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NCT ID: NCT04431726 Active, not recruiting - Severe Hemophilia A Clinical Trials

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Participants From Birth to 12 Months of Age With Hemophilia A Without Inhibitors

HAVEN 7
Start date: February 4, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase IIIb, multicenter, open-label, single-arm study of prophylactic emicizumab in previously untreated and minimally treated patients at study enrollment from birth to ≤12 months of age with severe hemophilia A (intrinsic factor VIII [FVIII] level <1%) without FVIII inhibitors. The study is designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab administered at 3 milligrams per kilogram of body weight (mg/kg) once every 2 weeks (Q2W) for 52 weeks. After 1 year of treatment, participants will continue to receive emicizumab (1.5 mg/kg once every week [QW], 3 mg/kg Q2W or 6 mg/kg once every 4 weeks [Q4W]) over a 7-year long-term follow-up period under this study frame.

NCT ID: NCT04431674 Completed - Breast Cancer Clinical Trials

Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients With Chest-wall and Breast Cancer

USmBRT-B
Start date: July 22, 2020
Phase: Phase 1
Study type: Interventional

The objective of this study is to demonstrate the feasibility of novel MRI-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device.

NCT ID: NCT04431648 Recruiting - Clinical trials for Head and Neck Cancer

Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients With Head and Neck Cancer

USmBRT-H
Start date: May 1, 2020
Phase: Phase 1
Study type: Interventional

The objective of this study is to demonstrate the feasibility of novel MRI-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device.

NCT ID: NCT04431479 Recruiting - Clinical trials for Chronic Graft Versus Host Disease

Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study

Start date: June 29, 2020
Phase:
Study type: Observational

This trial collects clinical data and blood samples to predict the quality of response to specific treatments in patients with chronic graft-versus-host disease (cGVHD) who are about to start initial or second-line therapy. Collecting and analyzing clinical data and blood samples from patients with cGVHD before and after treatment initiation may help doctors identify changes that may predict treatment response.

NCT ID: NCT04430855 Completed - Clinical trials for Hidradenitis Suppurativa (HS)

A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms

Start date: July 14, 2020
Phase: Phase 2
Study type: Interventional

Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal and genital) regions. This study will evaluate how well upadacitinib compared to placebo (no medicine) works to treat hidradenitis suppurativa in adult participants with moderate to severe disease. The study will assess change in disease signs and symptoms.

NCT ID: NCT04430790 Recruiting - Clinical trials for Respiratory Insufficiency

Doxapram Therapy in Preterm Infants (DOXA Trial)

Start date: June 15, 2020
Phase: Phase 3
Study type: Interventional

Preterm infants often suffer from apnea of prematurity (AOP; a cessation of breathing) due to immaturity of the respiratory system. AOP can lead to oxygen shortage and a low heart rate which might harm the development of the newborn, especially the central nervous system. In order to prevent oxygen shortage, infants are treated with non-invasive respiratory support and caffeine. Despite these treatments, many preterm newborns still suffer from AOP and need invasive mechanical ventilation. Although this will result in complete resolution of AOP, invasive mechanical ventilation has the disadvantage of being a major risk of chronic lung disease and impaired neurodevelopmental outcome. Restrictive invasive ventilation is therefore advocated nowadays in preterm infants. Doxapram is a respiratory stimulant that has been administered off-label to treat AOP. Doxapram, as add-on treatment, seems to be effective in treating AOP and to prevent invasive mechanical ventilation. It is unclear if a preterm infant benefit from doxapram treatment on the longer term. This study compares doxapram to placebo and hypothesizes that doxapram will protect preterm infants from both invasive ventilation (and related lung disease) and AOP related oxygen shortage (and related impaired brain development).

NCT ID: NCT04430569 Recruiting - Pulmonary Embolism Clinical Trials

Pulmonary Embolism International THrOmbolysis Study-3

PEITHO-3
Start date: August 4, 2021
Phase: Phase 3
Study type: Interventional

In this study, we will assess the efficacy and safety of a reduced dose of thrombolytic therapy given in addition to low-molecular-weight heparin in patients with intermediate-high-risk acute pulmonary embolism. Half of participants will receive thrombolytic treatment, while the other half will receive a placebo.

NCT ID: NCT04429542 Recruiting - Colorectal Cancer Clinical Trials

Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors

Start date: June 1, 2020
Phase: Phase 1
Study type: Interventional

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

NCT ID: NCT04429503 Active, not recruiting - Clinical trials for Type 2 Diabetes Mellitus

Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease

PHOTON
Start date: June 29, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks. The secondary objectives of the study are as follows: - To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response - To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept

NCT ID: NCT04428944 Recruiting - Atrial Fibrillation Clinical Trials

STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation

STARAF3
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF: 1. PV antral isolation alone (PVAI) 2. PV antral isolation plus ablation of drivers (PVAI+drivers) 3. PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.