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NCT Number: NCT07786077

A Study of Patients' Preferences for Primary Immune Thrombocytopenia Treatment

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.

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Key information

Conditions

Primary Immune Thrombocytopenia Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Preference Weights for Treatment Attributes

    Time frame: 1 Day

    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.

  2. Maximum Acceptable Risk (MAR) and Minimum Acceptable Benefit (MAB)

    Time frame: 1 Day

    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.

  3. Differences in Preference Weights Associated With Personal Characteristics

    Time frame: 1 Day

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Patients' Preferences for Primary Immune Thrombocytopenia Treatment

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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