Clinical Trials Logo

Filter by:
NCT ID: NCT03907072 Terminated - Clinical trials for Duchenne Muscular Dystrophy

Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy

DYSTANCE 51
Start date: September 4, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension period to evaluate the safety and efficacy of WVE-210201 (suvodirsen) in ambulatory male pediatric patients with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping intervention (DYSTANCE 51)

NCT ID: NCT03905525 Completed - Sjögren Syndrome Clinical Trials

Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome

TWINSS
Start date: October 1, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.

NCT ID: NCT03904433 Completed - Aged Clinical Trials

Quantification of Ketosis After Intake of Coconut Oil and Caprylic Acid—With and Without Glucose—After a 12-hour Fast

Start date: August 24, 2018
Phase: N/A
Study type: Interventional

In a cross-over design, 15 participants, age 65-75, will be tested in six different arms in a randomised order. After a 12-hour fast participants will be served 2.5 dl coffee with 15 g cream + 30-50 g of different fatty acids, with or without 50 g glucose. Blood ketones and other biomarkers will be measured during 4 hours.

NCT ID: NCT03903835 Recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)

ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

ProBio
Start date: February 1, 2019
Phase: Phase 3
Study type: Interventional

ProBio is an international, outcome-adaptive, multi-arm, open-label, multiple assignment randomized biomarker driven platform trial in patients with metastatic prostate cancer. Patients will be randomized to control or experimental treatment arms. Patients in the control arm will receive standard of care following national guidelines. Patients in the experimental arm will be randomized to treatments based on a biomarker signature inferred from diagnostic tissue or liquid biopsy profiling. The predefined biomarker signatures are tumor properties or mutations in genes/pathways with previously demonstrated clinical validity (e.g. prognostic value or association with treatment response). The biomarker signatures are identified using a hybridisation capture gene panel specifically designed for prostate cancer.

NCT ID: NCT03903302 Completed - Thrombosis Clinical Trials

Study Investigation Pharmacokinetics and Pharmacodynamics of CS1

Start date: October 6, 2017
Phase: Phase 1
Study type: Interventional

SAD study: Eighteen subjects will be included in the SAD study (single dose) in 3 parallel arms, each with 6 subjects. The 3 arms will receive a single dose of one of the CS1 formulations I, II or III. The result of the pharmacokinetics analysis from the 6 first subjects is defined as SAD Pilot and will be used to evaluate the timing of PK sampling. Based on pharmacokinetic evaluations from all 18 subjects one of the formulations I (275 mg), II (276 mg) or III (276 mg) will be chosen to proceed into the MAD study. If none of the formulations show the desired PK properties the formulations may be re-dosed with a slightly different timing of the dose, i.e the IMP to be administered earlier or later during the evening. MAD study: Fifteen subjects will be included in a dose escalating study with 2 dose levels. The subjects will receive the lowest dose level (275 or 276 mg depending on the outcome of SAD) for the first 2 weeks before the dose is doubled (550 or 552 mg depending on the outcome of SAD) for the following 2 weeks.

NCT ID: NCT03901755 Active, not recruiting - Hemophilia B Clinical Trials

An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B

B-MORE
Start date: September 12, 2019
Phase:
Study type: Observational

Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic treatment of haemophilia B.

NCT ID: NCT03900533 Recruiting - Behavioral Symptoms Clinical Trials

Emotion Regulation Group Skills Training for Adolescents and Parents

Start date: April 2, 2019
Phase: N/A
Study type: Interventional

To evaluate if emotion regulation group therapy skills training for adolescents and parents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.

NCT ID: NCT03899155 Recruiting - Cancer Clinical Trials

Pan Tumor Rollover Study

Start date: August 9, 2019
Phase: Phase 2
Study type: Interventional

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

NCT ID: NCT03898960 Completed - Cerebral Stroke Clinical Trials

Post Marketing Study to Evaluate the NIMBUS Device

SPERO
Start date: October 30, 2019
Phase:
Study type: Observational

A post-market study evaluating the NIMBUS Device in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.

NCT ID: NCT03898687 Completed - Melanoma Clinical Trials

The Use of Magtrace®/Sentimag® in Sentinel Node Biopsy for Malignant Melanoma. The Magmen Study.

MAGMEN
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

To evaluate the use of superparamagnetic iron oxide (Magtrace®) as a tracer in sentinel node biopsy in malignant melanoma of the extremities, and to evaluate the possible role of Magtrace®-MRI for staging. Primary objective: • To evaluate if Magtrace®/Sentimag® can be used to identify SN in malignant melanoma with the same diagnostically reliability as the currently used method of Technetium 99m and Patent blue. Secondary objectives: • To evaluate if Magtrace®-MRI can predict sentinel node status in melanoma. This is a feasibility phase I, interventional single arm study. All patients included in the study will receive the same management. 20 patients will be included in the study. An enrollment time of 6-12 months is expected. Primary endpoint • To determine the detection rate of Magtrace®/Sentimag® in comparison to SNB using technetium and blue dye in patients with malignant melanoma of the extremities. Secondary endpoint • To evaluate Magtrace®-MRI sensitivity and specificity as a preoperative tool for staging in malignant melanoma.