ClinicaliQ Trial Snapshot
- A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials — Recruiting • Phase III • Oncology • NCT04064060.
- What is being tested: Long-term safety profile of luspatercept (ACE-536) in patients transitioning from completed or concluded parent clinical trials, using an open-label rollover study design to monitor sustained tolerability and adverse events.
- Patient eligibility overview: Participants must have been actively receiving luspatercept in a parent protocol and demonstrate adequate tolerance of the protocol-prescribed dosing regimen at the point of transition to this extension study.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants: * Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept * Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up…
Eligibility Snapshot
- : Participants must meet all the following criteria to be enrolled in this study:
- Participant is ≥ 18 years at the time of signing the informed consent form (ICF).
- Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
- Participant has been participating in a luspatercept trial and continues to fulfill all the requirements of the parent protocol and the participant has been either: 1. Assigned to luspatercept treatment, continues to receive clinical benefit in the opinion of the investigator and should continue to receive luspatercept treatment, OR 2. Assigned to placebo arm in the parent protocol (at the time of unblinding or in follow-up) and should cross over to luspatercept treatment, OR 3. Assigned to the Follow-up Phase of the parent protocol, previously treated with luspatercept or placebo in the parent protocol who shall continue into LTPTFU phase in the rollover study until the follow-up commitments are met (unless requirements are met as per parent protocol to crossover to luspatercept treatment).
- Participant understands and voluntarily signs an informed consent document prior to any study-related assessments or procedures being conducted.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.