Sickle Cell DiseaseNCT03720626
Managed Access Programs for SEG101, Crizanlizumab
A study testing crizanlizumab in people with Sickle Cell Disease, run by Novartis Pharmaceuticals.
Trial summary
The purpose of this registration is to list Managed Access Programs (MAPs) related to SEG101, Crizanlizumab Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- crizanlizumab
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
IInclusion Criteria:
An independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
The patient is not eligible or able to enrol in a clinical trial or continue participation in such 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 the country of request (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.
Trial locations and contacts
No sites are listed yet.
MAP requests are initiated by a licensed physician. https// www.novart is.com/healthcare-professionals/managed-access-programs contact
Novartis Pharmaceuticals contact
About this study
The purpose of this registration is to list Managed Access Programs (MAPs) related to SEG101, Crizanlizumab
Read the detailed description
CSEG101A2001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CSEG101A2001M to provide access to Crizanlizumab for sickle cell disease patients with history of vaso-occlusive crisis
- Conditions
- Sickle Cell Disease
- Being tested
- crizanlizumab
- Keywords
- MAP, Managed Access Program, SEG101, Crizanlizumab
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crizanlizumabDrug
Also called SEG101
Patients receive crizanlizumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720626
- Sponsor's protocol ID
- CSEG101A2001M
- Status last verified
- Apr 2026
- First submitted
- 24 Oct 2018
- Last updated
- 14 Apr 2026
- Results posted
- No
Publications
DeBonnett L, Joshi V, Silva-Pinto AC, Colombatti R, Pasanisi A, Arcioni F, Cancado RD, Sarp S, Sarkar R, Soliman W. Real-World Evidence of Crizanlizumab Showing Reductions in Vaso-Occlusive Crises and Opioid Usage in Sickle Cell Disease. Eur J Haematol. 2025 Feb;114(2):293-302. doi: 10.1111/ejh.14323. Epub 2024 Oct 29.
PubMed 39473076
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managed Access Programs for SEG101, Crizanlizumab
- ClinicalTrials.gov ID
- NCT03720626
- Acronym / sponsor ID
- CSEG101A2001M
- Conditions
- Sickle Cell Disease
- Keywords
- MAP, Managed Access Program, SEG101, Crizanlizumab
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this registration is to list Managed Access Programs (MAPs) related to SEG101, Crizanlizumab
Detailed description
CSEG101A2001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CSEG101A2001M to provide access to Crizanlizumab for sickle cell disease patients with history of vaso-occlusive crisis
Study design
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| crizanlizumabAlso: SEG101Patients receive crizanlizumab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Derived from this study: PubMed 39473076DeBonnett L, Joshi V, Silva-Pinto AC, Colombatti R, Pasanisi A, Arcioni F, Cancado RD, Sarp S, Sarkar R, Soliman W. Real-World Evidence of Crizanlizumab Showing Reductions in Vaso-Occlusive Crises and Opioid Usage in Sickle Cell Disease. Eur J Haematol. 2025 Feb;114(2):293-302. doi: 10.1111/ejh.14323. Epub 2024 Oct 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MAP requests are initiated by a licensed physician. https// www.novart is.com/healthcare-professionals/managed-access-programs contact
Novartis Pharmaceuticals contact
Questions about this trial
What is this clinical trial studying?
A study testing crizanlizumab in people with Sickle Cell Disease, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MAP requests are initiated by a licensed physician. https// www.novart is.com/healthcare-professionals/managed-access-programs (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03720626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.