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NCT ID: NCT04698993 Terminated - Covid19 Clinical Trials

Dräger COVID-19 Antigen Test Clinical Performance Study

Start date: February 12, 2021
Phase: N/A
Study type: Interventional

The study is designed to demonstrate suitability of the Dräger Antigen Test for SARS-CoV-2 detection in clinical nasal specimens. Real-time polymerase chain reaction (RT-PCR) on specimens collected by pharyngeal swabs serves as a reference method.

NCT ID: NCT04696354 Terminated - Venous Ulcer of Leg Clinical Trials

Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)

IGuideU
Start date: October 12, 2021
Phase: N/A
Study type: Interventional

This clinical study is a global, prospective, multi-center, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an interventional treatment guide will result in a more accurate diagnosis of deep vein occlusion (DVO), will guide optimal therapy, and will provide better clinical outcomes with reduced cost of care for patients presenting with persistent venous leg ulcers (VLUs).

NCT ID: NCT04685655 Terminated - Covid19 Clinical Trials

RescuE pLAsma eXchange in Severe COVID-19

RELAX
Start date: January 7, 2020
Phase: N/A
Study type: Interventional

The spectrum of coronavirus disease 2019 (COVID-19) ranges from asymptomatic infection to acute respiratory distress syndrome ("ARDS") and patient death. Severely affected patients may develop a cytokine storm-like clinical syndrome with high mortality. Laboratory tests in these patients show an excessive and uncontrolled immune response with consecutive multi-organ failure. In addition, there is evidence for the development of prothrombotic autoantibodies as an epiphenomenon of "Severe Acute Respiratory Syndrome Coronavirus 2" (SARS-CoV-2) infection. Therapeutic plasma exchange ("TPE") is being discussed as a therapeutic alternative in patients with severe, refractory COVID-19. The idea is that plasma exchange eliminates both endogenous and exogenous inducers of an exuberant inflammatory response as well as prothrombotic factors, thus breaking the secondary vicious circle of SARS-CoV-2 infection. In general, TPE is a safe procedure with known efficacy in other severe viral diseases as well as in cytokine storm-like diseases and ARDS of other geneses. Moreover, initial data, mostly derived from case studies, demonstrate promising therapeutic efficacy of TPE in severe COVID-19 courses with previously lacking treatment options. To further evaluate the therapeutic efficacy of TPE in severe COVID-19, a prospective randomized controlled trial of TPE in severe SARS-CoV-2 infection is being conducted at our center. Patients will be randomized to a control group (standard therapy according to center standards) and a therapy/intervention group (standard therapy + TPE).

NCT ID: NCT04684914 Terminated - Clinical trials for Hepatitis B, Chronic

HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)

Start date: December 26, 2020
Phase: Phase 2
Study type: Interventional

A study to evaluate the antiviral effects, immunogenicity, and safety of HepTcell in treatment-naive patients with inactive Chronic Hepatitis B (CHB) and low Hepatitis B surface antigen (HBsAg) levels.

NCT ID: NCT04684654 Terminated - Clinical trials for Healthy Participants

BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome

Start date: February 16, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986325 in healthy participants and participants with primary Sjögren's syndrome. The results will guide the future clinical development with BMS-986325.

NCT ID: NCT04661033 Terminated - Clinical trials for Warm Autoimmune Hemolytic Anemia (wAIHA)

Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)

Start date: September 9, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objectives: - Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA - Part B: To evaluate the efficacy of the selected dose in adults with wAIHA Secondary Objectives: - Part A (Cohorts 2 and 3 only) - To evaluate the efficacy of isatuximab in adults with wAIHA - To evaluate the durability of response to isatuximab and time to response - To evaluate the impact of isatuximab treatment on fatigue Part B - To evaluate the safety and tolerability of isatuximab in adults with wAIHA - To evaluate the durability of response to isatuximab and time to response - To evaluate the impact of isatuximab treatment on fatigue Parts A (all Cohorts) and B - To evaluate the effect of isatuximab on markers of hemolysis - To characterize the pharmacokinetic profile of isatuximab in adults with wAIHA - To evaluate the immunogenicity of isatuximab

NCT ID: NCT04658095 Terminated - Clinical trials for Glaucoma, Open-Angle

Study of OMNI Surgical System and iStent for Eyes With OAG (Trident)

Start date: December 14, 2021
Phase: N/A
Study type: Interventional

First, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the OMNI Surgical System to implantation of the iStent inject in lowering intraocular pressure (IOP) in pseudophakic eyes with open angle glaucoma (OAG), and second, to compare safety and effectiveness outcomes for canaloplasty alone (using the OMNI Surgical System)to implantation of the iStent Inject in lowering IOP in pseudophakic eyes with OAG.

NCT ID: NCT04655911 Terminated - Clinical trials for Mucopolysaccharidosis III-B

A Long-term Follow-up Study of Patients With MPS IIIB Treated With ABO-101

Start date: October 28, 2020
Phase:
Study type: Observational

This is a multicenter, non-interventional, long-term follow-up (LTFU) study in participants who have been treated with ABO-101 in a prior trial. Eligible participants will undergo clinical evaluations at prespecified intervals for 3 years from the last visit in the prior clinical trial (up to 5 years post-treatment).

NCT ID: NCT04649060 Terminated - Clinical trials for Relapsed Multiple Myeloma

Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma

LIGHTHOUSE
Start date: December 21, 2020
Phase: Phase 3
Study type: Interventional

This was a randomized, controlled, open-label, Phase 3 multicenter study which enrolled patients with Relapsed-Refractory Multiple Myeloma (RRMM) who were either double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI) (regardless of the number of prior lines of therapy), or had received at least 3 prior lines of therapy including an IMiD and a PI. Patients received treatment with melflufen+dexamethasone+daratumumab or daratumumab until documented progressive disease, unacceptable toxicity, or patient/treating physician decision. Patients in the daratumumab treatment arm had the option to receive treatment with melflufen+dexamethasone+daratumumab after confirmed progressive disease.

NCT ID: NCT04648020 Terminated - Clinical trials for Chemoradiotherapy-Induced Severe Oral Mucositis

Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer.

VOICE
Start date: February 11, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study is being performed to evaluate the effectiveness of a new drug, clonidine HCl MBT, to prevent the onset of severe oral mucositis (SOM) in patients with oropharyngeal cancer (OPC) who are being treated with chemoradiotherapy. OPC occurs on the back of the tongue or throat and is often treated by the use of chemoradiotherapy, where radiation is localized to these areas. Radiation to the OPC affected tissues causes the release of small proteins called cytokines that cause damage to the area surrounding the tumor including the oral cavity. This damage is characterized by the formation of mucositis which includes redness, pain and ulcers in the mouth and back of the throat. In addition, as more chemoradiation is administered to treat OPC, the inability to eat a solid diet (a Grade 3 mucositis) or to consume anything at all by mouth (a Grade 4 mucositis) occurs in many patients. Collectively, Grade 3 and Grade 4 mucositis is referred to as SOM. It is a frequent, debilitating side effect of chemoradiation in OPC that may cause patients to stop or interrupt their treatment, develop other side effects like the inability to swallow, or require the increased use of pain medications. OPC survivors who have successful treatment of their tumors often develop permanent swallowing, speaking and range of motion issues that may be linked back to the inability to eat and/or drink caused by SOM during their chemoradiotherapy treatment. Clonidine may inhibit the production of cytokines that cause SOM and clonidine HCl mucoadhesive buccal tablet (MBT) has been designed to deliver sustained high levels of clonidine in the oral cavity, potentially decreasing cytokine production and leading to a decrease in the incidence of SOM. Clonidine HCl MBT is a once per day treatment provided as a tablet that a patient may self-administer to the gums, where it sticks tightly to release clonidine over many hours. The primary objective of this Phase 2b/3 study is to evaluate whether clonidine HCl MBT is more effective than placebo MBT in decreasing the incidence of SOM.