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Genetic Diseases, Inborn clinical trials

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NCT ID: NCT04399694 Suspended - Genetic Disease Clinical Trials

Identification and Characterization of Novel Non-Coding Variants That Contribute to Genetic Disorders

Start date: March 3, 2020
Phase:
Study type: Observational

The goal of this study is to identify and characterize novel non-coding and splicing variants that may contribute to genetic disorders. We will particularly focus on patients with a diagnosed genetic disorder that has inconclusive genetic findings.

NCT ID: NCT04307719 Completed - Clinical trials for Genetic Predisposition

Prevalence of Carriers of Genetic Diseases in the Mexican Jewish Community

Start date: July 1, 2020
Phase:
Study type: Observational [Patient Registry]

The Jewish Population is at an increased risk for genetic diseases, especially autosomal recessive, thus, screening should be done to determine carrier status of several genetic diseases. In the Mexican Jewish Community, which is a very diverse community (regarding geographical origins), data of carrier status is unknown. The study aims to determine carrier prevalence for over 300 diseases using commercially available panels.

NCT ID: NCT04285814 Recruiting - Genetic Disease Clinical Trials

Technology Development for Noninvasive Prenatal Genetic Diagnosis Using Whole Fetal Cells From Maternal Peripheral Blood

Start date: September 1, 2020
Phase:
Study type: Observational

Amniocentesis (amnio) and chorionic villus sampling (CVS) can reliably detect many smaller DNA/genetic abnormalities that cannot be reliably diagnosed by cell-free noninvasive prenatal testing (NIPT) that is in widespread use. The investigators present evidence that a cell-based form of NIPT, here called Single Fetal Cell (SFC) testing, using a blood sample from the mother can detect most or all of the genetic abnormalities that are detected using amnio or CVS. This study proposes to compare the effectiveness of SFC testing in detecting abnormalities already detected by amnio or CVS in women already undergoing these tests as part of their clinical care because of fetal ultrasound abnormalities.

NCT ID: NCT04248504 Not yet recruiting - Genetic Disease Clinical Trials

Digital Genetic Assistant (DGA) for Expanded Carrier Screening

Start date: February 1, 2020
Phase:
Study type: Observational

The DGA provides an end-to-end digital solution to the preconception carrier screening process from participant registration to receipt of the test results and their interpretations. These steps are provided using personalized animated videos.

NCT ID: NCT04208529 Enrolling by invitation - Sickle Cell Disease Clinical Trials

A Long-term Follow-up Study in Participants Who Received CTX001

Start date: January 20, 2021
Phase: Phase 3
Study type: Interventional

This is a multi-site, open- label rollover study to evaluate the long-term safety and efficacy of CTX001 in pediatric and adult participants who received CTX001 in parent studies 111 (NCT03655678) 141 (NCT05356195) or 161 (NCT05477563) (transfusion-dependent β-thalassemia [TDT] studies) or Study 121 (NCT03745287) or 151 (NCT05329649), 161(NCT05477563),171 (NCT05951205) (severe sickle cell disease [SCD] studies).

NCT ID: NCT04157595 Active, not recruiting - Clinical trials for Autosomal Recessive Disorder

Mackenzie's Mission: The Australian Reproductive Carrier Screening Project

Start date: November 21, 2019
Phase: N/A
Study type: Interventional

This study will investigate reproductive genetic carrier screening (RGCS) in 10,000 couples across Australia. Carrier screening for approximately 1300 genes associated with severe, childhood-onset, X-linked and autosomal recessive conditions will be performed on each member of the couple. A combined result will be issued indicating whether the couple has a 'low' or 'increased' risk of having a child with a genetic condition. It is anticipated that 1-2% of couples will be at an increased risk of having an affected child. The study will evaluate all aspects of the RGCS program to assess the feasibility and acceptability of a publicly-funded population-wide RGCS program, including: - education of recruiting healthcare providers - education of participating couples - implementation and uptake of RGCS - frequency of increased-risk couples and their reproductive decisions - psychosocial impacts - ethical issues - health economic implications - health implementation research

NCT ID: NCT04152876 Not yet recruiting - Rare Diseases Clinical Trials

Functional Genomics of Rare Genetic Diseases: Realization of Innovative Tools With High Diagnostic Power

Start date: October 31, 2019
Phase:
Study type: Observational

The project aims to improve the understanding of a significant group of rare diseases both from a genetic/diagnostic and clinical/experimental point of view and aims to develop one or more diagnostic protocols. The study will be conducted through the application of complementary experimental strategies, ranging from the clinical, genetic and molecular characterization of the pathology to the search for rare variants and the development of cellular disease models.

NCT ID: NCT04123626 Active, not recruiting - Eye Diseases Clinical Trials

A Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects With Autosomal Dominant Retinitis Pigmentosa Due to the P23H Mutation in the RHO Gene

AURORA
Start date: October 7, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates the safety, tolerability and efficacy of QR-1123 injection in the eye (intravitreal; IVT) injections (one eye/unilateral) in subjects receiving a single dose or repeat doses. Single injections will be assessed in an open label way, and repeat injections will be assessed in a double-masked, randomized, sham-controlled fashion.

NCT ID: NCT04069260 Terminated - Genetic Disease Clinical Trials

A Phase 2 Study of ELX-02 in Patients With Nephropathic Cystinosis

Start date: August 2, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2 open label study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 in patients with cystinosis with nonsense mutation in at least one allele. Six patients will be enrolled in the trial. The study will comprise of the following periods for each patient: - A screening period of up to 6 weeks - A total treatment period of 4 weeks - A safety follow-up period of 4 weeks after the last treatment Each patient will receive three escalating doses as follows: - Treatment period 1: ELX-02 0.5 mg/kg SC daily for 7 days (total dose not to exceed 3.5 mg/kg for this week; the daily dose will be individualized to achieve the target weekly exposure of about 47.5 µg*h/mL) - Treatment period 2: ELX-02 1.0 mg/kg SC daily for 7 days (total dose not to exceed 7.0 mg/kg for this week; the daily dose will be individualized to achieve the target weekly exposure of about 95 µg*h/mL) - Treatment period 3: ELX-02 2.0 mg/kg SC daily for 14 days (total dose not to exceed 14 mg/kg for these two weeks; the daily dose will be individualized to achieve the target weekly exposure of about 190 µg*h/mL)

NCT ID: NCT04042402 Enrolling by invitation - Kidney Diseases Clinical Trials

Long Term Extension Study in Patients With Primary Hyperoxaluria

PHYOX3
Start date: July 9, 2019
Phase: Phase 3
Study type: Interventional

The proposed study is designed to provide patients previously enrolled in Phase 1 and 2 studies of DCR-PHXC and their siblings (<18 years old) long-term access to DCR-PHXC, and to evaluate the long-term safety and efficacy of DCR-PHXC in patients with PH.