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Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

342,868 studies
in
216 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.
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Clinical Trials of Interest

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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.
Displaying: 13 trials in your specialties ()
View trials across your selected specialties

A Safety and Efficacy Study to Evaluate Luspatercept in Subjects With Myeloproliferative Neoplasm-associated Myelofibrosis Who Have Anemia With and Without Red Blood Cell-transfusion Dependence

  • Status
    Recruiting
  • Phase
    Phase 2
  • Condition
    Primary Myelofibrosis, Anemia
View Full Trial
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Mayo Clinic - Arizona, Phoenix, Arizona, United States

Brief Summary

This is a Phase 2, multicenter, open-label study to evaluate the efficacy and safety of luspatercept in subjects with MPN-associated myelofibrosis and anemia with and without RBC-transfusion dependence. The study is divided into a Screening Period, a Treatment Period (consisting of a Primary Phase, a Day 169 Disease Response Assessment, and an Extension Phase), followed by a Posttreatment Follow-up Period.

ACE-536 Extension Study - Myelodysplastic Syndromes

  • Status
    Active, not recruiting
  • Phase
    Phase 2
  • Condition
    Myelodysplastic Syndromes
View Full Trial
INTERVENTION

Drug: ACE-536

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Acceleron Investigative Site, Dresden, Germany

Brief Summary

Study A536-05 is an open-label extension study for patients previously enrolled in study A536-03 (ClinicalTrials.gov Identifier NCT01749514), to evaluate the long-term safety and tolerability of ACE-536 in patients with low or intermediate-1 risk MDS.

ACE-536 Extension Study - Beta Thalassemia

  • Status
    Active, not recruiting
  • Phase
    Phase 2
  • Condition
    Beta-Thalassemia
View Full Trial
INTERVENTION

Drug: ACE-536

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Acceleron Investigative Site, Athens, Greece

Brief Summary

Study A536-06 is an open-label extension study for patients previously enrolled in study A536-04 (ClinicalTrials.gov Identifier NCT01749540), to evaluate the long-term safety and tolerability of ACE-536 in adult patients with beta-thalassemia.

Study of Safety & PK of Luspatercept (ACE-536) in Pediatric Subjects Who Require Regular RBC Transfusions Due to Beta (β)-Thalassemia.

  • Status
    Recruiting
  • Phase
    Phase 2
  • Condition
    Beta-Thalassemia
View Full Trial
INTERVENTION

Drug: ACE-536, Drug: ACE-536

Eligibility
  • Ages: 6 to 18 Months (Child)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Children's Hospital of Los Angeles, Los Angeles, California, United States

Brief Summary

This is a Phase 2a study to evaluate the safety and pharmacokinetics (PK) of luspatercept in pediatric subjects who require regular RBC transfusions due to β-thalassemia. At least 12 subjects are planned to be enrolled per each of the 4 age-group strata at 2 different dose levels. Any subject benefiting from the study treatment (at the Investigator's discretion), at the completion of the Treatment Period, will be offered the opportunity to continue luspatercept and long-term follow-up in the Long-term Treatment and Follow-up Period. Subjects entering the Long-term Treatment and Follow-up Period will continue to receive luspatercept at the same dose level as during the Treatment Period for up to 5 years from their first dose (Cycle 1 Day 1) or when the drug is approved for pediatric patients (whichever comes first). Subjects who receive treatment for the full 5 years will then have an End of Treatment visit and then a Post End of Treatment visit (12 weeks from last dose). Any subject that discontinues treatment prior to 5 years from Cycle 1 Day 1 will be have an End of Treatment visit, a Post End of Treatment visit (12 weeks from last dose), and then will continue in Long-Term Posttreatment Follow-up until 5 years from Cycle 1 Day 1 or until they withdraw consent/assent, are lost to follow-up, or the End of Trial, whichever occurs first.

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

  • Status
    Active, not recruiting
  • Phase
    Phase 3
  • Condition
    Erythrocyte Transfusion, Beta-Thalassemia
View Full Trial
INTERVENTION

Other: Placebo, Drug: Luspatercept

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Children's Hospital of Los Angeles, Los Angeles, California, United States

Brief 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

An Efficacy and Safety Study of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in Japanese Subjects Who Are Not Requiring Red Blood Cell Transfusion

  • Status
    Recruiting
  • Phase
    Phase 2
  • Condition
    Myelodysplastic Syndromes
View Full Trial
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages: 20 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

National Hospital Organization Kyushu Medical Center, Fukuoka, Japan

Brief Summary

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a Phase 2, multicenter, single-arm study to evaluate the efficacy, safety and Pharmacokinetics (PK) of luspatercept (ACE-536) for the treatment of anemia due to International prognostic scoring system-Revised (IPSS-R) very low, low or intermediate risk Myelodysplastic syndromes (MDS)in Japanese subjects who are not requiring Red blood cell (RBC) transfusion. The study is divided into the Screening Period, a Treatment Period and a Post-Treatment Follow up Period.

A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes

  • Status
    Active, not recruiting
  • Phase
    Phase 3
  • Condition
    Myelodysplastic Syndromes
View Full Trial
INTERVENTION

Drug: Luspatercept, Other: Placebo

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Stanford Cancer Center, Stanford, California, United States

Brief Summary

The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in subjects with anemia due to IPSS-R very low, low, or intermediate MDS with ring sideroblasts who require RBC transfusions.

A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (β)-Thalassemia

  • Status
    Active, not recruiting
  • Phase
    Phase 2
  • Condition
    Thalassemia
View Full Trial
INTERVENTION

Drug: Luspatercept, Other: Placebo, Other: Best Supportive Care (BSC)

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Children's Hospital of Los Angeles, Los Angeles, California, United States

Brief Summary

This is a Phase 2, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in adults with non-transfusion dependent beta (β)-thalassemia. The study is divided into the Screening Period, Double-blind Treatment Period (DBTP) and Post-Treatment Follow-up Period (PTFP). It is planned to randomize approximately 150 subjects at a 2:1 ratio of luspatercept versus placebo.

A Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Myelodysplastic Syndromes (MDS), Beta-thalassemia, Myeloprolifera...
View Full Trial
INTERVENTION

Drug: Luspatercept

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Childrens Hospital Los Angeles RHU, Los Angeles, California, United States

Brief Summary

A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following subjects: - Subjects 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 in the opinion of the investigator from continuing treatment with luspatercept. - Placebo arm subjects from parent protocol (at the time of unblinding or in follow-up) crossing over to luspatercept treatment (provided subjects have met all requirements for entering the rollover study as per the parent protocol). - Subjects 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 commitments are met (unless they meet requirements as per parent protocol to cross-over to luspatercept treatment). The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Subjects will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase. - Transition Phase (Screening): up to 21 days prior to enrollment - Treatment Phase: For subjects in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. For placebo arm subjects from parent protocol (at the time of unblinding or in follow-up) crossing over to luspatercept treatment (provided subjects have met all requirements for entering the rollover study as per the parent protocol) will start at a luspatercept dose of 1.0 mg/kg every 3 weeks (Q3W). This does not apply to subjects that are in long-term follow-up from the parent protocol. - Follow-up Phase: - 42 Day Safety Follow-up Phase: subjects will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting. - Long-term Post-treatment Follow-up (LTPTFU) Phase: All subjects who are continuing in the LTPTFU Phase, will continue to be followed for 5 years from Dose 1 of the parent protocol, or 3 years of post-treatment from last dose of the parent protocol, whichever occurs later. Subjects will be followed every 6 months until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Subjects will also be monitored for progression to AML or any malignancies/pre- malignancies. New anticancer or disease related therapies should be collected at the same time schedule. Subjects transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study. The rollover study will be terminated, and relevant subjects will discontinue from the study when all subjects fulfill 5 years from Dose 1 of the parent protocol, or 3 years of post-treatment from last dose of the parent protocol, whichever occurs later. The shift to commercial drug is an alternative way to stop the study.

Efficacy and Safety Study of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Myelodysplastic Syndromes
View Full Trial
INTERVENTION

Drug: Luspatercept, Drug: Epoetin alfa

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Alabama Oncology - Grandview Cancer Center, Birmingham, Alabama, United States

Brief Summary

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is an interventional active-controlled, open-label, randomized Phase 3 study to compare the efficacy and safety of luspatercept (ACE-536) versus epoetin alfa for the treatment of anemia due to IPSS-R very low, low or intermediate risk MDS in ESA naïve subjects who require RBC transfusions. The study is divided into the Screening Period, a Treatment Period and a Post-Treatment Follow-up Period.