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NCT ID: NCT04824794 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies

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

The drug that will be investigated in the study is an antibody, GEN3014. Since this is the first study of GEN3014 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN3014 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN3014. GEN3014 will be studied in relapsed or refractory multiple myeloma (also known as RRMM) and other blood cancers. The study consists of 3 parts: 1. The Dose Escalation will test increasing doses of GEN3014 to find a safe dose level to be tested in the other two parts. 2. Expansion Part A will further test the GEN3014 dose determined from the Dose Escalation Part. 3. Expansion Part B will compare intravenous (IV) GEN3014 with the subcutaneous (SC) daratumumab in ex-US countries. Participants will receive either GEN3014 or daratumumab; none will be given placebo. The study duration will be different for the individual participants. Overall, the study may be ongoing up to 5 years after the last participant's first treatment.

NCT ID: NCT04821310 Recruiting - Esophagitis Clinical Trials

Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years

Start date: January 13, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.

NCT ID: NCT04818671 Active, not recruiting - Clinical trials for Generalized Myasthenia Gravis

Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis

ADAPTSC+
Start date: April 26, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection. Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment periods Health measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).

NCT ID: NCT04814108 Suspended - Clinical trials for Uterine Serous Carcinoma

A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma

Start date: July 28, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study to evaluate the clinical activity and safety of ZN-c3 (azenosertib) in adult women with recurrent or persistent uterine serous carcinoma (USC).

NCT ID: NCT04813731 Recruiting - Covid19 Clinical Trials

COVID-19 And Lingering Symptoms In Primary Care Patients

CALIP
Start date: December 12, 2020
Phase:
Study type: Observational

The ongoing corona virus disease 2019 (COVID-19) is a viral acute respiratory tract infection caused by server acute respiratory syndrom coronavirus typ 2 (SARS-CoV-2). The signs and symptom of SARS-CoV-2 infection vary and most people with COVID-19 experience illness of mild or moderate severity and recover with symptomatic treatment outside of hospital. Studies have found that some people experience lingering/long-lasting symptoms and only a minority of patients were completely free from COVID-19 related symptoms after two months. About one third still had up to two residual symptoms and 55% had three or more. As far as we know no study on lingering symptoms has been published in patients after a mild or moderate infection managed in primary care settings. The aim of this study is to explore the course of disease over a one year period and describe lingering symptoms and their impact on well-being and daily activities in adult non-hospitalized patients with previous established COVID-19 infection.

NCT ID: NCT04812925 Active, not recruiting - Clinical trials for Primary Immune Thrombocytopenia

A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

ADVANCE SC+
Start date: November 17, 2021
Phase: Phase 3
Study type: Interventional

A Phase 3 study to evaluate the safety and efficacy of efgartigimod PH20 subcutaneous in adult patients with primary immune thrombocytopenia

NCT ID: NCT04807283 Active, not recruiting - Atrial Fibrillation Clinical Trials

Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System

Start date: March 5, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism from the left atrial appendage (LAA).

NCT ID: NCT04799249 Active, not recruiting - Breast Cancer Clinical Trials

Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)

PRESERVE 2
Start date: April 15, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or second-line treatment for locally advanced unresectable/metastatic TNBC.

NCT ID: NCT04795557 Completed - Covid19 Clinical Trials

Efficacy of Adaptogens in Patients With Long COVID-19

Start date: April 19, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this clinical trial of a fixed combination of standardized extracts from Rhodiola rosea roots, Schisandra chinensis berry and Eleutherococcus senticosus root (ADAPT-232) in COVID-19 patients is to demonstrate possible efficacy of adjuvant treatment with ADAPT-232 in decreasing the duration of the convalescence, alleviation of fatigue, headache, attention deficit, difficult and rapid respiration, depression, anxiety and other symptoms of Long COVID-19 during rehabilitation period.

NCT ID: NCT04792385 Completed - Safety Clinical Trials

Safety, Compliance and Pharmacokinetics of Estetrol Monohydrate/Drospirenone 15/3 mg in Post-menarchal Female Adolescents

Start date: December 28, 2020
Phase: Phase 3
Study type: Interventional

To evaluate the safety, compliance, and pharmacokinetics profile of estetrol monohydrate (E4) 15 mg combined with drospirenone (DRSP) 3 mg in post-menarchal participants between the age of 12 and 17 years + 2 months.