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NCT ID: NCT04105010 Completed - Clinical trials for Relapsed or Refractory Peripheral T Cell Lymphoma

Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)

Start date: September 10, 2019
Phase: Phase 2
Study type: Interventional

This is a multinational, non-randomized, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability and anti-tumor efficacy of AZD4205 as monotherapy in patients with peripheral T cell lymphoma (PTCL), who have relapsed from or are refractory/intolerant to standard systemic treatment. Phase 1 part: Around 20~40 patients will be subsequently enrolled into 2 different dose ascending cohorts. Additional 10~20 patients may be enrolled to further explore a selected dose defined by dose escalation cohorts. Phase 2 part: After the recommended phase 2 dose (RP2D) is defined, a phase 2 single-arm open-label pivotal study will be conducted to assess anti-tumor efficacy and safety of AZD4205 at RP2D in patients with refractory or relapsed PTCL.

NCT ID: NCT04103749 Completed - Clinical trials for Endoscopic Retrograde Cholangiopancreatography

Global Prospective Case Series Using a Single-Use Duodenoscope

Start date: March 22, 2021
Phase: N/A
Study type: Interventional

Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures

NCT ID: NCT04102007 Completed - Plaque Psoriasis Clinical Trials

A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab

Start date: November 12, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms. Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection at Week 0, Week 4, and then every 12 weeks for 52 Weeks (With the last dose being administered at Week 40). An additional visit will occur at Week 8 for a physical exam and questionnaire collection. A final follow-up phone call will occur at Week 60.

NCT ID: NCT04101331 Completed - Clinical trials for Peripheral T Cell Lymphoma

Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides

REDIRECT
Start date: November 13, 2019
Phase: Phase 2
Study type: Interventional

This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies. Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or have refractory disease will be enrolled into this study if all of the study entry criteria are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study participants will be assigned to one of 3 study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion). The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of overall responses. Further goals are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood. Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the patients' health status after therapy, followed by quarterly phone contacts to check on their overall health status and long-term survival.

NCT ID: NCT04098406 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS)

RESCUE-ALS
Start date: December 19, 2019
Phase: Phase 2
Study type: Interventional

The objective of this trial is to assess the efficacy, safety, and PK/PD effects of CNM-Au8 as a disease-modifying agent for the treatment of ALS by utilizing electrophysiological measures to detect preservation of motor neuron function. The primary endpoint is the mean change in the average difference between active treatment and placebo from Baseline through Week 36 evaluated by electromyography.

NCT ID: NCT04098367 Completed - Aphakia Clinical Trials

Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)

Start date: November 18, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.

NCT ID: NCT04098263 Completed - Clinical trials for Campylobacter Jejuni Infection

Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers

Start date: November 15, 2019
Phase: Phase 1
Study type: Interventional

This will be a randomized, double-blind, placebo-controlled, dose-escalation study of 3 dose levels of LMN-101. Healthy volunteers will take LMN-101 or placebo orally either as a single dose or at one of three dose levels three times daily over 28 days. Protocol-specified evaluations and procedures will be performed on Days 1-2 and every one-two weeks during dosing. Study observation will continue until 4 weeks after the last dose of study drug.

NCT ID: NCT04097769 Completed - Clinical trials for Advanced Solid Tumor

The Safety, Tolerability, and Initial Efficacy of HX009 in Patients With Advanced Malignancies

Start date: June 12, 2019
Phase: Phase 1
Study type: Interventional

This is a first-in-human, multicenter, open-label, multiple-dose Phase I study to investigate the safety, tolerability, and initial efficacy of HX009 in subjects with advanced malignant tumors. The study will consist of a dose-escalation and dose-finding component to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and to evaluate the preliminary antitumor activity of HX009.

NCT ID: NCT04093752 Completed - Type 2 Diabetes Clinical Trials

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

Start date: December 9, 2019
Phase: Phase 3
Study type: Interventional

The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.

NCT ID: NCT04093024 Completed - Clinical trials for Lung Diseases, Interstitial

A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD)

InPedILD®
Start date: December 3, 2019
Phase: Phase 3
Study type: Interventional

The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing Interstitial Lung Disease (ILD).