A Study of AG-348 in Adult Participants With Pyruvate Kinase (PK) Deficiency

April 29, 2026 updated by: Agios Pharmaceuticals, Inc.

A Phase 2, Open Label, Randomized, Dose Ranging, Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of AG-348 in Adult Patients With Pyruvate Kinase Deficiency

Study AG348-C-003 is a multicenter study designed to evaluate the safety and efficacy of different dose levels of AG-348 (mitapivat) in participants with PK deficiency.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 2, open label, two arm, multicenter, randomized, dose-ranging study during which adult participants with PK deficiency will receive multiple doses of AG-348 for up to 24 weeks (Core Period); eligible participants may enter an Extension Period to receive AG-348 for up to 8 additional years. Data will be reviewed on a regular basis and study design, dose and schedule will be adapted based on these reviews. The study will evaluate the safety and tolerability of multiple doses of AG-348, pharmacokinetic and pharmacodynamic (PD) profile of AG-348 and early indicators of clinical efficacy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network
  • France
    • Nord
      • Lille, Nord, France, 59000
        • Hôpital Saint-Vincent de Paul
    • Île-de-France Region
      • Créteil, Île-de-France Region, France, 94010
        • Hopital Henri Mondor
  • Italy
      • Milan, Italy, 20122
        • UOC Oncoematologia Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht
  • United Kingdom
      • London, United Kingdom, W12 0NN
        • Hammersmith Hospital
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Boston Children's Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University School of Medicine - Children's Hospital of Michigan
    • New York
      • New York, New York, United States, 10065
        • New York Presbyterian Hospital- Weil Cornell Medical College
    • Pennsylvania
      • Belleville, Pennsylvania, United States, 17004
        • Central Pennsylvania Clinic
      • Philadelphia, Pennsylvania, United States, 19104
        • Children Hospital of Philadelphia (CHOP)
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Informed consent
  2. Male or female, aged 18 years and older
  3. Known medical history of PK deficiency
  4. PK deficiency confirmed by enzymatic assay at Screening
  5. Genotypic characterization of PKR gene at Screening
  6. Genotypic characterization of uridine-5'-diphosphate-glucuronyltransferase-A1 (UGTA1) gene to document underlying Gilbert's disease (Gilbert's disease patients are eligible)
  7. Males Hb ≤ 12.0 g/dL, females Hb ≤ 11 g/dL
  8. Transfusion independent, defined as no more than 3 units of red blood cells (RBC) transfused in 12 months prior to the first day of study dosing and no transfusions within 4 months of first day of study dosing
  9. Splenectomized patients must have had the procedure at least 6 months prior to Screening and must be up-to-date in recommended vaccinations
  10. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  11. Must be taking at least 1 mg folic acid daily in the 21 days prior to screening
  12. Adequate organ function defined by liver function, kidney function, platelet count and coagulation assessments
  13. Agreement to use approved contraceptive measures

  14. Women must not be breastfeeding

    For entry into the Extension Period, patients must meet criteria # 15-16:

  15. Must have completed 24 weeks of treatment during the Core Period and tolerated AG-348
  16. The treating Investigator agrees that there is a potential for clinical benefit to continued treatment and recommends participation in the Extension Period and the Medical Monitor approves

Exclusion criteria

  1. Hb ˃ 12.0 g/dL if male, Hb ˃11.0 g/dL if female
  2. Additional diagnosis of other congenital or acquired blood disorder
  3. Iron overload sufficiently severe to result in cardiac, hepatic or pancreatic insufficiency
  4. Bone marrow or stem cell transplant
  5. Clinically symptomatic cholelithiasis or cholecystitis
  6. Currently enrolled in any other investigational trial. Participation in the PK Deficiency Natural History Study (NCT02053480) is permitted
  7. Exposure to any investigational drug, device or procedure within 28 days prior to screening or during trial participation
  8. Concurrent medical condition such as poorly controlled hypertension, heart failure, active infection, frequent post-splenectomy sepsis, Hepatitis B or C, Human Immunodeficiency Virus type 1 (HIV1) or Human Immunodeficiency Virus type 2 (HIV2) infection, poorly controlled diabetes mellitus, history of primary malignancy with the exception of curatively treated nonmelanomatous skin cancer, cervical cancer of breast cancer in situ
  9. Major surgery in the last 6 months
  10. Psychiatric disorder that could compromise the ability of the patient to cooperate with the study
  11. Serum bilirubin higher to the upper limit of normal attributable to factors other than hemolysis or Gilbert's Syndrome
  12. Use of restricted products known to strongly inhibit cytochrome P450 (CYP) 3A4 metabolism within 5 days prior to Prior Day 1 dosing, or to strongly induce cytochrome P450 3A4 (CYP3A4) metabolism within 28 days prior to Day 1 dosing, or to strongly inhibit P-glycoprotein transporter within 5 days prior to Day 1 dosing, or digoxin within 5 days prior to Day 1 dosing.
  13. Heart-rate corrected QT interval - Fridericia's method (QTcF) interval ˃ 450 ms in male, QTcF > 470 ms in female, with the exception of patients with a left Bundle Branch Block
  14. Cardiac arrhythmias that are clinically significant or treated with drugs that are substrates of CYP3A4
  15. Allergy to sulfonamides if characterized by acute hemolytic anemia, anaphylaxis, rash of erythema multiforme type or Stevens-Johnson Syndrome
  16. Any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to participate in the study
  17. Patients will not be permitted to enter the Extension Period if: The patient experienced AEs during the Core Period that are considered by the treating Investigator or the Sponsor's designated Medical Monitor to pose a significant safety risk to the patient if treatment were to be extended

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AG-348 50 mg BID
Participants with Pyruvate Kinase (PK) deficiency will receive AG-348, 50 milligrams (mg), as initial dose, twice daily (BID) for 24 weeks (Core Period). Participants will be assigned to initial doses, however, over the course of the Core Period they will be treated across a range of doses due to treatment emergent adverse events (AEs) and hemoglobin (Hb) levels exceeding mid-point of sex-adjusted ranges. At the Week 24 visit, Core Period participants who have safely tolerated AG-348 and demonstrating clinical activity in response to AG-348 will be rolled over to the Extension Period. During the extension period, participants will continue to receive AG-348 50 mg, BID, for up to 102 months.
Drug: AG-348
Tablets
Other Names:
  • Mitapivat
Experimental: AG-348 300 mg BID
Participants with PK deficiency will receive AG-348, 300 mg, as initial dose, BID for 24 weeks (Core Period). Participants will be assigned to initial doses, however, over the course of the Core Period they will be treated across a range of doses due to treatment emergent AEs and Hb levels exceeding mid-point of sex-adjusted ranges. At the Week 24 visit, Core Period participants who have safely tolerated AG-348 and demonstrating clinical activity in response to AG-348 will be rolled over to the Extension Period. During the extension period, participants will continue to receive AG-348 300 mg, BID, up to 102 months.
Drug: AG-348
Tablets
Other Names:
  • Mitapivat

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Experiencing at Least One Adverse Event (AEs) in the Core Period
Time Frame: Up to Week 24
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered study drug-related.
Up to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin (Hb) Value at Week 24
Time Frame: Baseline and Week 24
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Increased Hb values indicate improvement.
Baseline and Week 24
Change From Baseline in Hematocrit at Week 24
Time Frame: Baseline and Week 24
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Increased hematocrit values indicate improvement.
Baseline and Week 24
Change From Baseline in Reticulocyte Count at Week 24
Time Frame: Baseline and Week 24
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased reticulocyte count values indicate improvement.
Baseline and Week 24
Change From Baseline in Haptoglobin at Week 24
Time Frame: Baseline and Week 24
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Increased haptoglobin values indicate improvement.
Baseline and Week 24
Change From Baseline in Lactate Dehydrogenase (LDH) at Week 24
Time Frame: Baseline and Week 24
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased LDH values indicate improvement.
Baseline and Week 24
Change From Baseline in Total Bilirubin at Week 24
Time Frame: Baseline and Week 24
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased total bilirubin values indicate improvement.
Baseline and Week 24
Change From Baseline in Indirect Bilirubin at Week 24
Time Frame: Baseline and Week 24
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased indirect bilirubin values indicate improvement.
Baseline and Week 24
Change From Baseline in Erythropoietin (EPO) at Week 24
Time Frame: Baseline and Week 24
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased EPO values indicate improvement.
Baseline and Week 24
Change From Baseline in Hepcidin at Week 24
Time Frame: Baseline and Week 24
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased hepcidin values indicate improvement.
Baseline and Week 24
Change From Baseline in Ferritin at Week 24
Time Frame: Baseline and Week 24
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased ferritin values indicate improvement.
Baseline and Week 24
Change From Baseline in Transferrin Saturation at Week 24
Time Frame: Baseline and Week 24
Transferrin saturation is the ratio of serum iron to iron-binding capacity. Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased transferrin saturation values indicate improvement.
Baseline and Week 24
Percentage of Participants Experiencing at Least One AE up to Month 102
Time Frame: Up to Month 102
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered study drug-related. Safety data for cumulative period (Core period and Extension period) has been reported in this outcome measure.
Up to Month 102
Change From Baseline Hb Value up to Month 102
Time Frame: Baseline, Months 12, 36, 60, 84, and 102
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Increased Hb values indicate improvement.
Baseline, Months 12, 36, 60, 84, and 102
Change From Baseline in Hematocrit up to Month 102
Time Frame: Baseline, Months 12, 36, 60, 84, and 102
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Increased hematocrit values indicate improvement.
Baseline, Months 12, 36, 60, 84, and 102
Change From Baseline in Reticulocyte Count up to Month 102
Time Frame: Baseline, Months 12, 36, 60, 84, and 102
Change (absolute change) from baseline will be calculated as post-baseline value - baseline value. Decreased reticulocyte count values indicate improvement.
Baseline, Months 12, 36, 60, 84, and 102
Change From Baseline in Haptoglobin up to Month 102
Time Frame: Baseline, Months 12, 36, 60, 84, and 102
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Increased haptoglobin values indicate improvement.
Baseline, Months 12, 36, 60, 84, and 102
Change From Baseline in Carboxyhemoglobin (COHb) at Week 24
Time Frame: Baseline and Week 24
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased COHb values indicate improvement.
Baseline and Week 24
Change From Baseline in COHb up to Month 30
Time Frame: Baseline, Months 12, 18, 24, and 30
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased COHb values indicate improvement.
Baseline, Months 12, 18, 24, and 30
Change From Baseline in LDH up to Month 30
Time Frame: Baseline, Months 12, 18, 24, and 30
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased LDH values indicate improvement.
Baseline, Months 12, 18, 24, and 30
Change From Baseline in Total Bilirubin up to Month 102
Time Frame: Baseline, Months 12, 36, 60, 84, and 102
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased total bilirubin values indicate improvement.
Baseline, Months 12, 36, 60, 84, and 102
Change From Baseline in Indirect Bilirubin up to Month 102
Time Frame: Baseline, Months 12, 36, 60, 84, and 102
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased indirect bilirubin values indicate improvement.
Baseline, Months 12, 36, 60, 84, and 102
Change From Baseline in (EPO) up to Month 30
Time Frame: Baseline, Months 12, 18, 24, and 30
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased EPO values indicate improvement.
Baseline, Months 12, 18, 24, and 30
Change From Baseline in Hepcidin up to Month 30
Time Frame: Baseline, Months 12, 18, 24, and 30
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased hepcidin values indicate improvement.
Baseline, Months 12, 18, 24, and 30
Change From Baseline in Ferritin up to Month 102
Time Frame: Baseline, Months 12, 36, 60, 84, and 102
Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased ferritin values indicate improvement.
Baseline, Months 12, 36, 60, 84, and 102
Change From Baseline in Transferrin Saturation up to Month 102
Time Frame: Baseline, Months 12, 36, 60, 84, and 102
Transferrin saturation is the ratio of serum iron to iron-binding capacity. Change (absolute change) from baseline was calculated as post-baseline value - baseline value. Decreased transferrin saturation values indicate improvement.
Baseline, Months 12, 36, 60, 84, and 102
Area Under the Concentration-time Curve From Time Zero to the Last Non-zero Concentration (AUC0-t) for AG-348 and Its Metabolite AGI-8702
Time Frame: pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose Day 1 and pre-dose, 0.5, 1, 2, 4, 8 hours post-dose Day 15
Participants with pre-dose concentrations on Day 1 were excluded from the pharmacokinetics analysis, if any.
pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose Day 1 and pre-dose, 0.5, 1, 2, 4, 8 hours post-dose Day 15
Maximum Plasma Concentration (Cmax) for AG-348 and Its Metabolite AGI-8702
Time Frame: pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose Day 1 and pre-dose, 0.5, 1, 2, 4, 8 hours post-dose Day 15
Participants with pre-dose concentrations on Day 1 were excluded from the pharmacokinetics analysis, if any.
pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose Day 1 and pre-dose, 0.5, 1, 2, 4, 8 hours post-dose Day 15
Time to Reach Peak Plasma Concentration (Tmax) for AG-348 and Its Metabolite AGI-8702
Time Frame: pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose Day 1 and pre-dose, 0.5, 1, 2, 4, 8 hours post-dose Day 15
Participants with pre-dose concentrations on Day 1 were excluded from the pharmacokinetics analysis, if any.
pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose Day 1 and pre-dose, 0.5, 1, 2, 4, 8 hours post-dose Day 15
Apparent Clearance at Steady-State (Clss/F) for AG-348 and Its Metabolite AGI-8702
Time Frame: pre-dose, 0.5, 1, 2, 4, 8 hours post-dose Day 15
Participants with pre-dose concentrations on Day 1 were excluded from the pharmacokinetics analysis, if any.
pre-dose, 0.5, 1, 2, 4, 8 hours post-dose Day 15
Maximum Change From Baseline Response Value Over 12 Hours Post-dose (BRmax) for Adenosine Triphosphate (ATP)
Time Frame: pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose Day 1
Pre-dose concentration observed on Day 1 was used as Baseline for calculation of change from baseline.
pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose Day 1
Maximum Change From Baseline Response Value Over 8 Hours Post-dose at Steady State (BRmax ss) for ATP
Time Frame: pre-dose, 0.5, 1, 2, 4, 8 hours post-dose Day 15
Pre-dose concentration observed on Day 1 was used as Baseline for calculation of change from baseline.
pre-dose, 0.5, 1, 2, 4, 8 hours post-dose Day 15
BRmax for 2,3 - Diphosphoglycerate (2,3-DPG)
Time Frame: pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose Day 1
Pre-dose concentration observed on Day 1 was used as Baseline for calculation of change from baseline.
pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose Day 1
BRmax ss for 2,3-DPG
Time Frame: pre-dose, 0.5, 1, 2, 4, 8 hours post-dose Day 15
Pre-dose concentration observed on Day 1 was used as Baseline for calculation of change from baseline.
pre-dose, 0.5, 1, 2, 4, 8 hours post-dose Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Agios Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AG348-C-003
  • 2015-000484-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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