- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05222412
Managed Access Programs for LNP023, Iptacopan
February 7, 2024 updated by: Novartis Pharmaceuticals
The purpose of this registration form is to list all Managed Access Programs (MAPs) related to LNP023, Iptacopan
Study Overview
Status
Available
Intervention / Treatment
Detailed Description
- CLNP023B12004M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023B12004M to Provide Access to Iptacopan (LNP023) for Complement 3 Glomerulopathy in Native and Transplanted Kidneys.
- CLNP023N12001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023N12001M to provide access to Iptacopan for patients with paroxysmal nocturnal hemoglobinuria (PNH).
Study Type
Expanded Access
Expanded Access Type
- Intermediate-size Population
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Novartis Pharmaceuticals
- Phone Number: +41613241111
Study Contact Backup
- Name: MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs
- Phone Number: 1-888-669-6682
- Email: novartis.email@novartis.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- An independent request should be received from a licensed physician (in some instances from Health Authorities, Institutions or Governments).
- The patient has a serious or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available for diagnosis, monitoring or treatment; patient is not medically eligible for available treatment alternatives or has exhausted all available treatment options.
- The patient is not eligible or able to enroll in a Novartis clinical trial or continue participation in a Novartis clinical trial.
- There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
- The patient must meet any other medical criteria established by the medical experts responsible for the product or by the Health Authority in a country (as applicable).
- Provision of the product will not interfere with the initiation, conduct or completion of a Novartis clinical trial or overall development program.
- Managed access provision is allowed per local laws/regulations.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
January 18, 2022
First Submitted That Met QC Criteria
January 18, 2022
First Posted (Actual)
February 3, 2022
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urologic Diseases
- Urological Manifestations
- Bone Marrow Diseases
- Hematologic Diseases
- Urination Disorders
- Anemia
- Proteinuria
- Anemia, Hemolytic
- Myelodysplastic Syndromes
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Hemoglobinuria
- Hemoglobinuria, Paroxysmal
Other Study ID Numbers
- CLNP023B12004M
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Paroxysmal Nocturnal Hemoglobinuria (PNH)
-
Apellis Pharmaceuticals, Inc.RecruitingParoxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal HemoglobinuriaMalaysia, United States, Czechia, France, Netherlands, Serbia, Spain, Thailand, United Kingdom
-
Novartis PharmaceuticalsCompletedParoxysmal Nocturnal Hemoglobinuria PNHLithuania, Japan, Czechia
-
Ra PharmaceuticalsCompletedParoxysmal Nocturnal Hemoglobinuria (PNH)United States
-
Alexion PharmaceuticalsAchillion, a wholly owned subsidiary of AlexionCompletedParoxysmal Nocturnal Hemoglobinuria (PNH)United Kingdom, New Zealand, Korea, Republic of, Italy
-
AKARI TherapeuticsCompletedParoxysmal Nocturnal Hemoglobinuria (PNH)Kazakhstan, Lithuania, Sri Lanka
-
Alexion PharmaceuticalsTerminatedParoxysmal Nocturnal Hemoglobinuria (PNH)United States, Czech Republic, Italy, Poland, United Kingdom
-
AlexionActive, not recruitingParoxysmal Nocturnal Hemoglobinuria (PNH)United Kingdom, Italy, Canada, Korea, Republic of, New Zealand, Spain, Turkey
-
AlexionCompletedParoxysmal Nocturnal Hemoglobinuria (PNH)Belgium, France, Italy, Japan, Spain, Taiwan, United Kingdom, United States, Canada, Czechia, Germany, Sweden, Singapore, Korea, Republic of, Russian Federation, Austria, Poland, Argentina, Australia, Brazil, Estonia, Malaysia, Mexico, Thaila... and more
-
Apellis Pharmaceuticals, Inc.CompletedParoxysmal Nocturnal Hemoglobinuria (PNH)United States
-
AlexionCompletedParoxysmal Nocturnal Hemoglobinuria (PNH)United States, Korea, Republic of, Canada, France, Germany, Spain, United Kingdom, Japan, Australia, Italy, Netherlands
Clinical Trials on Iptacopan
-
Novartis PharmaceuticalsRecruitingC3 GlomerulopathySpain, France, Germany, Switzerland, United States, Japan, Turkey, China, United Kingdom, Italy, Argentina, Brazil, Greece, Israel, Netherlands
-
Novartis PharmaceuticalsCompleted
-
Novartis PharmaceuticalsRecruitingLupus NephritisFrance, Spain, Israel, Turkey, United States, Germany, India, Hungary, Malaysia, Portugal, Brazil, China, Puerto Rico, Hong Kong, Mexico, Singapore
-
Novartis PharmaceuticalsActive, not recruitingImmune Thrombocytopenia (ITP) | Cold Agglutinin Disease (CAD)United States, Spain, Germany, Korea, Republic of, United Kingdom, Italy
-
Novartis PharmaceuticalsRecruitingAge-Related Macular DegenerationChina, United States, Puerto Rico, United Kingdom
-
Novartis PharmaceuticalsCompletedParoxysmal Nocturnal Hemoglobinuria (PNH)China, Germany, Singapore, Korea, Republic of, Italy, United Kingdom, Malaysia, France
-
Novartis PharmaceuticalsRecruitingAtypical Hemolytic Uremic SyndromeJapan, Turkey
-
Novartis PharmaceuticalsRecruitingC3GSpain, France, Switzerland, Germany, Greece, Turkey, Canada, India, United States, Czechia, Japan, Argentina, Brazil, Italy, Israel, United Kingdom, China, Belgium, Netherlands
-
Novartis PharmaceuticalsActive, not recruitingIgA NephropathyUnited States, Taiwan, Czechia, Germany, Hungary, India, Turkey, Belgium, Netherlands, Singapore, Australia, Canada, Italy, Korea, Republic of, Spain, Thailand, Denmark, Slovenia, United Kingdom, Argentina, Brazil, Israel, Japan, France, Swed... and more
-
Novartis PharmaceuticalsRecruitingParoxysmal Nocturnal HemoglobinuriaFrance, Spain, Italy, Turkey, Germany, United States, Korea, Republic of, United Kingdom