A Study of Patients' Preferences for Primary Immune Thrombocytopenia Treatment
Patients' Preferences for Primary Immune Thrombocytopenia Treatment
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
This is a non-interventional study to assess treatment preferences from patients with ITP. Data will be collected from participants using a preference elicitation survey.
The study consists of two stages. Stage 1 includes the development of the survey and identification of key treatment attributes. Stage 2 involves administration of the finalized survey, followed by comprehensive analysis of the data to assess treatment preferences.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Novartis Pharmaceuticals
- Telefonnummer: +41613241111
- E-post: novartis.email@novartis.com
Studera Kontakt Backup
- Namn: Novartis Pharmaceuticals
Studieorter
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New Jersey
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East Hanover, New Jersey, Förenta staterna, 07936
- Rekrytering
- Novartis
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion criteria:
- Currently living in the US.
- Aged 18 years and older on the day of providing informed consent.
A diagnosis of primary ITP:
a. For participants receiving first-line (1L) treatment for ITP: i. Diagnosed with primary ITP and started 1L corticosteroids within 3 months of diagnosis ii. Responded to 1L corticosteroid treatment [with or without intravenous immunoglobulin (IVIg)] b. For participants receiving second-line (2L) treatment for ITP: i. Assessed as needing or are taking thrombopoietin receptor agonist (TPO-RA) treatment for 2L treatment ii. Has previously been treated with a 1L corticosteroid (with or without IVIg) with insufficient response or relapse
Exclusion criteria:
- For participants receiving 1L treatment for ITP only: Previous or current use of treatments different from corticosteroids and/or IVIg/anti-D immunoglobulin.
- For participants receiving 2L ITP treatment: Previous or current use of treatments different from corticosteroids, IVIg/anti-D immunoglobulin or one TPO-RA (i.e. patients who have used any treatment in a third-line setting are ineligible).
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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ITP Cohort
Adults with ITP in the US who are being treated in either 1L or 2L settings.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Preference Weights for Treatment Attributes
Tidsram: 1 Day
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MDT will be used to elicit trade-offs that participants with ITP are willing to make between multiple treatment attributes.
Preference weights will be estimated for each treatment attribute included in the MDT.
Higher preference weights indicate treatment attributes that have a stronger influence on preferences, while lower weights indicate treatment attributes that have a weaker influence.
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1 Day
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Maximum Acceptable Risk (MAR) and Minimum Acceptable Benefit (MAB)
Tidsram: 1 Day
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To evaluate the benefit-risk trade-offs that participants are willing to make, marginal rates of substitutions (MRS) will be calculated based on the Dirichlet model. MRS will be represented as either MAR or MAB.
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1 Day
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Differences in Preference Weights Associated With Personal Characteristics
Tidsram: 1 Day
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Preference weights associated with personal characteristics will be assessed using covariate-adjusted Dirichlet regression.
Personal characteristics include sociodemographic, clinical characteristics such as race/ethnicity, living location, employment status, level of education, clinical setting usually treated in, ITP symptoms, and treatment experience, as well as other characteristics such as participants' risk tolerance level, health literacy and numeracy level.
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1 Day
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Cytopeni
- Patologiska processer
- Autoimmuna sjukdomar
- Immunsystemets sjukdomar
- Blödning
- Hudmanifestationer
- Hematologiska sjukdomar
- Blodkoagulationsstörningar
- Hemorragiska störningar
- Blodplättssjukdomar
- Trombotiska mikroangiopatier
- Purpura, trombocytopenisk
- Purpura
- Trombocytopeni
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Hemiska och lymfsjukdomar
- Purpura, Trombocytopenisk, Idiopatisk
Andra studie-ID-nummer
- CVAY736Q12001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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