Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)

Heart Failure With Reduced Ejection Fraction (HF-rEF) Clinical Trial

Official title:

Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02389933
• Other study ID #: CLCZ696B2318M
• Status: No longer available

Study information

• Verified date: February 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide access to life-saving treatment with LCZ696 for patients that were not previously exposed to LCZ696 but have no other option to receive LCZ696 in their country prior to market authorization OR commercial availability, based on local regulatory and legal requirements.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

The patient(s) for whom the MPP is sought meets all of the following:

• Is suffering from a serious or life-threatening disease or condition

• Does not have access to a comparable or satisfactory alternative treatment (i.e., comparable or satisfactory treatment is not available or does not exist)

• Patient should be on optimized standard of care treatment, including treatment with ARBs or ACEI, beta-blockers and MRA;

• Intolerance to evidence-based target doses should be documented by the treating physician

• Meets any other relevant medical criteria for compassionate use of the investigational product

Patients eligible for inclusion in this program have to fulfill all of the following criteria:

1. Adult patients (but not younger than 18 year old) will be included, upon completion of written informed consent before any assessment is performed.

2. Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction:

• LVEF = 35% at the time of screening for participation in the program (any local measurement, made within the past 6 months using echocardiography, MUGA, CT scanning, MRI or ventricular angiography is acceptable, provided there are no subsequent measurement above 35%)

3. Patient had a hospitalization for HF within the last 12 months

4. Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior to starting treatment with LCZ696

5. Patients must be treated with a ß-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to starting treatment with LCZ696 (reason should be documented for patients not on CHF target doses per local guidelines, or in absence of that medication).

6. An aldosterone antagonist should also be considered in all patients, taking account of renal function, serum potassium and tolerability. If given, the dose of aldosterone antagonist should be optimized according to guideline recommendations and patient tolerability, and should be stable for at least 4 weeks prior to starting treatment with LCZ696

Exclusion criteria

Patients fulfilling any of the following criteria are not eligible for inclusion in this program:

1. The patient is eligible for participation in any of the IMP's ongoing clinical trials

2. The patient has recently completed a clinical trial that has been terminated and other options (e.g., trial extensions, amendments, etc.) are available to continue a similar treatment.

3. The patient is being transferred from an ongoing clinical trial for which the patient is still eligible for participation

4. History of hypersensitivity or allergy to LCZ696 or to any of its metabolites; to drugs of similar chemical classes, ARBs, or NEP inhibitors; as well as known or suspected contraindications to LCZ696

5. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer

6. Previous history of intolerance to recommended target doses of ARBs

7. Known history of angioedema

8. Requirement of concomitant treatment with both ACEIs and ARBs

9. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)

10. Symptomatic hypotension and/or a SBP less than 100 mm Hg over the last 4 weeks prior to starting treatment with LCZ696

11. Estimated GFR below 30 mL/min/1.73m2 as measured by the simplified MDRD formula

12. Presence of bilateral renal artery stenosis

13. Serum potassium above 5.2 mmol/L during the week prior to starting treatment with LCZ696

14. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to starting treatment with LCZ696

15. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after the schedule date to start treatment with LCZ696

16. Implantation of a cardiac resynchronization therapy pacemaker (CRT-P) or a cardiac resynchronization therapy defibrillator (CRT-D) or upgrading of an existing conventional pacemaker or an implantable cardioverter defibrillator (ICD) to CRT device within 3 months prior to starting treatment with LCZ696, or intent to implant such a device.

Also, patients who had implantation of a conventional pacemaker or an ICD or had a revision of a pacemaker or other device leads within 1 month before starting treatment with LCZ696 are excluded.

17. Heart transplant or ventricular assistance device (VAD) or intent to transplant (on transplant list) or implant a VAD

18. History of severe pulmonary disease

19. Diagnosis of peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to starting treatment with LCZ696

20. Documented untreated ventricular arrhythmia with syncopal episodes within the 3 months prior to starting treatment with LCZ696

21. Symptomatic bradycardia or second or third degree heart block without a pacemaker

22. Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation

23. Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis

24. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs, including but not limited to any of the following:

• History of active inflammatory bowel disease during the 12 months before starting treatment with LCZ696.

• Current duodenal or gastric ulcers during the 3 months prior to starting treatment with LCZ696

• Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2 x ULN prior to starting treatment with LCZ696, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt

• Active treatment with cholestyramine or colestipol resins

25. Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN prior to starting treatment with LCZ696, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt

26. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (above 5 mIU/mL)

27. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method (if accepted by the local regulatory authority and ethics committee) or a barrier method plus a hormonal method

• Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progesterone agent.

• Reliable contraception should be maintained throughout the treatment and for 7 days after LCZ696 treatment discontinuation

• Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea, or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.

28. Presence of any other disease with a life expectancy of < 3 years

29. Any condition, not identified in the protocol that in the opinion of the treating physician is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the therapy.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction (HF-rEF)

Intervention

Drug:
• LCZ696
immediate release film coated tablet in 50 mg, 100 mg, 200 mg, and 400 mg strengths for oral administration.

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Darlinghurst	New South Wales
Australia	Novartis Investigative Site	North Ryde	New South Wales
Australia	Novartis Investigative Site	Perth	Western Australia
Austria	Novartis Investigative Site	Krems
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	St. Poelten
Austria	Novartis Investigative Site	Vienna
Austria	Novartis Investigative Site	Wien
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investigative Site	Fortaleza	CE
Brazil	Novartis Investigative Site	Porto Alegre	Rio Grande Do Sul
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Salvador	BA
Croatia	Novartis Investigative Site	Varazdin	HRV
Cyprus	Novartis Investigative Site	Limassol
Cyprus	Novartis Investigative Site	Nicosia
Cyprus	Novartis Investigative Site	Nicosia
Cyprus	Novartis Investigative Site	Nicosia
Cyprus	Novartis Investigative Site	Nicosia
Cyprus	Novartis Investigative Site	Nicosia
France	Novartis Investigative Site	Amiens cedex 1
France	Novartis Investigative Site	Amilly
France	Novartis Investigative Site	Angers Cedex 9
France	Novartis Investigative Site	Antibes
France	Novartis Investigative Site	Aressy
France	Novartis Investigative Site	Avignon
France	Novartis Investigative Site	Avignon Cedex 2
France	Novartis Investigative Site	Bayeux
France	Novartis Investigative Site	Beziers Cedex
France	Novartis Investigative Site	Bobigny
France	Novartis Investigative Site	Brest
France	Novartis Investigative Site	Brest Armees
France	Novartis Investigative Site	Bron
France	Novartis Investigative Site	Bron	Cedex
France	Novartis Investigative Site	Bron Cedex
France	Novartis Investigative Site	Caen	Cedex
France	Novartis Investigative Site	Caen
France	Novartis Investigative Site	Caen Cedex
France	Novartis Investigative Site	Cambrai Cedex
France	Novartis Investigative Site	Cannes Cedex
France	Novartis Investigative Site	Chambéry cedex
France	Novartis Investigative Site	Chaumont Cedex
France	Novartis Investigative Site	Cherbourg Octeville
France	Novartis Investigative Site	Clamart
France	Novartis Investigative Site	Clermont-Ferrand cedex 1
France	Novartis Investigative Site	Compiègne cedex
France	Novartis Investigative Site	Contamine Sur Arve
France	Novartis Investigative Site	Corbeil Essonnes
France	Novartis Investigative Site	Cornebarrieu
France	Novartis Investigative Site	Dijon
France	Novartis Investigative Site	Eaubonne
France	Novartis Investigative Site	Honfleur Cedex
France	Novartis Investigative Site	Hyeres
France	Novartis Investigative Site	La Roche sur Yon Cedex
France	Novartis Investigative Site	La Seyne sur mer
France	Novartis Investigative Site	La Tronche
France	Novartis Investigative Site	Lille Cedex
France	Novartis Investigative Site	Lille Cedex
France	Novartis Investigative Site	Limoges
France	Novartis Investigative Site	Lyon
France	Novartis Investigative Site	Lyon
France	Novartis Investigative Site	Lyon CEDEX 04
France	Novartis Investigative Site	Mâcon Cedex
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Marseille Cedex 05
France	Novartis Investigative Site	Marseille Cedex 20
France	Novartis Investigative Site	Marseille cedex 20	Bouches Du Rhone
France	Novartis Investigative Site	Metz Cedex
France	Novartis Investigative Site	Metz-Tessy
France	Novartis Investigative Site	Monaco
France	Novartis Investigative Site	Montbeliard Cedex
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Montpellier Cedex
France	Novartis Investigative Site	Morlaix Cedex
France	Novartis Investigative Site	Moulins Cedex
France	Novartis Investigative Site	Mulhouse Cedex
France	Novartis Investigative Site	Nantes Cedex 1
France	Novartis Investigative Site	Neuilly-sur-seine
France	Novartis Investigative Site	Nice Cedex 1
France	Novartis Investigative Site	Nice Cedex 2
France	Novartis Investigative Site	Nimes
France	Novartis Investigative Site	Paris Cedex 10
France	Novartis Investigative Site	Paris Cedex 13
France	Novartis Investigative Site	Paris Cedex 14
France	Novartis Investigative Site	Pau Cedex
France	Novartis Investigative Site	Perpignan
France	Novartis Investigative Site	Pessac Cedex
France	Novartis Investigative Site	Poitiers
France	Novartis Investigative Site	Pont L'Abbe
France	Novartis Investigative Site	Pontarlier Cedex
France	Novartis Investigative Site	Pontoise
France	Novartis Investigative Site	Rennes Cedex 9
France	Novartis Investigative Site	Rouen Cedex
France	Novartis Investigative Site	Rumilly
France	Novartis Investigative Site	Saint Denis
France	Novartis Investigative Site	Saint Denis
France	Novartis Investigative Site	Saint Denis	France / La Reunion
France	Novartis Investigative Site	Saint Etienne Cedex 2
France	Novartis Investigative Site	Saint Palais
France	Novartis Investigative Site	Saint-Germain-en-Laye
France	Novartis Investigative Site	St Jean
France	Novartis Investigative Site	St. Etienne
France	Novartis Investigative Site	Strasbourg
France	Novartis Investigative Site	Thonon Les Bains Cedex
France	Novartis Investigative Site	Toulouse
France	Novartis Investigative Site	Toulouse Cedex
France	Novartis Investigative Site	Tours
France	Novartis Investigative Site	Valence Cedex 9
France	Novartis Investigative Site	Valenciennes Cedex
France	Novartis Investigative Site	Vandoeuvre Les Nancy
France	Novartis Investigative Site	Vichy
France	Novartis Investigative Site	Villefranche sur Saone
France	Novartis Investigative Site	Wattrelos
Germany	Novartis Investigative Site	Ahlen
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Bad Endbach
Germany	Novartis Investigative Site	Bad Homburg
Germany	Novartis Investigative Site	Bad Kreuznach
Germany	Novartis Investigative Site	Bad Krozingen
Germany	Novartis Investigative Site	Bad Oeynhausen
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Cologne
Germany	Novartis Investigative Site	Dessau-Rosslau
Germany	Novartis Investigative Site	Diepholz
Germany	Novartis Investigative Site	Dinslaken
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dusseldorf
Germany	Novartis Investigative Site	Eilenburg
Germany	Novartis Investigative Site	Eschwege
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Friedrichroda
Germany	Novartis Investigative Site	Goettingen
Germany	Novartis Investigative Site	Gronau
Germany	Novartis Investigative Site	Guenzburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hassfurt
Germany	Novartis Investigative Site	Hassloch
Germany	Novartis Investigative Site	Hohenstein-Ernstthal
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Karlsruhe
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Köthen
Germany	Novartis Investigative Site	Lauchringen
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Marl
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Munchen
Germany	Novartis Investigative Site	Munster
Germany	Novartis Investigative Site	Oldenburg
Germany	Novartis Investigative Site	Pressath
Germany	Novartis Investigative Site	Rostock
Germany	Novartis Investigative Site	Suderholz	OT Bartmannshagen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Weinheim
Germany	Novartis Investigative Site	Wildeshausen
Germany	Novartis Investigative Site	Wolfratshausen
Germany	Novartis Investigative Site	Wuerzburg
Greece	Novartis Investigative Site	Alexandroupolis	Evros
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Chaidari
Greece	Novartis Investigative Site	Chios
Greece	Novartis Investigative Site	Edessa
Greece	Novartis Investigative Site	Elefsina
Greece	Novartis Investigative Site	Glyfada
Greece	Novartis Investigative Site	Heraklion
Greece	Novartis Investigative Site	Heraklion - Crete
Greece	Novartis Investigative Site	Ioannina
Greece	Novartis Investigative Site	Ioannina	GR
Greece	Novartis Investigative Site	Kalamata
Greece	Novartis Investigative Site	Karditsa
Greece	Novartis Investigative Site	Katerini
Greece	Novartis Investigative Site	Kavala
Greece	Novartis Investigative Site	Kerkyra
Greece	Novartis Investigative Site	Kilkis
Greece	Novartis Investigative Site	Kozani
Greece	Novartis Investigative Site	Larissa	GR
Greece	Novartis Investigative Site	Maroussi
Greece	Novartis Investigative Site	Piraeus
Greece	Novartis Investigative Site	Piraeus
Greece	Novartis Investigative Site	Rio Patra
Greece	Novartis Investigative Site	Thesaloniki
Greece	Novartis Investigative Site	Thessaloniki
Greece	Novartis Investigative Site	Thessaloniki
Greece	Novartis Investigative Site	Thessaloniki
Greece	Novartis Investigative Site	Thessaloniki	GR
Greece	Novartis Investigative Site	Thessaloniki	GR
Greece	Novartis Investigative Site	Thessaloniki	GR
Greece	Novartis Investigative Site	Tripoli	GR
Greece	Novartis Investigative Site	Volos
Greece	Novartis Investigative Site	Voula	GR
Ireland	Novartis Investigative Site	Co Dublin
Ireland	Novartis Investigative Site	Dublin
Lebanon	Novartis Investigative Site	Ashrafieh
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Saida
Lebanon	Novartis Investigative Site	Tripoli
Malta	Novartis Investigative Site	Msida
Panama	Novartis Investigative Site	Panama
Panama	Novartis Investigative Site	Panama City
Philippines	Novartis Investigative Site	Makati City
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site	Manila	Metro Manila
Slovenia	Novartis Investigative Site	Ljubljana
Spain	Novartis Investigative Site	Badajoz	Extremadura
Spain	Novartis Investigative Site	Badalona
Spain	Novartis Investigative Site	Baleares
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	El Palmar (Murcia)
Spain	Novartis Investigative Site	Galdakano	Pais Vasco
Spain	Novartis Investigative Site	Garanada	Andalucia
Spain	Novartis Investigative Site	Hospitalet de Llobregat	Barcelona
Spain	Novartis Investigative Site	Jerez de la Frontera	Andalucia
Spain	Novartis Investigative Site	Las Palmas de Gran Canaria	Las Palmas De G.C
Spain	Novartis Investigative Site	Las Palmas de Gran Canaria
Spain	Novartis Investigative Site	Las Palmas de Gran Canaria
Spain	Novartis Investigative Site	Lleida	Cataluna
Spain	Novartis Investigative Site	Logrono	La Rioja
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Majadahonda	Madrid
Spain	Novartis Investigative Site	Marbella	Malaga
Spain	Novartis Investigative Site	Pamplona	Navarra
Spain	Novartis Investigative Site	Pontevedra	Galicia
Spain	Novartis Investigative Site	Salamanca
Spain	Novartis Investigative Site	Salt	Cataluña
Spain	Novartis Investigative Site	San Sebastian de los Reyes	Madrid
Spain	Novartis Investigative Site	San Sebastian de los Reyes	Madrid
Spain	Novartis Investigative Site	Santander	Cantabria
Spain	Novartis Investigative Site	Sevilla
Spain	Novartis Investigative Site	Sevilla
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Torrelavega	Cantabria
Spain	Novartis Investigative Site	Utrera	Andalucia
Spain	Novartis Investigative Site	Villamartin	Cadiz
Spain	Novartis Investigative Site	Zaragoza
Spain	Novartis Investigative Site	Zaragoza
Switzerland	Novartis Investigative Site	Luzern	LU
United Arab Emirates	Novartis Investigative Site	Abu Dhabi
United Arab Emirates	Novartis Investigative Site	Ras Al Khaimah
United States	Novartis Investigative Site	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Brazil,  Croatia,  Cyprus,  France,  Germany,  Greece,  Ireland,  Lebanon,  Malta,  Panama,  Philippines,  Slovenia,  Spain,  Switzerland,  United Arab Emirates,