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NCT01208389 · ClinicalTrials.gov registry record · Phase 1

Phase 1 Follow-on Study of AAV2-hRPE65v2 Vector in Subjects With Leber Congenital Amaurosis (LCA) 2

A Phase 1 study of Leber Congenital Amaurosis, sponsored by Spark Therapeutics.

Active
Registry status
Phase 1
Development phase
12
Enrollment target
1
Study location

NCT01208389 is a Phase 1 study of Leber Congenital Amaurosis that is active but no longer recruiting, run by Spark Therapeutics. The registered enrollment target is 12 participants, below the 26-participant average among 6 other Leber Congenital Amaurosis trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01208389, a Phase 1 study of Leber Congenital Amaurosis, is active but no longer recruiting, sponsored by Spark Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
12 participants
Enrollment target
1
Study location

Study Summary

The study is a follow-on to a Phase 1 dose-escalation and safety study.

Conditions Studied

Interventions

  • BIOLOGICAL voretigene neparvovec-rzyl

Study Locations (1)

Pennsylvania

  • The Children's Hospital of Philadelphia - Philadelphia

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2010-11
Est. Completion 2027-10
Phase Phase 1

Sponsor

Spark Therapeutics

13 total trials

What the Registry Record Tells You About NCT01208389

The ClinicalTrials.gov registry entry for NCT01208389 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 26-participant average among 6 other Leber Congenital Amaurosis trials with a reported enrollment target (54% lower). The listed sponsor is Spark Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Leber Congenital Amaurosis appearing as the primary indexed condition, and to 1 intervention - of which voretigene neparvovec-rzyl is the first listed.

NCT01208389 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01208389 about?

NCT01208389 is a clinical study titled "Phase 1 Follow-on Study of AAV2-hRPE65v2 Vector in Subjects With Leber Congenital Amaurosis (LCA) 2". The study is a follow-on to a Phase 1 dose-escalation and safety study.

What is the current status of trial NCT01208389?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-11. Estimated completion is 2027-10.

What conditions does trial NCT01208389 study?

This clinical trial studies the following conditions: Leber Congenital Amaurosis.

What interventions are being tested in trial NCT01208389?

The interventions under investigation include: voretigene neparvovec-rzyl (BIOLOGICAL).

Who is sponsoring clinical trial NCT01208389?

This trial is sponsored by Spark Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01208389 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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