Stamford, CTNCT07421167Now EnrollingIRB Ready

Primary Immune Thrombocytopenia (ITP) Clinical Trial in Stamford, CT

Access cutting-edge primary immune thrombocytopenia (itp) treatment through this clinical trial at a research site in Stamford. Study-provided care at no cost to qualified participants.

Sponsored by Novartis Pharmaceuticals

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Expert Care in Stamford

Access primary immune thrombocytopenia (itp) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related primary immune thrombocytopenia (itp) treatment provided free

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Check if you qualify for this primary immune thrombocytopenia (itp) clinical trial in Stamford, CT

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Why Participate?

  • No-Cost Study Care

  • Local to Stamford

    Convenient for CT residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Stamford site if eligible
  4. 4Begin participation

About This Primary Immune Thrombocytopenia (ITP) Study in Stamford

The purpose of this study is to investigate the tolerability of ianalumab (9 mg/kg) with investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants diagnosed with primary immune thrombocytopenia (ITP) who have been treated with at least one but no more than four prior treatments, and with no change in IC TPO-RA dose in at least the last 14 days prior to the start of ianalumab.

Sponsor: Novartis Pharmaceuticals

Who Can Participate

Inclusion Criteria

Signed informed consent must be obtained prior to participation in the study.
Patients aged 18 years and older on the day of signing the informed consent.
ITP cohort only: Confirmed diagnosis of primary ITP that has previously responded to corticosteroid treatment or IVIG treatment but the response was not sustained (response is defined as a platelet count ≥ 50 G/L).
ITP cohort only: Received at least one prior treatment for ITP.
ITP cohort only: Patients with a platelet count \< 100 G/L who are receiving a TPO-RA. Patients may already be receiving a TPO-RA or may start a TPO-RA at the time of screening. All patients should be on a stable dose of TPO-RA for at least 14 days prior to first dose of ianalumab. Note: during the screening period, a documented assessment of platelets \< 100 G/L is mandatory for enrollment. For patients who received rescue medication before screening, platelet count results obtained prior to the start of the rescue therapy should be used to assess eligibility if collected within 14 days prior to screening.
ES cohort only: Patients with clinical diagnosis of primary ES with active thrombocytopenia (\< 100 G/L) with warm autoimmune hemolytic anemia (wAIHA) for whom a TPO-RA is appropriate per Investigator.
ES cohort only: Inadequate response to or relapse after treatment with corticosteroid therapy.
ES cohort only: Diagnosis confirmed by current or past positive direct antiglobulin test (DAT) (IgG+, with or without C3+) and evidence of hemolysis.
ES cohort only: any supportive care treatment administered for wAIHA must be stable for at least 4 weeks prior to enrollment. Key

Exclusion Criteria

Patients being treated with TPO-RA for \> 6 months.
Current life-threatening bleeding (related to thrombocytopenia).
Prior splenectomy within 6 months of first administration of ianalumab.
Patients with the following laboratory abnormalities:
Neutrophils: \< 1000/mm3
Serum creatinine \> 1.5 × upper limit of normal (ULN)
Aspartate aminotransferase (AST) \> 3.0 × ULN
Alanine aminotransferase (ALT) \> 3.0 × ULN
Immunoglobulin G (IgG) \< 5 g/L
ITP cohort only: hemoglobin \< 10 g/L, total bilirubin \> 1.5 × ULN
Patients with significantly compromised liver disease (Child-Pugh 7 to 9) and decompensated liver disease (Child-Pugh 10 to 15).
Treatment with a B-cell depleting therapy (e.g. rituximab or anti-B cell Activating Factor (e.g. belimumab) within 12 weeks prior to the first administration of ianalumab. Patients who are refractory to rituximab will be excluded from this trial, where refractory is defined as: \~ Patients who have not achieved a response (defined as platelet count ≥ 30 G/L and at least doubling from baseline within 12 weeks in the absence of rescue therapy) following completion of a standard course of rituximab
History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.
Known history of primary or secondary immunodeficiency, or a positive human immunodeficiency virus (HIV) enzyme-linked immunosorbent assay (ELISA) and Western blot) test result.
Patients exposed to more than 4 prior treatments for ITP.
ITP cohort only: Diagnosis of secondary thrombocytopenia.
ITP cohort: Use of immunosuppressant drugs other than corticosteroids or rituximab.
ES cohort only: Diagnosis of secondary ES.
ES cohort only: Life-threatening hemolysis.
ES cohort only: patients with autoimmune hemolytic anemia other than wAIHA

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Stamford?

Yes, this clinical trial (NCT07421167) has an active research site in Stamford, CT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Primary Immune Thrombocytopenia (ITP) Treatment Options in Stamford, CT

If you're searching for primary immune thrombocytopenia (itp) treatment options in Stamford, CT, this clinical trial (NCT07421167) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Stamford research site is actively enrolling participants for this clinical trial. You'll receive care from experienced primary immune thrombocytopenia (itp) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all primary immune thrombocytopenia (itp) clinical trials near you to find additional studies recruiting in your area.

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