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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519800-28-00 | EU Trial (CTIS) Number |
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This open label, single arm study will evaluate the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and < 18 years.
This study consists of a Dose Exploration Period and an Optional Extension Period. Eligible participants may choose to continue treatment with fenebrutinib in the optional extension period after completing the dose exploration period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenebrutinib | Experimental | Participants will receive fenebrutinib orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenebrutinib | Drug | Fenebrutinib will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Fenebrutinib | Up to Week 96 | |
| Total Number of New T1 Gadolinium (Gd)-enhancing Lesions on Brain Observed Through Magnetic Resonance Imaging (MRI) Scans | At Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to approximately 100 weeks | |
| Percentage of Participants With Suicidal Ideation (SI) or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is an interview-based instrument used to assess baseline incidence of SI and behavior. The assessment includes yes/no (0/1) responses for 5 questions, each related to SI. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: CN45847 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S.) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INECO Neurociencias Orono | Recruiting | Rosario | Santa Fe Province | S2000DTB | Argentina | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Up to approximately 100 weeks |
| Change From Baseline in Vital Signs - Pulse Rate | Baseline up to approximately 100 Weeks |
| Change From Baseline in Vital Signs - Blood Pressure | Baseline up to approximately 100 Weeks |
| Change From Baseline in Single 12-lead Electrocardiogram (ECG) Parameter - QTc Interval | Baseline up to approximately 100 Weeks |
| Change From Baseline in Single 12-lead ECG Parameter - PR Interval | Baseline up to approximately 100 Weeks |
| Change from Baseline in Clinical Laboratory Test Results - Alanine Aminotransferase (ALT) | Baseline up to approximately 100 Weeks |
| Change from Baseline in Clinical Laboratory Test Results - Aspartate Aminotransferase (AST) | Baseline up to approximately 100 Weeks |
| Sanatorio del Sur S.A. |
| Recruiting |
| San Miguel de Tucumán |
| T4000IDK |
| Argentina |
| L2IP ?Instituto de Pesquisas Clínicas Ltda. | Recruiting | Brasília | Federal District | 70200-730 | Brazil |
| Instituto de Neurologia de Curitiba - Hospital Ecoville | Recruiting | Curitiba | Paraná | 81210-310 | Brazil |
| Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR | Recruiting | Porto Alegre | Rio Grande do Sul | 90430-001 | Brazil |
| Centro de Pesquisas Clinicas - CPCLIN | Recruiting | São Paulo | São Paulo | 01228-200 | Brazil |
| Clinstile S.A de C.V. | Recruiting | Mexico City | Mexico CITY (federal District) | 06700 | Mexico |
| Neurociencias Estudios Clinicos S.C. | Recruiting | Culiacán | Sinaloa | 80020 | Mexico |
| Uniwersyteckie Centrum Kliniczne | Recruiting | Gdansk | 80 952 | Poland |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Recruiting | Poznan | 60-355 | Poland |
| Instytut "Pomnik - Centrum Zdrowia Dziecka" | Recruiting | Warsaw | 04-730 | Poland |
| Centro Clnico Acadmico - Braga, Associao (2CA-Braga) | Recruiting | Braga | 4710-243 | Portugal |
| Unidade Local de Saude de Coimbra E P E | Recruiting | Coimbra | 3000-602 | Portugal |
| Hospital Universitario de La Princesa | Recruiting | Madrid | 28006 | Spain |
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41009 | Spain |
| UH of State NPC Danulo Halytsky NMU in Lviv CID, Clinic of Neurology and Neurosurgery | Recruiting | Lviv | 79010 | Ukraine |
| ID | Term |
|---|---|
| C000619415 | fenebrutinib |
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