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NCT ID: NCT05599295 Recruiting - Clinical trials for Acute Bacterial Skin and Skin Structure Infection

Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin

Start date: June 15, 2023
Phase: Phase 2
Study type: Interventional

This protocol describes a randomized, open-label study to evaluate the safety and tolerability of single-dose intravenous (IV) oritavancin diphosphate (oritavancin) versus standard of care (SoC) antibiotics for the treatment of pediatric subjects with acute bacterial skin and skin structure infections (ABSSSIs). This study involves two oritavancin products, ORBACTIV® and KIMYRSATM. Oritavancin is the active drug substance in both ORBACTIV and KIMYRSA. This study protocol distinguishes the differences between ORBACTIV and KIMYRSA by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data, and information and guidance that is not specific to ORBACTIV or KIMYRSA (i.e., applies to both). The study involves pharmacokinetic (PK) sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to subjects and their caregivers.

NCT ID: NCT05595642 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

ARNASA
Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.

NCT ID: NCT05592496 Active, not recruiting - Postoperative Pain Clinical Trials

Bilateral Retromuscular Rectus Sheath Block Catheters Usage for Early Postoperative Analgesia After Laparotomic Gastrectomy.

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

In early postoperative period, the occurrence of severe pain after open major upper GI surgery is a significant issue. The study is aimed to access the efficiency of rectus sheet block with continuous bupivacaine infusion catheters into retromuscular space in providing an effective pain relief, decreasing opioid consumption and enhancing postoperative recovery.

NCT ID: NCT05560646 Recruiting - Endometriosis Clinical Trials

A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 to 49 With Moderate to Severe Endometriosis-related Pain

ELENA
Start date: October 25, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain.

NCT ID: NCT05557942 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)

IMPAHCT-FUL
Start date: November 2, 2022
Phase: Phase 3
Study type: Interventional

IMPAHCT-FUL: Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial is a follow up study to establish the long-term safety of AV-101. The long-term effects of AV-101 on efficacy measures will also be assessed. Subjects who successfully complete the 24-week placebo-controlled parent trial (AV-101-002) will be offered the opportunity to continue into this LTE study. Subjects who enroll in the study will receive one of three active AV-101 doses until such time as the optimal dose has been selected in the parent study.

NCT ID: NCT05536297 Active, not recruiting - Clinical trials for Age-Related Macular Degeneration

Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

Start date: September 26, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).

NCT ID: NCT05531149 Recruiting - COVID-19 Clinical Trials

Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia

TRICOVID
Start date: December 22, 2022
Phase: Phase 3
Study type: Interventional

The main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia. Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin.

NCT ID: NCT05524571 Recruiting - Thyroid Eye Disease Clinical Trials

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Start date: January 5, 2023
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.

NCT ID: NCT05518344 Terminated - Myopia Clinical Trials

Study of Viziatek ISLâ„¢ Refractive Phakic Intra Sulcus Lens for Refraction Adjustment in Blind Volunteers

Start date: June 4, 2020
Phase: N/A
Study type: Interventional

This is a clinical investigation. A total of up to 5 subjects, but not less than 3 at one investigational site will undergo insertion of the ISL in one eye and will be followed through 6 months postoperative. Subjects from the United States will not be enrolled in this study.

NCT ID: NCT05517447 Recruiting - Thyroid Eye Disease Clinical Trials

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Start date: November 6, 2023
Phase: Phase 3
Study type: Interventional

This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.