| NCT ID | NCT06748001 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Blueprint Medicines Corporation |
| Condition | Mastocytosis, Systemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-11-28 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2024-11-28 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of the rollover study is to evaluate the long-term safety of avapritinib in participants who have completed a Blueprint Medicines sponsored study (parent study) and continued to benefit from avapritinib.
Eligibility Criteria
Inclusion Criteria: * Participated in a Blueprint Medicines sponsored avapritinib clinical study. The Sponsor reserves the right to not roll over patients who have been on drug hold for an extended time period. * Completed End of Trial / End of Study (EOT/EOS) visit in the parent study and demonstrated compliance with the parent study requirements. * Continue to clinically benefit from treatment with avapritinib. * Able to give written informed consent. * Agree to continue to use highly effective contraception as defined in this protocol. * Female patients of childbearing potential must have negative highly sensitive serum pregnancy test within 20 days before the first dose of avapritinib. Women of nonchildbearing potential do not require this test. Exclusion Criteria: * Participant is participating in another interventional study. * Participant is unwilling or unable to comply with study procedures and study restrictions. * Participant is breastfeeding. Other protocol-defined criteria apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06748001 clinical trial?
This trial is open to participants of all sexes, studying Mastocytosis, Systemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06748001 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06748001 currently recruiting?
Yes, NCT06748001 is actively recruiting participants. Contact the research team at MedInfo@blueprintmedicines.com for enrollment information.
Where is the NCT06748001 trial being conducted?
This trial is being conducted at Edegem, Belgium, Toronto, Canada, Paris, France, Aachen, Germany and 6 additional locations.
Who is sponsoring the NCT06748001 clinical trial?
NCT06748001 is sponsored by Blueprint Medicines Corporation. The trial plans to enroll 60 participants.