CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: sacubitril/valsartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue Exclusion Criteria: Subject only participated in PANORAMA-HF Part 1 or was a SF 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sacubitril/valsartan<br>single arm, open label sacubitril/valsartan | Drug: sacubitril/valsartan<br>* 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)<br>* Other names: LCZ696;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events (AEs) as a measure of safety and tolerability | Safety. Assessments include: Adverse Events (AEs) | to end of study, up to 3 years | 
| Number of participants with Serious Adverse Events (SAEs) as a measure of safety and tolerability | Safety. Assessments include: Serious Adverse Events (SAEs) | to end of study, up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, pediatric, LCZ696, sacubitril/valsartan, open-label study, angiotensin receptor neprilysin inhibitor