São Luíz, Brazil
- Featured
Tours Cedex 9, Indre-et-Loire
Recruiting
- Featured
Study to evaluate HZN-825 in patients with Idiopathic Pulmonary Fibrosis (IPF)
This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety and tolerability of HZN-825 in subjects with IPF. Subjects will be screened within 8 weeks prior to the Baseline (Day 1) Visit. Approximately 360 subjects who meet the trial eligibility criteria will be randomly assigned in a 1:1:1 ratio on Day 1 to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks using the following 2 stratification factors: Prior use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no; FVC % predicted at Baseline: ≥70% or <70%.
Phase
2Span
123 weeksSponsor
Horizon Therapeutics Ireland DACTours
Recruiting
- Featured
Phase 1/2 Study Of Intratumoral G100 With Or Without Pembrolizumab or Rituximab In Patients With Follicular Non-Hodgkin’s Lymphoma
See CT.gov: **[**www.clinicaltrials.gov/ct2/show/NCT02501473**](https://www.clinicaltrials.gov/ct2/show/NCT02501473?term=G142&rank=1)**
Phase
1/2Span
Sponsor
Tours, Centre
Recruiting
Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis
Specimen will be collected at diagnosis, month 1, month 3, and month12 and at the time of a possible relapse. 14 ml of additional blood during a blood puncture made for routine care will be collected at each visit as well as clinical data.
Phase
N/ASpan
789 weeksSponsor
University Hospital, ToursTours
Recruiting
PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer
Phase
3Span
524 weeksSponsor
Institut Claudius RegaudTours
Recruiting
Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis
For both groups: At inclusion visit : - Patient information and signature of consent form - Randomisation - Previous medical history - Clinical exam - Recording ADCT, EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L Weekly during 12 months (by patients on https://hestia.chu-nantes.fr) : - Self-assessment of ADCT - Date of dupilumab injections - Batch number of dupilumab - Amount of topical corticosteroids Visits at M4, M8 and M12 will be performed for : - Clinical exam - Recording secondary end points (EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L) and adverse events - Collect out-of-pocket expenses (M4 and M12).
Phase
4Span
196 weeksSponsor
Nantes University HospitalTours
Recruiting
NAlmefene Versus Placebo in Addition to Treatment As Usual on Craving in Behavioural Addictions
Phase
3Span
227 weeksSponsor
Nantes University HospitalTours
Recruiting
Sulfasalazine in AML Treated by Intensive Chemotherapy: Elderly Patients-first Line Treatment
Phase
1/2Span
190 weeksSponsor
Assistance Publique - Hôpitaux de ParisTours
Recruiting
Assessment of the Efficacy and Safety of Alpelisib (BYL719) in Pediatric and Adult Patients with Megalencephaly-CApillary Malformation Polymicrogyria Syndrome (MCAP)
This study consists of a screening period up to 90 days, a first double-blind, placebo-controlled period of 6 months, followed by an open label period of alpelisib treatment, to reach a 24-month duration of treatment for all patients. The study will enroll 18-40 years old adults and 2-18 years old paediatric patients. Eligible patients will be randomized in a 1:1 ratio for the first period (alpelisib or placebo). A first assessment will be performed at 6 months. Patients completing this first period will enter the open label period, and either start alpelisib if they were on placebo, continue at the same dose if responders, or increase dose if not responders (dose increase only possible for children of 5 years old and over), and if no unacceptable toxicity occurs. Patients will be followed monthly in local centres, and centrally assessed (clinical, biological, neuropsychological and functional evaluation) at baseline and every 6 months. Patients will be evaluated by volumetric MRI at baseline and at 24 months. Participant may be discontinued from treatment with alpelisib earlier due to unacceptable toxicity, confirmed disease progression, death, and/or any other reason at the discretion of the investigator or the participant.
Phase
2Span
227 weeksSponsor
Centre Hospitalier Universitaire DijonTours
Recruiting