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NCT04995315 · ClinicalTrials.gov registry record

Pyruvate Kinase Deficiency Global Longitudinal Registry Substudy of Protocol AG348-C-008

A clinical trial, sponsored by Agios Pharmaceuticals.

Completed
Registry status
13
Enrollment target

NCT04995315: Completed study, sponsored by Agios Pharmaceuticals.

NCT04995315 is a clinical trial that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 13 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04995315 has completed, sponsored by Agios Pharmaceuticals.

COMPLETED
Registry status
13 participants
Enrollment target

Study Summary

This is a substudy of Study AG348-C-008, an observational, longitudinal, multicenter, global registry that aims to better understand the longitudinal clinical implications of pyruvate kinase deficiency (PK deficiency). The primary purpose of this study is to describe the cognition of participants with PK deficiency, as objectively measured by the Cogstate Brief Battery (CBB).

Primary Outcome

CBB is a series of brief computerized assessments used to evaluate 4 major cognitive domains: psychomotor speed, attention/vigilance, visual learning, and working memory. If the CBB score falls between -10 to +10, it is considered normal. In Cogstate scoring 0 could be considered as performing in the average range, a negative score means below-average performance, and a positive score means above-average performance. A positive change in scores indicates slightly better performance.

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2021-07-02
Est. Completion 2023-09-22
Agios Pharmaceuticals

44 total trials

What the finished NCT04995315 record still lists

NCT04995315 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 13 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT04995315 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04995315 about?

NCT04995315 is a clinical study titled "Pyruvate Kinase Deficiency Global Longitudinal Registry Substudy of Protocol AG348-C-008". This is a substudy of Study AG348-C-008, an observational, longitudinal, multicenter, global registry that aims to better understand the longitudinal clinical implications of pyruvate kinase deficiency (PK deficiency). The primary purpose of this study is to describe the cognition of participants wi...

What is the current status of trial NCT04995315?

This trial is currently completed. The enrollment target is 13 participants. The study started on 2021-07-02. Estimated completion is 2023-09-22.

Who is sponsoring clinical trial NCT04995315?

This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04995315, the US trial registry maintained by the National Library of Medicine. NCT04995315 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.