A study to investigate the long-term safety and efficacy of a new drug, NI-0501, in children with a disease that is called Haemophagocytic Lymphohistiocytosis.
- Conditions
- Haemophagocytic lymphohistiocytosisMedDRA version: 21.1 Level: PT Classification code 10071583 Term: Haemophagocytic lymphohistiocytosis System Organ Class: 10021428 - Immune system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-005753-23-GB
- Lead Sponsor
- Swedish Orphan Biovitrum AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 55
1. Having received at least one dose of NI-0501 during a previous NI-0501 study or under a CU treatment protocol
2. 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
3. Having agreed to continue using adequate methods of birth control until 6 months after the last administered dose of NI-0501, whenever relevant. Males with partners(s) of child-bearing potential must agree to take appropriate precautions to avoid fathering a child until 6 months after receiving last dose of NI-0501.
Are the trial subjects under 18? yes
Number of subjects for this age range: 55
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
None
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method