Start date: March 28, 2022
Phase: Phase 1
Study type: Interventional

This is a first in human, double-blind, randomized, placebo-controlled, two-arm crossover study evaluating the safety, tolerability and PD of ascending dose levels of BBI-001 after: - a single administration in iron deficient male and female participants, and male and female HH patients (Part A), - two administrations per day in HH patients (Part B). BBI-001 administrations will be accompanied with consumption of a meal enriched with stable iron isotope Fe57, while corresponding placebo dose administrations will be with a meal enriched with stable iron isotope Fe58.