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

Heart Failure Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03785405
• Other study ID #: CLCZ696B2319E1
• Status: Completed
• Phase: Phase 3
• Start date: May 2, 2019
• Est. completion date: December 29, 2023

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 29, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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)

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Ciudad de Salta	Provincia De Salta
Austria	Novartis Investigative Site	Innsbruck
Bulgaria	Novartis Investigative Site	Sofia
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Toronto	Ontario
Croatia	Novartis Investigative Site	Zagreb
Czechia	Novartis Investigative Site	Praha 5
Finland	Novartis Investigative Site	Helsinki
France	Novartis Investigative Site	Paris 15
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Stuttgart
Hungary	Novartis Investigative Site	Budapest
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Kochi	Kerala
India	Novartis Investigative Site	New Delhi
India	Novartis Investigative Site	New Delhi	Delhi
Israel	Novartis Investigative Site	Be'er-Sheva
Italy	Novartis Investigative Site	Bergamo	BG
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Torino	TO
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Japan	Novartis Investigative Site	Obu	Aichi
Japan	Novartis Investigative Site	Omura	Nagasaki
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Sapporo city	Hokkaido
Japan	Novartis Investigative Site	Setagaya-ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku ku	Tokyo
Japan	Novartis Investigative Site	Toyama-city	Toyama
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Yangsan Si	Gyeongsangnam Do
Lebanon	Novartis Investigative Site	Ashrafieh
Lebanon	Novartis Investigative Site	Beirut
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Wroclaw
Portugal	Novartis Investigative Site	Carnaxide	Lisboa
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Lisboa
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Saint Petersburg
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
South Africa	Novartis Investigative Site	Soweto	Gauteng
Spain	Novartis Investigative Site	Barcelona	Cataluna
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Switzerland	Novartis Investigative Site	Lausanne
Taiwan	Novartis Investigative Site	Tainan
Taiwan	Novartis Investigative Site	Taipei
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkoknoi	Bangkok
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Konak-Izmir
United States	CS Mott Children's Hospital CLCZ696B2319	Ann Arbor	Michigan
United States	Childrens Healthcare Of Atlanta	Atlanta	Georgia
United States	Childrens Hospital Boston CAFQ056B2252	Boston	Massachusetts
United States	Sanger Heart and Vascular Institute	Charlotte	North Carolina
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	Novartis Investigative Site	Loma Linda	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	University of Minnesota Cardiovascular Clinical Trials Ctr CLCZ696B2319	Minneapolis	Minnesota
United States	Col Uni Med Center New York Presby CDEB025A2306	New York	New York
United States	Novartis Investigative Site	Palo Alto	California
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	All Childrens Hospital	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Bulgaria,  Canada,  Croatia,  Czechia,  Finland,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Lebanon,  Poland,  Portugal,  Russian Federation,  Singapore,  South Africa,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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