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Long-term Follow-up of HLH Patients Who Received Treatment With NI-0501, an Anti-interferon Gamma Monoclonal Antibody

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ClinicalTrials.gov Identifier: NCT02069899
Recruitment Status : Recruiting
First Posted : February 24, 2014
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Supported by a grant of the 7th framework programme "FP7" from the European Committee
Information provided by (Responsible Party):
NovImmune SA

Tracking Information
First Submitted Date  ICMJE December 23, 2013
First Posted Date  ICMJE February 24, 2014
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE July 2014
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
Safety Endpoints [ Time Frame: Up to 12 months post transplant or post last dose of NI-0501 ]
The incidence, intensity, possible relationship to NI-0501 and outcomes of adverse events, serious and non-serious, will be assessed throughout the study. Vital signs, physical examination and laboratory values: evolution over time.
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2014)
Safety Endpoints [ Time Frame: Up to 12 months post transplant ]
The incidence, intensity, possible relationship to NI-0501 and outcomes of adverse events, serious and non-serious, will be assessed throughout the study. Vital signs, physical examination and laboratory values: evolution over time.
Change History Complete list of historical versions of study NCT02069899 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: March 22, 2018)
  • Efficacy endpoints [ Time Frame: Pre transplant, 30, 60, 100 days and 6, 12 months post transplant or post last dose of NI-0501 ]
    Survival
  • Pharmacokinetics [ Time Frame: Up to 6 months after last NI-0501 infusion ]
    - NI-0501 elimination profile
  • Pharmacodynamics [ Time Frame: Up to 6 months after last NI-0501 infusion ]
    • IFNγ total, as long as NI-0501 can be measured
    • IFNγ free, as soon as NI-0501 is not detectable
    • Exploratory parameters/disease markers
  • Immunogenicity [ Time Frame: Up to 6 months after last NI-0501 infusion ]
    Presence of anti-drug antibodies (i.e. ADAs)
Original Other Pre-specified Outcome Measures
 (submitted: February 20, 2014)
  • Efficacy endpoints [ Time Frame: Pre transplant, 30, 60, 100 days and 6, 12 months post transplant ]
    Clinical Response:
    • just before the start of conditioning and prior to Transplantation
    • at 30 days, 100 days, 6 months and 12 months after Transplantation
    Survival:
    • just before the start of conditioning and prior to Transplantation
    • at 100 days, 6 months and 12 months after Transplantation
  • Pharmacokinetics [ Time Frame: Up to 6 months after last NI-0501 infusion ]
    - NI-0501 elimination profile
  • Pharmacodynamics [ Time Frame: Up to 6 months after last NI-0501 infusion ]
    • IFNγ total, as long as NI-0501 can be measured
    • IFNγ free, as soon as NI-0501 is not detectable
    • Exploratory parameters/disease markers
  • Immunogenicity [ Time Frame: Up to 6 months after last NI-0501 infusion ]
    Presence of anti-drug antibodies (i.e. ADAs)
 
Descriptive Information
Brief Title  ICMJE Long-term Follow-up of HLH Patients Who Received Treatment With NI-0501, an Anti-interferon Gamma Monoclonal Antibody
Official Title  ICMJE A Multicenter Study for the Long-term Follow-up of HLH Patients Who Received Treatment With NI-0501, an Anti-interferon Gamma Monoclonal Antibody
Brief Summary International, multicenter, long-term, follow-up study that will enroll HLH patients who have received NI-0501 in a previous clinical trial, in the context of the clinical development program for NI-0501
Detailed Description

The aim of this study is to monitor the long-term safety profile of patients who have previously received at least one dose of NI-0501, including survival at several time points after the administration of NI-0501.

Moreover to study the elimination profile of NI-0501 and to assess the immunogenicity of NI-0501.

Furthermore in the event that patients, upon request of the treating physician, will be maintained on NI-0501 treatment beyond the foreseen 8 weeks, NI-0501 safety, tolerability, efficacy and PK profile will be closely monitored in these patients until treatment discontinuation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hemophagocytic Lymphohistiocytosis
Intervention  ICMJE Drug: NI-0501
In the event that NI-0501 treatment needs to be prolonged beyond Week 8 foreseen in the previous study, and upon request of the treating physician, patients will continue receiving NI-0501 in the context of this study.
Study Arms  ICMJE NI-0501 only in case is requested
NI-0501, in the event that, upon request of the treating physician, NI-0501 treatment needs to be prolonged beyond Week 8 foreseen in the previous protocol, patients will continue receiving NI-0501 in the context of this study.
Intervention: Drug: NI-0501
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2018)
55
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2014)
10
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Having received at least one dose of NI-0501.
  • 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.

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cristina de Min, MD +41 61 201 1322 cdemin@novimmune.com
Listed Location Countries  ICMJE France,   Germany,   Italy,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Austria,   Czech Republic,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT02069899
Other Study ID Numbers  ICMJE NI-0501-05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NovImmune SA
Study Sponsor  ICMJE NovImmune SA
Collaborators  ICMJE Supported by a grant of the 7th framework programme "FP7" from the European Committee
Investigators  ICMJE Not Provided
PRS Account NovImmune SA
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP