CClinicalTrials.gg
CompletedNCT03285126Updated Jul 2, 2019

Pompe Gene Therapy- Screening for Eligibility

An observational study in Pompe Disease (Late-onset), sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-02.

Sponsored by Duke University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
19
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine eligibility for the future clinical trial of gene therapy in adults with late-onset Pompe disease.

This screening protocol will enroll up to 20 adults patients (>=18 yo) with late-onset Pompe disease. Study assessments include review of medical history, vital signs, physical examination, muscle function testing, lung function testing, blood and urine collection, serum pregnancy test and ECG.

The study results will be collected to perform descriptive statistical analysis and used to determine eligibility for the proposed clinical trial of gene therapy in the future.

02

Conditions studied

  • Pompe Disease (Late-onset)
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults with late on-set Pompe Disease.

Inclusion criteria

  • Diagnosis of Pompe disease by blood or skin fibroblast GAA assay and two pathogenic variants in the GAA gene.
  • Age: at least 18 years at enrollment.
  • Subjects are capable of giving written consent.
  • Receiving ERT at a stable dose for at least 104 weeks.

Exclusion criteria

Exclusion Criteria

  • Any condition that would interfere with participation in the study as determined by the principal investigator.
  • Pregnancy or nursing mothers.
  • History of active hepatitis B, hepatitis C, or cirrhosis
  • Receiving any investigational agent.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
19 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Eligibility for gene therapy.

    The purpose of this study is to determine eligibility for the proposed clinical trial of gene therapy in adults with late-onset Pompe disease. Eligibility is measure by a composite score of blood tests, Electrocardiogram, Pulmonary Function Tests, and Muscle Status Testing.

    Time frame: Up to 2 days

06

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27701, United States
07

Registry details

Key details

Study ID
NCT03285126
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Nov 1, 2017
Primary completion
Jun 29, 2019
Completion
Jun 29, 2019
Last update
Jul 2, 2019

Study contacts

Dwight Koeberl
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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