Study of ORL-1G (D-galactose) in Patients With Glycogen Storage Disease Type 14

NCT ID: NCT03404856

Last Updated: 2019-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-31

Study Completion Date

2019-10-31

Brief Summary

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Study of ORL-1G in Patients With Glycogen Storage Disease Type 14

Detailed Description

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Conditions

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Glycogen Storage Disease, Type 14

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with ORL-1G - D-galactose

Group Type OTHER

ORL-1G - D-galactose

Intervention Type DRUG

Oral ORL-1G - D-galactose

Interventions

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ORL-1G - D-galactose

Oral ORL-1G - D-galactose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Glycogen Storage Disease Type 14.
* Less than 18 years old.

Exclusion Criteria

* Diagnosis of any other disease that is not a manifestation of Glycogen Storage Disease Type 14.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orpha Labs

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Orpha Labs

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Study Coordinator Study Coordinator

Role: CONTACT

+90 537 763 6241

Facility Contacts

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Study Coordinator Study Coordinator

Role: primary

+905377636241

Other Identifiers

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GALA-1

Identifier Type: -

Identifier Source: org_study_id

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