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Allosteric Activator

Continued Access to Mitapivat for Pyruvate Kinase Deficiency

Phase 4

Waitlist Available

Research Sponsored by Agios Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 6.2 years

Awards & highlights

Study Summary

This trial will provide access to the med. mitapivat for those who completed a study & don't have it commercially.

Who is the study for?

This trial is for individuals who have completed a previous Agios-sponsored study on mitapivat and benefited from it, but can't get the drug commercially due to regulations or access issues. They must agree to use two forms of contraception if applicable, not join other studies, and comply with all procedures.Check my eligibility

What is being tested?

The trial provides continued access to mitapivat for participants with hemolytic anemia or pyruvate kinase deficiency who previously responded well in an earlier study but lack commercial access to the medication.See study design

What are the potential side effects?

While specific side effects are not listed here, participants should be aware that they may experience similar side effects as those encountered during their previous mitapivat trials. Known allergies or contraindications related to mitapivat's ingredients should be considered.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 6.2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 6.2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6.2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With AEs Considered by the Investigator to be Related to Study Drug

Percentage of Participants With AEs and SAEs, Graded by Severity

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

+1 more

Side effects data

From 2020 Phase 3 trial • 80 Patients • NCT03548220

50%

Gastroenteritis

100%

80%

60%

40%

20%

Study treatment Arm

Experimental: AG-348, 5 mg

Experimental: AG-348, 20 mg

Experimental: AG-348, 50 mg

Placebo Comparator: Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: MitapivatExperimental Treatment1 Intervention

Participants will receive mitapivat of 5, 20 or 50 milligrams (mg), orally, twice daily (BID), based on the last dose received by the participants in the antecedent study. Mitapivat will be administered from Day 1 up to end of treatment period of this study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mitapivat

2023

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Agios Pharmaceuticals, Inc.Lead Sponsor

52 Previous Clinical Trials

4,200 Total Patients Enrolled

Media Library

Mitapivat (Allosteric Activator) Clinical Trial Eligibility Overview. Trial Name: NCT05777993 — Phase 4

Hemolytic Anemia Research Study Groups: Mitapivat

Hemolytic Anemia Clinical Trial 2023: Mitapivat Highlights & Side Effects. Trial Name: NCT05777993 — Phase 4

Mitapivat (Allosteric Activator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05777993 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Mitapivat been green-lit by the Federal Drug Administration?

"Mitapivat's safety has been certified in a Phase 4 trial, thereby giving it an overall score of 3."

Answered by AI

Are there still openings for this clinical trial?

"Clinicaltrials.gov illustrates that this trial is not actively recruiting patients at the moment, as it was initially posted on June 1st 2023 and most recently edited on March 9th 2023. However, there are 27 other trials still enrolling participants currently."

Answered by AI

How many centers are offering this research initiative?

"This study is currently taking place in 8 different sites, with Kyoto Katsura Hospital, Toho University - Omori Medical Center, and Tochoku University Hospital being some of the more prominent ones."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Provide Continued Access to Mitapivat for Participants Who Previously Completed an Agios-Sponsored Mitapivat Study

2023. "A Study to Provide Continued Access to Mitapivat for Participants Who Previously Completed an Agios-Sponsored Mitapivat Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05777993.