Toggle navigation
Lebanon Clinical Trials Registry
Home
About Us
FAQs
Contact Us
Search Trials
Register
Log in
User Guide
Trial details
You are here
Home
Search Trials
Trial details
Trial details
CLCZ696B2319E1 Open Label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With Heart Failure (HF).
Current status:
Approved
|
Date registered:
02/11/2023
Trial version(s)
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
History: 17/07/2019
Current: 17/07/2019
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2019070266
Protocol number
CLCZ696B2319E1
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 Services
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
CLCZ696B2319E1 Open Label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With Heart Failure (HF).
Acronym
Scientific title
A multicenter study to evaluate long-term safety and tolerability of open label sacubitril/valsartan in pediatric patients with heart failure due to systemic left ventricle systolic dysfunction who have completed study CLCZ696B2319
Acronym
Brief summary of the study: English
The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan
Brief summary of the study: Arabic
دراسة متعددة المراكز لتقييم السلامة الطويلة الأمد لدواء ساكيوبيتريل / فالسارتان المفتوح اللصاقة وقدرة تحمّله لدى أطفال مرضى مصابين بفشل القلب بسبب الخلل الوظيفي الانقباضي الجهازي للبُطيْن الأيسر وقد أنجزوا دراسة CLCZ696B2319
Health conditions/problem studied: Specify
Heart failure patients
Interventions: Specify
Drug: sacubitril/valsartan Target dose 3.1 mg/kg bid Formulations: Tablets (50, 100, 200 mg) Granules [12.5 mg (4 granules), 31.25 mg (10 granules), in capsules] Liquid (1 mg/ml, 4 mg/ml, prepared from tablets) Other Name: LCZ696
Key inclusion and exclusion criteria: Inclusion criteria
Signed informed consent On study drug at PANORAMA-HF Part 2 End of Study visit. Does not have any significant safety issue
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
1
Key inclusion and exclusion criteria: Age maximum
18
Key inclusion and exclusion criteria: Exclusion criteria
Subject only participated in PANORAMA-HF Part 1 or was a Screen Failure in PANORAMA-HF or permanently discontinued study drug in PANORMA-HF Part 2 Use of investigational drugs within 5 half-lives of enrollment or within 30 days (longer duration); with the exception of PANORAMA-HF study drug (requires >/=36-hour washout before baseline visit) History of hypersensitivity or allergy to study treatment, its excipients or drugs of similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspected contraindications to sacubitril/valsartan Renal vascular hypertension (including renal artery stenosis) Significant renal estimated glomerular filtration rate disorder (eGFR calculated using modified Schwartz formula <30% mean GFR for age); hepatic disorder (serum aspartate aminotransferase or alanine aminotransferase > 3 times upper limit of normal); gastrointestinal disorder or biliary disorder History of angioedema Parents or legal guardians of subject who do not give consent or allow the child to give assent, or inability of patient or parents/legal guardians to follow instructions or comply with follow-up procedures Any medical condition(s) that may put the patient at risk in the investigator's opinion or that the investigator deems unsuitable for the study Other protocol defined inclusion/exclusion criteria may apply
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Safety
Trial scope: Specify scope
Study design: Allocation
N/A: Single arm study
Study design: Masking
Open (masking not used)
Study design: Control
N/A
Study phase
2
Study design: Purpose
Treatment
Study design: Assignment
Single
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
Lebanon and worldwide : yes for the dosage forms 50,100 and 200 mg and No for 12.5 and 31.25 mg
Name of IMP
sacubitril/valsartan
Year of authorization
2015
Month of authorization
11
Type of IMP
Others
Type of IMP: Specify
Angiotensin receptor neprilysin inhibitor (ARNI)
Pharmaceutical class
LCZ696, also known as Entresto® (sacubitril/valsartan) is an angiotensin receptor neprilysin inhibitor (ARNI), providing concomitant neprilysin (neutral endopeptidase 24.11, NEP) inhibition and angiotensin II type 1 (AT1) receptor blockade
Therapeutic indication
Pediatric patients with heart failure
Therapeutic benefit
long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.
Biospecimen retention
Samples without DNA
Biospecimen description
blood and urine samples
Target sample size
6
Actual enrollment target size
9
Date of first enrollment: Type
Actual
Date of first enrollment: Date
03/01/2020
Date of study closure: Type
Actual
Date of study closure: Date
30/12/2023
Recruitment status
Complete
Date of completion
13/12/2021
IPD sharing statement plan
No
IPD sharing statement description
Undecided
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT03785405?cond=pediatric+heart+failure&rank=8&view=record
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinicaltrials.gov
NCT03785405
Sources of Monetary or Material Support
Name
Novartis Pharma Services
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Linda
Daou
Beirut
Lebanon
961604976
drlindadaou@gmail.com
Hotel Dieu
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Nasser
Audi
Beirut
Lebanon
+961 76 708060
dr.nasser.audi@gmail.com
Rafic Hariri University Hospital
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu de France
Linda Daou
Pediatric Cardiology
Approved
Rafik Hariri University Hospital
Nasser Audi
Pediatri Cardiology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
06/06/2019
Sami Richa
cue@usj.edu.lb
961421229
Rafic Hariri University Hospital
28/01/2019
Rawan Yamout
rawan.yamout@crurhuh.com
018300000 ext 2037
Countries of Recruitment
Name
Austria
Argentina
Canada
Croatia
Czech Republic
Egypt
Finland
France
Germany
Hungary
India
Japan
Jordan
Poland
Portugal
Romania
Russian Federation
Saudi Arabia
Singapore
South Africa
Democratic People Republic of Korea
Spain
Sweden
Switzerland
Thailand
Turkey
United Kingdom
United States of America
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Heart Failure
Heart failure (I50)
HF
Interventions
Intervention
Description
Keyword
ICF, Physical Exam, ECG, Lab tests
ICF, Physical Exam, ECG, Lab tests
ICF, Physical Exam, ECG, Lab tests
Primary Outcomes
Name
Time points
Measure
Number of participants with Adverse Events (AEs) as a measure of safety and tolerability
to end of study, up to 3 years
safety and tolerability
.Number of participants with Serious Adverse Events (SAEs) as a measure of safety and tolerability
to end of study, up to 3 years
safety and tolerability
Key Secondary Outcomes
Name
Time points
Measure
No secondary objectives
NA
NA
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
Annual Review 2023
24/10/2023
LCZ696 IB Edition 24
24/10/2023
LCZ696 SUSARs 01Apr2023-30Sep2023
24/10/2023
Download as PDF
Save a PDF copy of the summary of the trial