A Study of Patients' Preferences for Primary Immune Thrombocytopenia Treatment
ConditionPrimary Immune Thrombocytopenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals
About this trial
This study aims to evaluate treatment preferences of patients with Primary Immune Thrombocytopenia (ITP) in the United States (US) by conducting a preference elicitation survey.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Currently living in the US.
Aged 18 years and older on the day of providing informed consent.
Disqualifiers
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).
Trial population
Adults receiving 1L or 2L treatment for ITP who reside in the US.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: ITP Cohort
Trial outcomes
Primary outcomes
1
Preference Weights for Treatment Attributes
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.
Time frame
1 Day2
Maximum Acceptable Risk (MAR) and Minimum Acceptable Benefit (MAB)
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. * MAR measures the median maximum level of risk that participants are willing to tolerate in certain treatment attributes in return for a specified improvement in other treatment attributes. * MAB measures the median minimum level of benefit required in certain treatment attributes for participants to tolerate deteriorations in other treatment attributes.
Time frame
1 Day3
Differences in Preference Weights Associated With Personal Characteristics
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.
Time frame
1 DaySponsors and contacts
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Source ClinicalTrials.gov