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Trial details
Trial details
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies
Current status:
Approved
|
Date registered:
21/08/2023
Trial version(s)
History: 28/03/2023
History: 28/03/2023
History: 28/03/2023
History: 28/03/2023
History: 28/03/2023
Current: 28/03/2023
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2023045322
Protocol number
CKJX839C12001B
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Novartis Pharma AG
Primary sponsor: Country of origin
Novartis Pharma AG
Public title
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies
Acronym
Scientific title
An Open-label, Single Arm, Multicenter Extension Study to Evaluate Long-term Safety and Tolerability of Inclisiran in Participants With Heterozygous or Homozygous Familial Hypercholesterolemia Who Have Completed the Adolescent ORION-16 or ORION-13 Studies (VICTORION-PEDS-OLE)
Acronym
Brief summary of the study: English
The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 or ORION-13 studies
Brief summary of the study: Arabic
دراسة تمديد مفتوحة التسمية ومتعددة المراكز من مجموعة واحدة لتقييم سلامة إنكليسيران وقدرة تحمّله على المدى الطويل لدى مشاركين مصابين بفرط كوليسترول الدم العائلي متغاير الزيجوت أو متماثل الزيجوت أنجزوا دراسة أوريون- 16 (ORION-16) أو دراسة أوريون - 13(ORION-13) للمراهقين (VICTORION-PEDS-OLE)
Health conditions/problem studied: Specify
Heterozygous or Homozygous Familial Hypercholesterolemia
Interventions: Specify
Drug: Inclisiran Inclisiran sodium 300mg (equivalent to 284mg inclisiran*) in 1.5mL solution administered subcutaneously in pre-filled syringe Other Name: KJX839
Key inclusion and exclusion criteria: Inclusion criteria
Key inclusion: 1- Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16 or ORION-13 studies 2- Per investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16 or ORION-13 studies
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
12
Key inclusion and exclusion criteria: Age maximum
17
Key inclusion and exclusion criteria: Exclusion criteria
Key exclusion: 1- Participants who in the feeder inclisiran ORION-16 and ORION-13 studies either screen failed or permanently discontinued from the treatment/study for any reason or had serious safety or tolerability issues related to inclisiran treatment 2- Any uncontrolled or serious disease, or any medical, physical, or surgical condition, that may either interfere with participation in the clinical study or interpretation of clinical study results, and/or put the participant at significant risk
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Single Arm Study
Study design: Masking
Open (masking not used)
Study design: Control
N/A
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Single
IMP has market authorization
Yes, Worldwide
IMP has market authorization: Specify the countries
European Union, United Arab Emirates, Great Britain
Name of IMP
Inclisiran
Type of IMP
Others
Type of IMP: Specify
siRNA
Pharmaceutical class
Cholesterol-lowering small interfering ribonucleic acid (siRNA) that inhibits the production of proprotein convertase subtilisin/kexin type 9 (PCSK9)
Therapeutic indication
Heterozygous or Homozygous Familial Hypercholesterolemia
Therapeutic benefit
Treatment
Biospecimen retention
Samples without DNA
Biospecimen description
Blood samples collected will be analyzed at Medpace Laboratories, central Lab
Target sample size
4
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
30/08/2023
Date of study closure: Type
Anticipated
Date of study closure: Date
30/08/2026
Recruitment status
Pending
Date of completion
IPD sharing statement plan
Yes
IPD sharing statement description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT05682378
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
clinical trials.gov
NCT05682378
Sources of Monetary or Material Support
Name
Novartis Pharma AG
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Selim
Jambart
Beirut
Lebanon
009613406001
sjambart@dm.net.lb
Hotel Dieu De France
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
009611512002 Ext. 271 E
hind.khairallah@fattal.com.lb
khalil Fattal et Fils s.a.l
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu De France
Selim Jambart
Endocrinology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
30/03/2023
Sami Richa
cue@usj.edu.lb
00961421229
Countries of Recruitment
Name
Lebanon
Brazil
Canada
France
Germany
Greece
Hungary
Italy
Netherlands
Norway
Poland
Russian Federation
Slovenia
Spain
Switzerland
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
Heterozygous or homozygous familial hypercholesterolemia
Hyperlipidaemia, unspecified (E78.5)
Heterozygous or homozygous familial hypercholesterolemia
Interventions
Intervention
Description
Keyword
Consenting, IMP administration, Laboratory testing, Imaging
Consenting, IMP administration, Laboratory testing, Imaging
Consenting, IMP administration, Laboratory testing, Imaging
Primary Outcomes
Name
Time points
Measure
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Time Frame: From Day 1 in the study up to the end of study visit; up to 1080 days
Safety and tolerability: TEAEs, TESAEs (incidence, severity, relationship to study drug and discontinuation due to TEAEs)
Key Secondary Outcomes
Name
Time points
Measure
Percentage and absolute change in LDL-C from baseline in the feeder study to end of study
Time Frame: Baseline (of feeder study) and Day 1080
Evaluate the long-term effect of inclisiran (from baseline of feeder study to end of study) in lowering LDL-C
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Initial Submission - HDF
20/04/2023
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