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

Overview

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.

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: December 29, 2023

Interventions

• 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)

Arms, Groups and Cohorts

• Experimental: sacubitril/valsartan
  • single arm, open label sacubitril/valsartan

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Novartis Pharmaceuticals
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals