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An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia

NCT02604433 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2023-04-18

Study results available
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Summary

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) plus Best supportive care (BSC) versus placebo plus BSC in adults who require regular red blood cell transfusion due to (β)-thalassemia.

The study is divided into the following periods:

* Historical Period,
* Screening/Run-in Period,
* Double-blind Treatment Period (48 weeks),
* Double-blind Long-term Treatment Period, (at the investigator's discretion an additional 48 weeks),
* Open-Label Phase post unblinding and upon Data Monitoring Committee positive recommendation
* Post-treatment Follow-up Period

Conditions

Interventions

DRUG

Luspatercept

Subjects will start with luspatercept at 1 mg/kg dose level.

OTHER

Placebo

Placebo, Subcutaneous, every 21 days.

Sponsors & Collaborators

  • Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

    collaborator INDUSTRY

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-02
Primary Completion
2021-01-05
Completion
2021-01-05

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • France
  • Greece
  • Israel
  • Italy
  • Lebanon
  • Malaysia
  • Taiwan
  • Thailand
  • Tunisia
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02604433 on ClinicalTrials.gov