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NCT ID: NCT04200404 Completed - Clinical trials for Advanced Refractory Solid Tumors

A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

Start date: December 13, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, open-label study of CS1001 in combination with regorafenib in participants with advanced or refractory cancers. There will be a dose escalation portion in "allcomers"to find a suitable dose of regorafenib for combination use with CS1001. This study will also enroll participants with specific tumor types in the phase II part of the study to assess the efficacy, pharmacokinetics and safety of the combined regimen (RP2D of regorafenib + CS 1001)

NCT ID: NCT04198701 Completed - Atrial Fibrillation Clinical Trials

Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

PULSED AF
Start date: December 10, 2019
Phase: N/A
Study type: Interventional

The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelectâ„¢ PFA System for the treatment of atrial fibrillation (AF). The study will also provide first in human insights into clinical safety and device function of the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. To this end, the clinical study has been designed into phases (Pilot and Pivotal), with each phase comprising a separate data set that will be analyzed and reported on per the below objectives.

NCT ID: NCT04197349 Completed - Migraine Clinical Trials

Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman

Start date: September 24, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD1910, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.

NCT ID: NCT04196179 Completed - Healthy Volunteers Clinical Trials

ANG-3070 in Healthy Adult Participants

Start date: December 17, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants. This study is comprised of 12 cohorts. 5 single ascending dose (SAD) cohorts 6multiple ascending dose (MAD) cohorts, and 1 single dose food effect (FE) cross-over cohort Each cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6 subjects receiving active ANG-3070)

NCT ID: NCT04195698 Completed - Atopic Dermatitis Clinical Trials

Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

Start date: January 15, 2020
Phase: Phase 3
Study type: Interventional

This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed. Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.

NCT ID: NCT04187339 Completed - Obesity Clinical Trials

Study of NGM395 in Adult Participants

Start date: February 13, 2020
Phase: Phase 1
Study type: Interventional

Study of NGM395 in adult participants.

NCT ID: NCT04187144 Completed - Clinical trials for Urinary Tract Infections

Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)

Start date: April 23, 2020
Phase: Phase 3
Study type: Interventional

The study will be conducted to evaluate the therapeutic response (combined per participant microbiological and clinical response) of oral gepotidacin compared to oral nitrofurantoin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.

NCT ID: NCT04186481 Completed - Clinical trials for Achilles Tendon Repairs/Reconstructions

A Study of the Safety and Performance of the MINITACâ—Š Titanium 2.0 Suture Anchor

MINITAC
Start date: October 25, 2019
Phase:
Study type: Observational

This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.

NCT ID: NCT04183790 Completed - Cystic Fibrosis Clinical Trials

Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older

Start date: February 17, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF).

NCT ID: NCT04183517 Completed - Pharmacokinetics Clinical Trials

A Two-part Pharmacokinetic Study of PXS-5382A in Healthy Adult Males

Start date: December 20, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, two-part in healthy adult males. There will be up to 12 subjects with 6 subjects in each part of the study. Subjects from Part A are eligible to participate in Part B. For Part A, each of the 6 subjects will complete two periods of the study with washout period of 7 days between. Each subject during participation in the study will receive a dose of PXS 5382A orally in a fed state and a fasted state. For Part B, repeated oral BID administration of PXS-5382A will be performed in the Fed state and dose will be dependent on analysis of Part A. In both part A and B PK, PD and safety assessments will be collected.