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RecruitingLast updated: 3 November 2023

VAYHIT2: This study is evaluating the effectiveness of two different doses of targeted therapy added to a drug called eltrombopag in people with Primary Immune Thrombocytopenia (ITP) who have had an insufficient response or relapsed after first line steroid treatmentA Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment

Clinical summary

Summary

This study is comparing the effectiveness of two different doses of targeted therapy (called ianalumab) comapred to placebo, when added to eltrombopag. Eligible participants will be randomly allocated to one of three treatment arms.

In Arm 1 (Experimental), participants will receive eltrombopag and lower dose ianalumab. 

In Arm 2 (Experimental), participants will receive eltrombopag and higher dose ianalumab.

in Arm 2 (Placebo Comparator), participants will receive eltrombopag and placebo.

Eltrombopag will be administered as a film-coated tablet for oral use. Ianalumab and Placebo will be given as an intravenous (IV) infusion.

Conditions

This trial is treating patients with Primary Immune Thrombocytopenia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

VAYHIT2

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • CVAY736Q12301

Trial sponsor

Novartis Pharmaceuticals

Scientific Title

A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment

Eligibility

Inclusion

  1. Male or female patients aged 18 years and older on the day of signing the informed consent.
  2. A signed informed consent must be obtained prior to participation in the study.
  3. A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG.
  4. Platelet count <30 G/L and assessed need for treatment (per physician's discretion).

Exclusion

  1. ITP patients who received second-line ITP treatments (other than steroid therapy± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (max one week) before screening are eligible.
  2. Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia
  3. Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters
  4. Patients with current or history of life-threatening bleeding
  5. Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAB)-positive
  6. Patients with known active or uncontrolled infection requiring systemic treatment during screening period
  7. Patients with hepatic impairment
  8. Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication
  9. Female patients who are pregnant or nursing

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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