A study to investigate the long-term safety and efficacy of a new drug, NI-0501, in children with a disease that is called reactivated Primary Haemophagocytic Lymphohistiocytosis.

• Conditions: Primary haemophagocytic lymphohistiocytosis which has reactivated.; MedDRA version: 16.1Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-005753-23-CZ
• Lead Sponsor: ovImmune SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-30
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Having received at least one dose of NI-0501 during a previous NI-0501 study.
2. Having signed the Informed Consent by the patient or the patient's legal representative(s), as applicable, with the assent of patients who are legally capable of providing it.
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

None.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified