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NCT ID: NCT04559425 Recruiting - Clinical trials for Heart Block Second Degree

Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block

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

Few studies are specifically designed to address health concerns that are already relevant during pregnancy. The consequence is a lack of evidence on best clinical practice. This includes mothers and their babies when pregnancy is complicated by an abnormally slow heart rate due to maternal antibody-mediated heart disease in the unborn baby (fetus). Since the late seventies, it has been possible to detect and monitor fetal disease by ultrasound images and to treat selected conditions with pharmaceuticals administered via the mother. To this day, physicians need to make decisions about the management of such pregnancies without evidence from prospective clinical trials on drug efficacy and safety. The SLOW HEART REGISTRY is a multi-centered prospective observational study that will address the knowledge gap to guide future management of high-degree immune-mediated heart block to the best of care. The study seeks to establish an international database of the management and outcome of affected fetuses, to be used to publish information on the results of currently available prenatal care and to evaluate the need for additional research.

NCT ID: NCT04559126 Completed - Clinical trials for NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis

A Study of EDP-297 in Healthy Subjects

Start date: September 8, 2020
Phase: Phase 1
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.

NCT ID: NCT04558918 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment

APPLY-PNH
Start date: January 25, 2021
Phase: Phase 3
Study type: Interventional

This study was a multi-center, randomized, open-label, active comparator-controlled, parallel group study. The purpose of this Phase 3 study in PNH patients presenting with residual anemia despite treatment with anti-C5 antibody, was to determine whether iptacopan is efficacious and safe for the treatment of PNH through demonstration of superiority of iptacopan compared to anti-C5 antibody treatment.

NCT ID: NCT04557800 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers

Start date: November 16, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), multiple ascending dose (MAD), and 28-day safety study of orally administered DNL151 in healthy volunteers.

NCT ID: NCT04557462 Recruiting - Clinical trials for Primary IgA Nephropathy

A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

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

The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.

NCT ID: NCT04557098 Active, not recruiting - Clinical trials for Hematological Malignancies

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

MajesTEC-1
Start date: September 17, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

NCT ID: NCT04556682 Completed - Clinical trials for Coronary Calcification

IVL and RA in Treatment of Balloon-crossable Severely Calcified Coronary Lesions

Start date: May 1, 2021
Phase:
Study type: Observational

This study to compare periprocedural safety, angiographic success as well as short and long term outcomes of intravascular lithotripsy and rotational atherectomy as a method of severely calcified coronary lesion preparation before DES implantation.

NCT ID: NCT04556656 Active, not recruiting - Huntington Disease Clinical Trials

PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD

Start date: October 16, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).

NCT ID: NCT04555967 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

SAPIEN 3 Ultra System PMCF

Start date: June 30, 2020
Phase:
Study type: Observational

A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.

NCT ID: NCT04555486 Completed - Clinical trials for Primary Hyperoxaluria Type 3

Study to Evaluate Safety, Tolerability, PK and PD of DCR-PHXC in PH Type 3 Patients

PHYOX4
Start date: September 14, 2020
Phase: Phase 1
Study type: Interventional

The DCR-PHXC-104 study is designed to assess the safety, tolerability, and pharmacological parameters of a single dose of DCR-PHXC in Primary Hyperoxaluria Type 3 (PH3). Participants should have had at least one stone event within 12 months of screening and intact renal function.