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A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

NCT ID: NCT04557462

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2032-10-25

Brief Summary

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The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.

Detailed Description

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This is an open-label, non-randomized, multicenter roll-over extension program (REP) to:

* CLNP023X2203, a Phase II trial investigating the dose ranging effects of LNP023 on efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability in primary IgAN patients, and
* CLNP023A2301, a Phase III trial, investigating the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of LNP023 in patients with primary IgAN.

Subjects completing the CLNP023X2203 and CLNP023A2301 trials on study drug, who want to continue treatment and who meet the inclusion/exclusion requirements of the roll over extension program, will have the opportunity to receive iptacopan until:

* 3 years from LPFV of this study CLNP023A2002B, or
* the participant no longer derives benefit from iptacopan according to the Investigator, or
* the benefit-risk profile of the product in IgAN is no longer positive, or
* initiation of maintenance hemodialysis, kidney transplantation or eGFR \< 15 mL/min/1.73m2 , or
* the product becomes commercially available in a specific country following product launch and subsequent reimbursement for IgAN, where applicable, or
* if a marketing application or reimbursement of an investigational product is rejected/not pursued in a region/country for the indication under study or which ever is sooner

Conditions

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Primary IgA Nephropathy

Keywords

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Immunoglobulin A nephropathy Primary IgA nephropathy IgAN chronic kidney disease glomerulonephritis complement alternative pathway eGFR UPCR UACR LNP023

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LNP023

All participants are receiving 200 mg b.i.d

Group Type EXPERIMENTAL

LNP023

Intervention Type DRUG

Capsule 200 mg (b.i.d.) taken orally twice a day

Interventions

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LNP023

Capsule 200 mg (b.i.d.) taken orally twice a day

Intervention Type DRUG

Other Intervention Names

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iptacopan

Eligibility Criteria

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Inclusion Criteria

* For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment period.
* eGFR\* ≥ 20 ml/min/1.73m2

\*eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)
* Per investigator's clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d.
* Prior Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations.
* All participants must be on supportive care regimen of ACEi or ARB\* as per KDIGO guidelines.

* participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study

Exclusion Criteria

* participants who screen or baseline failed in the CLNP023X2203 Part 1 or Part 2, or CLNP023A2301 studies or who prematurely withdrew from either study for any reason.
* Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with LNP023.
* Current (within 4 weeks of study drug administration in the REP) acute kidney injury (AKI)
* Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.
* Participants treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus and/or systemic corticosteroids exposure (\>7.5 mg/d prednisone/prednisolone equivalent) within 5 half-lives of respective medication or 90 days prior to first study drug administration, whichever is shorter. Rituximab requires 180 days wash out.
* Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 30 days whichever is longer.
* History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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AZ Kidney Dise and Hypertension Ctr

Glendale, Arizona, United States

Site Status RECRUITING

Kaiser Permanente

San Diego, California, United States

Site Status ACTIVE_NOT_RECRUITING

North America Research Institute

San Dimas, California, United States

Site Status ACTIVE_NOT_RECRUITING

University of Colorado Anschutz

Aurora, Colorado, United States

Site Status ACTIVE_NOT_RECRUITING

Nephrology Associates PA

Newark, Delaware, United States

Site Status WITHDRAWN

CaRe Research

Chubbuck, Idaho, United States

Site Status ACTIVE_NOT_RECRUITING

Nep Assoc of Northern Illinois

Hinsdale, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Brigham and Womens Hosp Harvard Med School

Boston, Massachusetts, United States

Site Status RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Clin Rsrch Consult a JCCT Company

Kansas City, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

DaVita Clinical Research

Las Vegas, Nevada, United States

Site Status ACTIVE_NOT_RECRUITING

New Jersey Kidney Care

Jersey City, New Jersey, United States

Site Status ACTIVE_NOT_RECRUITING

Col Uni Med Center New York Presby

New York, New York, United States

Site Status RECRUITING

Dallas Renal Group

Dallas, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Prolato Clinical Research Center

Houston, Texas, United States

Site Status WITHDRAWN

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

CABA, , Argentina

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

CABA, , Argentina

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Santa Fe, , Argentina

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Woolloongabba, Queensland, Australia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Adelaide, South Australia, Australia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Parkville, Victoria, Australia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Roeselare, West-Vlaanderen, Belgium

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Edegem, , Belgium

Site Status RECRUITING

Novartis Investigative Site

Leuven, , Belgium

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Curitiba, Paraná, Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Sao Jose Rio Preto, , Brazil

Site Status RECRUITING

Novartis Investigative Site

Oshawa, Ontario, Canada

Site Status WITHDRAWN

Novartis Investigative Site

Temuco, , Chile

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Beijing, Beijing Municipality, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Beijing, Beijing Municipality, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Luoyang, Henan, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Zhengzhou, Henan, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Changsha, Hunan, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Changchun, Jilin, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Yinchuan, Ningxia, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Taiyuan, Shanxi, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Xian, Shanxi, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Ürümqi, Xinjiang, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Ningbo, Zhejiang, China

Site Status RECRUITING

Novartis Investigative Site

Wenzhou, Zhejiang, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Guangzhou, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Ningbo, , China

Site Status RECRUITING

Novartis Investigative Site

Qingdao, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Shanghai, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Shanghai, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Shenzhen, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Medellín, Antioquia, Colombia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Site Status RECRUITING

Novartis Investigative Site

Prague, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Aalborg, , Denmark

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Aarhus N, , Denmark

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Copenhagen, , Denmark

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Odense C, , Denmark

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Marseille, , France

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Montpellier, , France

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Paris, , France

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Stuttgart, Baden-Wurttemberg, Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Aachen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Essen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Hanover, , Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Heidelberg, , Germany

Site Status WITHDRAWN

Novartis Investigative Site

Kiel, , Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Magdeburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Mainz, , Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Tübingen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Ulm, , Germany

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Hong Kong, Hong Kong, Hong Kong

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Pécs, Baranya, Hungary

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bangalore, Karnataka, India

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, India

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, India

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Hyderabad, Telangana, India

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Ashkelon, , Israel

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Jerusalem, , Israel

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Petah Tikva, , Israel

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bologna, BO, Italy

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Napoli, , Italy

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Kasugai, Aichi-ken, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Toyoake, Aichi-ken, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Toyota, Aichi-ken, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Kawasaki, Kanagawa, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Yokohama, Kanagawa-ku, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Kyoto, Kyoto, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Sendai, Miyagi, Japan

Site Status WITHDRAWN

Novartis Investigative Site

Matsumoto, Nagano, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Ōmihachiman, Shiga, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Chiba, , Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Niigata, , Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Okayama, , Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Osaka, , Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Osaka, , Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Kuala Lumpur, , Malaysia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Mexico City, , Mexico

Site Status RECRUITING

Novartis Investigative Site

Querétaro, , Mexico

Site Status RECRUITING

Novartis Investigative Site

Groningen, Provincie Groningen, Netherlands

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Nordbyhagen, Oslo County, Norway

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bergen, , Norway

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Rostov-on-Don, , Russia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Košice, , Slovakia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Maribor, Slovenia, Slovenia

Site Status WITHDRAWN

Novartis Investigative Site

Ljubljana, , Slovenia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bloemfontein, Free State, South Africa

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, South Korea

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status COMPLETED

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Cheongju-si, North Chungcheong, South Korea

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Busan, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Taegu, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Pamplona, Navarre, Spain

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Barcelona, , Spain

Site Status RECRUITING

Novartis Investigative Site

Salamanca, , Spain

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Stockholm, , Sweden

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Kaohsiung City, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

New Taipei City, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

New Taipei City, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Taichung, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Taichung, , Taiwan

Site Status COMPLETED

Novartis Investigative Site

Taipei, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Taoyuan District, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bangkok, , Thailand

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bangkok, , Thailand

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bangkok, , Thailand

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Köseköy, Kocaeli, Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Antalya, Konyaalti, Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Kayseri, Melikgazi, Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Istanbul, Sariyer, Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Mersin, Yenisehir, Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Cambridge, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Leicester, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

London, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Salford, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Ho Chi Minh City, VNM, Vietnam

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Ho Chi Minh City, , Vietnam

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States Argentina Australia Belgium Brazil Canada Chile China Colombia Czechia Denmark France Germany Hong Kong Hungary India Israel Italy Japan Malaysia Mexico Netherlands Norway Russia Singapore Slovakia Slovenia South Africa South Korea Spain Sweden Taiwan Thailand Turkey (Türkiye) United Kingdom Vietnam

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Facility Contacts

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Mira Sedor

Role: primary

Kristin Lyman

Role: primary

Valentina Castro

Role: primary

Shan Luc-Kenney

Role: primary

Anup Pradhan

Role: primary

Other Identifiers

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2020-002200-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLNP023A2002B

Identifier Type: -

Identifier Source: org_study_id