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Recruiting NCT07215975

A Real-World Study to Evaluate Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East

— Observational β-thalassemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Luspatercept.
Who it may be relevant to
Registry conditions: β-thalassemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Oman, Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

REal-World Application of Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East (RELATE): A Non-interventional Retrospective and Prospective Observational Study

Overview

The purpose of this study is to evaluate luspatercept treatment in adults with transfusion-dependent beta-Thalassemia in the Middle East

Interventions

  • Drug Luspatercept
    According to the product label

Primary outcome measures

  • Change in transfusion burden [Time frame: Baseline and up to week 144]
  • Change in mean pre-transfusion hemoglobin level [Time frame: Baseline and up to week 144]
Secondary outcome measures (12)
  • Change in transfusion-related visits [Time frame: Baseline and up to week 144]
  • Proportion of participants achieving ≥33% reduction in red blood cell (RBC) transfusion burden (number of RBC units transfused) plus a reduction of ≥2 units [Time frame: Baseline and up to week 144]
  • Proportion of participants achieving ≥50% reduction in red blood cell transfusion burden plus a reduction of ≥2 units [Time frame: Baseline and up to week 144]
  • Time from first luspatercept dosing date to the first erythroid response [Time frame: Baseline and up to week 144]
  • Time from the date the erythroid response is first observed until the last day of response [Time frame: Baseline and up to week 144]
  • Participant pretransfusion hemoglobin level [Time frame: Baseline and up to week 144]
  • Participant baseline transfusion burden [Time frame: Baseline]
  • Proportion of participants without red blood cell transfusion during any consecutive 12-week or 24-week treatment period [Time frame: Baseline and up to week 144]
  • Time from first luspatercept dosing date to first onset of red blood cell-transfusion independence ≥12 weeks and ≥24 weeks [Time frame: Baseline and up to week 144]
  • Time from the date a 12-week and 24-week red blood cell-transfusion independence is first observed until the date the participant has a subsequently documented red blood cell transfusion [Time frame: Baseline and up to week 144]
  • Change in mean serum ferritin (SF) level [Time frame: Baseline and up to week 144]
  • Change in proportion of participants with mean serum ferritin <1,000, 1000-2500, and >2,500 μg/L [Time frame: Baseline and up to week 144]

Eligibility criteria

Inclusion criteria

  • Male or female participants of any race aged at least 18 years at time of initiation of luspatercept treatment
  • Participants with documented diagnosis of transfusion-dependent β-thalassemia (TDT).
  • Participants who have been initiated on treatment with luspatercept as per the product's Summary of Product Characteristics (SmPC) no longer than 12 months prior to informed consent signature, and for whom therapy is ongoing.
  • Participants for whom the decision to prescribe luspatercept treatment is clearly separated from the physician's decision to include the participant in the current study.
  • Participants who have provided signed informed consent for participating in the study and for collecting and analyzing medical data pertinent to the objectives of this study

Exclusion criteria

  • Participants that meet any of the contraindications to the administration of luspatercept as outlined in the latest version of the locally approved SmPC.
  • Participants who are currently receiving or are planned to receive treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to luspatercept therapy initiation.
  • Participants who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period.
  • Participants who have not provided signed informed consent for participating in the study and for collecting and analysing medical data pertinent to the objectives of this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Oman · 1 center
  • Sultan Qaboos University Hospital — Seeb
Saudi Arabia · 1 center
  • Prince Muhammad bin Nasser Hospital — Jizan

Identifiers

NCT: NCT07215975 · CA056-1107

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗