Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

Launched by NOVARTIS PHARMACEUTICALS · Dec 1, 2020

Keywords

ClinConnect Summary

This clinical trial is a rollover study for patients with Sickle Cell Disease (SCD) who have previously participated in a study sponsored by Novartis and have been receiving a medication called crizanlizumab. The main goal of this trial is to allow these patients to continue their treatment with crizanlizumab if they have been benefiting from it, as determined by their doctor. This study is currently recruiting participants aged 18 and older, and anyone who is currently on crizanlizumab and has followed the treatment schedule in the earlier study may be eligible to join.

To participate, patients need to provide written consent, and if they are under 18, their parents or guardians must sign for them. They should not have stopped the crizanlizumab treatment early in the previous study, and they should be free from serious side effects from the medication. During this trial, participants can expect regular check-ups and continued access to the crizanlizumab treatment, which may help manage their SCD symptoms. It's important to note that pregnant or nursing women, as well as those taking part in other clinical trials, are not eligible to join this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent/assent, according to local guidelines, signed by the adult patients. In the population under 18 years, it will be signed by the patient and/or by the parents or legal guardian prior to enrolling in the rollover study and receiving study medication
• • 2. SCD patient currently enrolled in a Novartis-sponsored study receiving crizanlizumab and has fulfilled all the requirements in the parent study. Patient is currently benefiting from the treatment with crizanlizumab as determined by the investigator and has completed the treatment schedule as planned in the parent study
• • 3. Patient has demonstrated compliance to the planned visit schedule in the parent study, and in the opinion of the investigator has shown willingness and ability to comply with future visit schedules
• Exclusion Criteria:
• • 1. Patient had permanently discontinued from crizanlizumab study treatment in the parent study before the parent study completion
• • 2. Ongoing/unresolved treatment-related Grade 3 or higher AEs, and/or any ongoing AE requiring dose interruption. Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved unless those toxicities were grade 4
• • 3. Concurrent participation in any other investigational clinical trial other than the parent study or plan to participate in any other investigational clinical trial
• • 4. Pregnant or nursing women
• • 5. Women of childbearing potential who are unwilling to be on highly effective contraceptives during dosing and until 15 weeks after stopping treatment with crizanlizumab
• • 6. SCD patients who do not meet parent study protocol criteria to continue with crizanlizumab