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 (VAYHIT2)

Phase 3

• Conditions: low platelet count; Primary immune thrombocytopenia; 10035534

• Registration Number: NL-OMON56456
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

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. 4. Patients
with Platelet count below 30 G/L for whom eltrombopag is clinically indicated
as per physician*s discretion and with no contraindication to receive
eltrombopag.

Exclusion Criteria

1. ITP patients who received second-line ITP treatments (other than
corticosteroid 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 (patients with low grade anemia related to bleeding or iron
deficiency are eligible).
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), HBsAg positive are excluded. Participants who are hepatitis core
antibody (HBcAb) positive are also executed unless all of the following
criteria are met: HbsAg and HBV DNA are negative, participant has no pre
existing liver fibrosis, hepatitis B monitoring is implemented , including
regular ALT testing and HBV DNA testing. Antiviral prophylaxis with entecavir
must be initiated prior randomization and must continue during the treatment
period and at least 12 months after the last dose of ianalumab /placebo. If
antiviral prophylaxis with entecavir is not allowed as per local guidelines or
local clinical practice, clinically contraindicated or not accepted by the
patient, participants who are HBsAg negative and HBcAb positive are not
eligible.
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
anti-platelet or anticoagulant medication with an exemption of low dose of
acetylsalicylic acid (<=150 mg daily).
9. Female patients who are pregnant or nursing

Study & Design

• Study Type: Interventional
• Study Design: Not specified