Clinical Trials Logo

Filter by:
NCT ID: NCT03347422 Completed - Clinical trials for Cold Agglutinin Disease

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion

Cadenza
Start date: March 17, 2018
Phase: Phase 3
Study type: Interventional

The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=)1.5 grams per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.

NCT ID: NCT03347396 Completed - Clinical trials for Agglutinin Disease, Cold

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)

Start date: March 5, 2018
Phase: Phase 3
Study type: Interventional

The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to >= 12 g/dL and obviated the need for blood transfusion during treatment in participants with primary cold agglutinin disease (CAD) who had a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with CAD.

NCT ID: NCT03347344 Completed - Clinical trials for Spinocerebellar Ataxia Type 2

Clinical Trial With Riluzole in Spinocerebellar Ataxia Type 2 (ATRIL)

ATRIL
Start date: January 17, 2018
Phase: Phase 3
Study type: Interventional

ATRIL is a multi-centric, double-blind randomized, two-arm controlled study. 42 SpinoCerebellar Ataxia type 2 (SCA2) patients, both gender, at least 18 years of age will be included. Riluzole 50 mg will be administered (per os) twice a day, versus one group with placebo for 12 months. Riluzole (Rilutek®) is a benzothiazole drug, market approved, for Amyotrophic Lateral Sclerosis (ALS). It delays the onset of ventilator-dependence or tracheostomy in selected patients and may increase survival. Scale for the Assessment and Rating of Ataxia (SARA) will be used at M0, M6 and M12. To assess primary criterion, the percentage of patients with a decrease of at least 1 point of the SARA score between the inclusion visit, and Visit 3 (Months 12) will be calculated.

NCT ID: NCT03347331 Completed - Healthy Subjects Clinical Trials

[18F]-F13640 as a New Brain Radiopharmaceutical

F13640
Start date: April 23, 2018
Phase: Early Phase 1
Study type: Interventional

This clinical assay is designed to validate that [18F]F13640 as a radiotracer of 5-HT1A functional receptors. A first group of healthy subjects underwent a PET scan with arterial blood sampling to determine the kinetic model of the tracer. A second group of healthy subjects underwent a classical test-retest study (i.e two distant PET scans) to determine the reproducibility of measures.

NCT ID: NCT03347279 Completed - Asthma Clinical Trials

Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma

NAVIGATOR
Start date: November 23, 2017
Phase: Phase 3
Study type: Interventional

A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma

NCT ID: NCT03346954 Completed - Cushing's Disease Clinical Trials

Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease

IMPEC
Start date: December 11, 2017
Phase: N/A
Study type: Interventional

Cushing's disease is characterized by the existence of a benign pituitary tumor developed from corticotropic cells responsible for excessive ACTH secretion. This results in hypercorticism causing high morbidity and mortality and severely impairing quality of life. The etiological diagnosis is based on Magnetic Resonance Imaging (MRI). However, pituitary MRI revealed a pituitary tumor in only 60% of patients. The diagnostic procedure is complicated by the existence of extra pituitary tumors responsible for ACTH ectopic secretion. This rare etiology imposes, in the absence of typical pituitary image, the realization of catheterization of the lower petrosal sinuses. Treatment of Cushing's disease is based on transsphenoidal surgical management, even in the absence of a formal MRI image, if pituitary origin is confirmed by the catheterization. Although pituitary surgery without identified target is part of French recommendations, this surgery is associated with a high risk of failure and morbidity. Optimization of the management of patients' with Cushing's disease thus requires the improvement of the diagnostic methods. Hypothesis of our study is that [11C] MET MRI-PET may be performed as a first-line MRI for suspected Cushing's disease and may limit indications for catheterization of lower petrosal sinuses. Its localizing value should also make it possible to improve the surgical results with a better identification of the adenoma

NCT ID: NCT03346941 Completed - Chronic Hepatitis c Clinical Trials

Side Effects After Direct-acting Antiviral Treatment

EFINO-C
Start date: May 1, 2016
Phase: N/A
Study type: Observational

The objective of this study was to assess the incidence of side effects after direct-acting antiviral therapy in patients with chronic hepatitis C virus infection.

NCT ID: NCT03346928 Completed - Clinical trials for Head and Neck Cancer

Free Flaps : Should we Propose Them to the Elderly ?

Start date: October 1, 2012
Phase: N/A
Study type: Observational

The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction.

NCT ID: NCT03346408 Completed - Pain, Chronic Clinical Trials

Dependence on Analgesics in Chronic Non-cancer Pain

DISCORDANCE
Start date: November 4, 2017
Phase:
Study type: Observational

The identification of an addiction to opioid analgesics has become strong recommendation for the purpose of improving the clinical management of the patients. However, the success of the patient's clinical management, in terms of analgesia and treatment of drug dependence, rests on the acceptance of this management by the patient himself. The main objective of this study is to evaluate the factors associated to the discrepancy between the assessment of dependence on analgesic drugs by the algologist and the perception that the patient with non-cancer chronic pain has of this dependence.

NCT ID: NCT03345849 Completed - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

U-EXCEL
Start date: December 7, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).