A Phase 4 Study of Crizanlizumab Treatment for Patients with Sickle Cell Disease Who Previously Participated in Novartis Clinical Trials

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What is this study about?

This study focuses on Sickle Cell Disease, a condition where red blood cells become crescent-shaped and can block blood vessels, causing pain and other complications. The study will use crizanlizumab, which is given through an intravenous infusion (delivered directly into a vein). This medication is designed to help prevent blood cells from sticking together and forming blockages in blood vessels.

The purpose of this research is to continue providing crizanlizumab treatment to patients with Sickle Cell Disease who have previously participated in other studies of this medication. The treatment will be administered through an intravenous line every few weeks, with each dose calculated based on the patient’s weight. The maximum dose will be 7.5 milligrams per kilogram of body weight.

During the study, which may last up to 120 months, patients will receive regular infusions of crizanlizumab. The medical team will monitor the patients’ health and track any side effects that may occur during the treatment. This monitoring will help ensure patient safety throughout the study period.

1 Initial treatment phase

You will receive crizanlizumab (SEG101) through an intravenous infusion (medication given directly into a vein)

The medication comes as a concentrate that will be prepared as a solution for your infusion

2 Regular treatment visits

Your participation requires regular visits for infusion treatments

Each visit includes monitoring of your sickle cell disease condition

Healthcare providers will track any side effects or reactions to the treatment

3 Ongoing monitoring

Healthcare providers will monitor the frequency and severity of any treatment-related effects

Regular assessments will evaluate how your body responds to the medication

The study continues until June 2031

4 Safety assessments

Throughout the study, your health status will be regularly evaluated

Any changes in your condition or new symptoms will be documented

The medical team will assess if any health changes are related to the treatment

5 Study completion

The study continues as long as you benefit from the treatment

Regular evaluations will determine if continuing treatment remains appropriate for your condition

The study is scheduled to end in June 2031

Who Can Join the Study?

  • Must be an adult patient able to provide written consent according to local guidelines
  • Must have sickle cell disease (SCD) – a condition where red blood cells become hard and form a crescent shape
  • Must be currently participating in and benefiting from a Novartis study where they receive crizanlizumab treatment
  • Must have completed all requirements of their current study
  • Must have shown good attendance at scheduled study visits
  • Must be willing and able to continue attending future scheduled visits
  • Can be either male or female
  • Must be at least 18 years old

Who Cannot Join the Study?

  • Patients who are not currently receiving crizanlizumab treatment in a Novartis-sponsored study
  • Patients who do not have a confirmed diagnosis of sickle cell disease (a genetic blood disorder that affects red blood cells)
  • Patients who are not able to provide informed consent
  • Pregnant or breastfeeding women
  • Patients with severe allergic reactions to crizanlizumab or any of its components
  • Patients with severe organ damage or dysfunction
  • Patients participating in other clinical trials
  • Patients unable to comply with study procedures and follow-up visits
  • Patients with uncontrolled medical conditions that could interfere with the study
  • Patients who have previously discontinued crizanlizumab treatment due to safety concerns

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hopital Necker Enfants Malades Paris France
Universitaetsklinikum Heidelberg AöR Heidelberg Germany

Other Sites

Site Name City Country Status
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Azienda Ospedaliera di Padova Padua Italy
University Childrens Hospital Queen Fabiola Brussels Belgium
Hfjrgyvj Vqip difhhdqo Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
10.06.2021
France France
Not recruiting
10.06.2021
Germany Germany
Not recruiting
10.06.2021
Italy Italy
Not recruiting
10.06.2021
Spain Spain
Not recruiting
10.06.2021

Trial locations

Investigated drugs:

Crizanlizumab is a medication used to treat sickle cell disease (SCD). It works by helping to prevent blood cells from sticking together and forming clots, which can cause pain and other complications in people with sickle cell disease. This medication is given through an intravenous (IV) infusion, which means it’s delivered directly into the bloodstream through a vein.

Investigated diseases:

Sickle Cell Disease – A genetic blood disorder where red blood cells become rigid and take on a crescent or sickle shape instead of their normal round form. This inherited condition affects hemoglobin, the protein in red blood cells that carries oxygen throughout the body. The abnormal cells can get stuck in small blood vessels, causing pain and reducing blood flow to various parts of the body. The misshapen cells also break down more quickly than normal blood cells, which leads to anemia. People with this condition can experience periodic episodes called pain crises when blood flow becomes blocked to an area of the body. The disease is present from birth but symptoms usually begin to appear in early childhood.

Trial ID:
2024-510734-41-00
Protocol code:
CSEG101A2401B
NCT ID:
NCT04657822
Trial Phase:
Therapeutic confirmatory (Phase III)

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