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NCT ID: NCT04941183 Terminated - Covid19 Clinical Trials

Phase 1 Study to Assess Safety, Tolerability, PD, PK, Immunogenicity of IV NTR-441 Solution in Healthy Volunteers and COVID-19 Patients

Start date: April 14, 2021
Phase: Phase 1
Study type: Interventional

This first-in-human clinical study is a Phase 1a/ 1b, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and PK/PD of NTR-441 in healthy subjects and patients with COVID-19 after single ascending IV infusion doses and multiple ascending IV infusion doses.

NCT ID: NCT04913675 Terminated - Covid19 Clinical Trials

Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.

Start date: June 10, 2021
Phase: Phase 3
Study type: Interventional

The COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19. In the safety substudy, the aim was to evaluate the safety and tolerability of sotrovimab across a single ascending dose level and over different infusion times when given for the treatment of mild/moderate COVID-19 to participants at high risk of disease progression Main study was completed successfully. The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.

NCT ID: NCT04889040 Terminated - COVID-19 Clinical Trials

Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19

MORNINGSKY
Start date: April 28, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.

NCT ID: NCT04888585 Terminated - Clinical trials for Rheumatoid Arthritis (RA)

Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)

Start date: June 2, 2021
Phase: Phase 2
Study type: Interventional

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active RA. Adverse events and change in the disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of RA. Study doctors place the participants in 1 of 5 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. Participants 18-75 years of age with moderate to severe RA will be enrolled. Around 425 participants will be enrolled in the study in approximately 270 sites worldwide. The study is comprised of a 12-week placebo-controlled period, a double-blind long-term extension (LTE) period 1 of 66 weeks, a LTE period 2 of 104 weeks and a follow-up visit 70 days after the last dose of the study drug. In the LTE period 1, participants in the placebo group will be re-randomized to receive ABBV-154 in 2 different doses SC every other week (eow). Other participants will remain on their previous dose and dosing regimen of ABBV-154. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT04869943 Terminated - Clinical trials for Metastatic Breast Cancer

Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer

ARTEST
Start date: October 12, 2021
Phase: Phase 3
Study type: Interventional

To demonstrate the efficacy of enobosarmin the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS).

NCT ID: NCT04859517 Terminated - COVID-19 Clinical Trials

Evaluation of ADG20 for the Prevention of COVID-19

EVADE
Start date: April 27, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This placebo-controlled study is intended to evaluate ADG20's safety and ability to prevent COVID-19 infection.

NCT ID: NCT04847440 Terminated - Clinical trials for Hepatitis B, Chronic

A Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection

Start date: March 30, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blinded, placebo-controlled, multi center, dose ranging study of safety and efficacy in both volunteers with chronic hepatitis B virus infection and in volunteers with hepatitis D virus coinfection. Volunteers will be administered multiple oral doses of ATI-2173 and assessed for safety and efficacy including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the drug effects the virus infection.

NCT ID: NCT04847232 Terminated - Hyperkalemia Clinical Trials

Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)

Start date: April 30, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC) on arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.

NCT ID: NCT04805671 Terminated - COVID-19 Clinical Trials

Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19

STAMP
Start date: July 26, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This placebo controlled study is intended to generate safety and efficacy data in order to provide a treatment option for COVID-19 in patients with a high risk of disease progression based on age or co-morbid medical conditions.

NCT ID: NCT04783727 Terminated - Clinical trials for Bacterial Infections

PredictEndTB Signature for Individualizing Treatment in Multidrug-Resistant Tuberculosis

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

PredictEndTB signature is a non-inferiority, prospective, parallel-group open-label randomized controlled trial evaluating the efficacy of individualised antituberculous treatment durations that utilize the transcriptomic signature-based model compared to the standardised twenty months treatment in a cohort of multidrug-resistant tuberculosis patients.