Recruiting

Observational Study

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07786077

Conditions

Primary Immune Thrombocytopenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Primary Immune Thrombocytopenia

Study ID

NCT07786077

Start date

Dec 8, 2025

Status verified date

Aug, 2026

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

1. Currently living in the US.
2. Aged 18 years and older on the day of providing informed consent.
3. 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:

1. For participants receiving 1L treatment for ITP only: Previous or current use of treatments different from corticosteroids and/or IVIg/anti-D immunoglobulin.
2. 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).

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

ITP Cohort

Adults with ITP in the US who are being treated in either 1L or 2L settings.

Primary outcome measure

  • Preference Weights for Treatment Attributes [ Time Frame: 1 Day ]
  • Maximum Acceptable Risk (MAR) and Minimum Acceptable Benefit (MAB) [ Time Frame: 1 Day ]
  • Differences in Preference Weights Associated With Personal Characteristics [ Time Frame: 1 Day ]

Central Contacts and Locations

Central contacts

Locations

Novartis

Recruiting

East Hanover, New Jersey, United States, 07936

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Primary Immune Thrombocytopenia
  • ITP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-25.