En studie av Lebrikizumab hos voksne deltakere med flerårig allergisk rhinitt (PREPARED-1)
En fase 3, multisenter, randomisert, dobbeltblind, placebokontrollert, parallell gruppestudie for å evaluere effektiviteten og sikkerheten til Lebrikizumab/LY3650150 hos voksne deltakere med flerårig allergisk rhinitt
The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis.
Participants can expect study participation to last up to 29.5 months.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Brussels, Belgia, 1070
- Hôpital Erasme, Service Pharmacie
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Erpent, Belgia, 5101
- Pneumocare
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Ghent, Belgia, 9000
- UZ Gent
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Leuven, Belgia, 3000
- UZ Leuven, Pharmacy
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Liège, Belgia, 4000
- Hôpital de la Citadelle
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California
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Huntington Beach, California, Forente stater, 92648
- Allergy and Asthma Specialists Medical Group
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Inglewood, California, Forente stater, 90301
- 310 Clinical Research
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Laguna Niguel, California, Forente stater, 92677
- Allergy & Asthma Associates of Southern California dba. Southern California Research
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San Diego, California, Forente stater, 92123
- Allergy and Asthma
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Colorado
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Colorado Springs, Colorado, Forente stater, 80907-6231
- Asthma and Allergy Associates, PC
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Florida
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Tallahassee, Florida, Forente stater, 32308
- Allergy and Asthma Diagnostic Center
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Tampa, Florida, Forente stater, 33613
- University of South Florida
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern University
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River Forest, Illinois, Forente stater, 60305
- Asthma Allergy Center of Chicago
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Kentucky
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Lexington, Kentucky, Forente stater, 40509
- Bluegrass Allergy Research
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Michigan
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Ypsilanti, Michigan, Forente stater, 48197
- Respiratory Medicine Research Institute of Michigan, PLC
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55402
- Clinical Research Institute
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Missouri
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Columbia, Missouri, Forente stater, 65212
- University of Missouri Hospital
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St Louis, Missouri, Forente stater, 63141
- Allergy and Asthma Consultants
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Nebraska
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Bellevue, Nebraska, Forente stater, 68123
- Asthma and Allergy Center
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New Jersey
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Belleville, New Jersey, Forente stater, 07109
- Circuit Clinical/Hudson-Essex Allergy
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Hamilton, New Jersey, Forente stater, 08619
- Circuit Clinical/Mercer Allergy and Pulmonary Associates
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Teaneck, New Jersey, Forente stater, 07666
- Dr. Patrick Perin
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New York
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Horseheads, New York, Forente stater, 14845
- Smith Allergy and Asthma
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North Carolina
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Asheville, North Carolina, Forente stater, 28803
- Allergy Partners
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Ohio
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Cincinnati, Ohio, Forente stater, 45236
- Bernstein Clinical Research Center, LLC
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Oregon
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Portland, Oregon, Forente stater, 97202
- Northwest Research Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15241
- Allergy and Clinical Immunology Associates
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Texas
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Dallas, Texas, Forente stater, 75231
- AARA Research Center
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Kerrville, Texas, Forente stater, 78028
- Kerrville Allergy and Asthma Associates
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Wisconsin
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Greenfield, Wisconsin, Forente stater, 53228
- Allergy, Asthma & Sinus Center
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Beijing, Kina, 100032
- Internal Medicine Building
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Beijing, Kina, 100730
- Department of Nasal Allergy
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Changsha, Kina, 410013
- The Third Xiangya Hospital of Central South University
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Guangzhou, Kina, 510000
- GCP Pharmacy
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Hangzhou, Kina, 310014
- Zhejiang People's Hospital
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Jingzhou, Kina, 434020
- Jingzhou Central Hospital
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Nanchang, Kina, 330006
- The First Affiliated Hospital of Nanchang University
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Nanchang, Kina, 330006
- The Second Affiliated Hospital of Nanchang University
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Nanning, Kina, 530021
- People's Hospital of Guangxi Zhuang Autonomous Region
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Nanning, Kina, 530021
- The First Affiliated Hospital of Guangxi Medical University
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Shanghai, Kina, 200065
- Tongji Hospital
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Wuhan, Kina, 430060
- Renmin Hospital of Wuhan University
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Wuhan, Kina, 430014
- Outpatient building
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Wuhan, Kina, 430022
- Outpatient Department, Union Hospital
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Yangzhou, Kina, 225001
- Northern Jiangsu People's Hospital
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Yangzhou, Kina, 225012
- Yangzhou University
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Zhongshan, Kina, 528403
- Zhongshan City People's Hospital
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Kielce, Polen, 25-355
- Polimedica PTG Kielce
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Krakow, Polen, 31-513
- Centrum Medyczne Promed ul. Olszańska 5G
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Krakow, Polen, 31-623
- Malopolskie Centrum Alergologii
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Lodz, Polen, 90-302
- gab. 114, ul. inż. pilota Wigury
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Lublin, Polen, 20-412
- ETG Lublin
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Piła, Polen, 64-920
- Centrum Alergologii Teresa Hofman Sp z.o.o.
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Rzeszów, Polen, 35-205
- EMED Centrum Usług Medycznych
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Skierniewice, Polen, 96-100
- ClinMedica Research
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Tarnów, Polen, 33-100
- Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
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Warsaw, Polen, 02-793
- ETG Warszawa
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Wroclaw, Polen, 53-201
- ALL-MED - Specjalistyczna Opieka Medyczna
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Busan, Sør -Korea, 48108
- Inje University Haeundae Paik Hospital
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Incheon, Sør -Korea, 21565
- B1F, Pharmacy department, Gachon University Gil Medical Center
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Seongnam-si, Sør -Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, Sør -Korea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Sør -Korea, 05278
- Kyunghee University Hospital at Gangdong
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Seoul, Sør -Korea, 6273
- Gangnam Severance Hospital 211
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Seoul, Sør -Korea, 7061
- SMG-SNU Boramae Medical Center
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Seoul, Sør -Korea, 8308
- Clinical trial Pharmacy
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Berlin, Tyskland, 10117
- Charité - Universitätsmedizin Berlin Klinik für Dermatologie
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Dresden, Tyskland, 1307
- Universitätsklinikum Carl Gustav Carus an der TU
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Dresden, Tyskland, 1139
- Praxis für HNO und Allergologie
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Frankfurt am Main, Tyskland, 60596
- IKF Pneumologie
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Heidelberg, Tyskland, 69115
- Siteworks - Zentrum für klinische Studien Heidelberg
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Marburg, Tyskland, 35043
- Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
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Weisbaden, Tyskland, 65183
- Zentrum für Rhinologie und Allergologie
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Physician-diagnosed perennial allergic rhinitis (PAR).
- Has a positive skin prick test (SPT) with indoor allergens and/or positive serum antigen-specific immunoglobulin E (IgE) for indoor allergens ≥0.70 kU/L, utilizing a validated assay (central laboratory).
- The participant must have clinical symptoms at study entry associated with positive perennial allergen as tested by the SPT or a positive serum antigen-specific IgE test.
- A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum antigen-specific IgE test.
- Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.
Exclusion Criteria:
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Have received a dose of lebrikizumab.
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Is currently on AIT subcutaneous immunotherapy or sublingual immunotherapy. However, individuals who discontinued subcutaneous or sublingual immunotherapy for ≥3 years prior to randomization are eligible.
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Have received treatment with any rescue medication during the run-in period.
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Have received treatment with any biologic or systemic immunosuppressants, including Janus Kinase inhibitors (JAK) for inflammatory disease or autoimmune disease prior to the baseline visit:
- Any current or prior use of biologics indicated for asthma or AD are prohibited.
- B cell-depleting biologics, including rituximab, within 6 months.
- Other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
- Systemic immunosuppressants, including JAK inhibitors, within 4 weeks prior to baseline.
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Have a history of seasonal worsening of AR and if the seasonal worsening is expected during the 4-week run-in period, the first 16 weeks after randomization, or during the last 8 weeks of the maintenance period.
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Anticipates significant changes in their daily environmental exposure.
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Has a known history of recurrent acute or chronic sinusitis.
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Female participant who is pregnant, breastfeeding or is planning to become pregnant or to breastfeed during the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)
Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS). |
Administered SC Administered as intranasal spray |
|
Eksperimentell: Lebrikizumab Q2W/every 8 weeks (Q8W)
Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS. |
Administered SC Administered as intranasal spray |
|
Placebo komparator: Placebo Q2W/Q4W
Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS. |
Administered SC Administered as intranasal spray |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
Tidsramme: Baseline, Week 16
|
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. |
Baseline, Week 16
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain at Week 16
Tidsramme: Baseline, Week 16
|
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment). |
Baseline, Week 16
|
|
Mean CFBL in RQLQ(S) Activities Domain at Week 56
Tidsramme: Baseline, Week 56
|
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment) |
Baseline, Week 56
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Mean CFBL in RQLQ(S) Total Score at Week 16
Tidsramme: Baseline, Week 16
|
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment). |
Baseline, Week 16
|
|
Mean CFBL in RQLQ(S) Total Score at Week 56
Tidsramme: Baseline, Week 56
|
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment). |
Baseline, Week 56
|
|
Mean CFBL in TNSS at Week 4
Tidsramme: Baseline, Week 4
|
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. |
Baseline, Week 4
|
|
Mean CFBL in TNSS at Week 56
Tidsramme: Baseline, Week 56
|
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. |
Baseline, Week 56
|
|
Mean CFBL in Postnasal Drip Score at Week 16
Tidsramme: Baseline, Week 16
|
Postnasal drip is mucus drainage down the throat, as part of their Allergic Rhinitis (AR), will be rated by participants using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of their postnasal drip, at its worst, for the previous 24 hours. |
Baseline, Week 16
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Sykdommer i luftveiene
- Respiratorisk overfølsomhet
- Overfølsomhet, Umiddelbar
- Overfølsomhet
- Nesesykdommer
- Otorhinolaryngologiske sykdommer
- Rhinitt
- Rhinitt, allergisk
- Rhinitt, Allergisk, Flerårig
- Health Services Administration
- Helsevesenets kvalitet, tilgang og evaluering
- Kvalitet på helsehjelpen
- Kvalitetsindikatorer, helsehjelp
- Standard for omsorg
Andre studie-ID-numre
- 18789
- J2T-MC-KGBT (Annen identifikator: Eli Lilly and Company)
- 2023-508817-18-00 (Annen identifikator: EU Clinical Trial Number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD-delingstidsramme
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Tilgangskriterier for IPD-deling
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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