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A multicentre study for the long-term follow-up of HLH patients who received treatment with NI-0501, an anti-interferon gamma monoclonal antibody

A multicentre study for the long-term follow-up of HLH patients who received treatment with NI-0501, an anti-interferon gamma monoclonal antibody - NI-0501-05

Status
Unknown
Phases
Phase 2
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48933
Enrollment
3
Registered
2018-10-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Juvenile Idiopathic Arthritis Systemic juvenile rheumatoid Arthritis

Interventions

None listed

Sponsors

Swedish Orphan Biovitrum AG
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Having received at least one dose of NI-0501 during a previous NI-0501 study or under a compassionate use (CU) treatment protocol. 2. Informed Consent signed by the patient or the patient*s legal representative(s), as applicable, with the assent of patients who are legally capable of providing it.

Exclusion criteria

Exclusion criteria: Please see inclusion criteria.

Design outcomes

Primary

MeasureTime frame
Study Parameters: * Vital signs, including body temperature * Physical examination, including liver and spleen sizes * Laboratory parameters: complete blood count, coagulation tests (aPTT, PT, d-Dimers and fibrinogen), ferritin,CRP, LDH, glucose, triglycerides, , liver(alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, total bilirubin and alkaline phosphatases) and renal function tests (creatinine, albumin, urea) * Pharmacokinetics: circulating NI-0501 concentration * Pharmacodynamics: circulating IFNγ levels, CXCL9, CXCL10 and exploratory markers of disease activity (e.g. sCD25) * Anti-drug antibodies (ADAs).—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)