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NCT01197378 · ClinicalTrials.gov registry record · Phase 3

Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)

A Phase 3 study of Cystinosis, sponsored by Amgen.

Completed
Registry status
Phase 3
Development phase
60
Enrollment target
10
Study locations

NCT01197378 is a Phase 3 study of Cystinosis that has completed, run by Amgen. The registered enrollment target is 60 participants, below the 190-participant average among 4 other Cystinosis trials with a reported enrollment target (68% lower). The trial reports 10 study locations across 5 states.

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The verdict

NCT01197378, a Phase 3 study of Cystinosis, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 3
Development phase
60 participants
Enrollment target
10
Study locations

Study Summary

Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate immediate release) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. Cysteamine bitartrate delayed-release capsules (RP103) is a formulation of cysteamine bitartrate that is being studied to see if it can be given less frequently, once every 12 hours, and have similar results to four times a day Cystagon®.

Conditions Studied

Cystinosis

Interventions

  • DRUG Cysteamine Bitartrate Delayed-release Capsules

Study Locations (10)

Other

  • Hospices Civils de Lyon - Lyon
  • Hôpital Arnaud Villeneuve - CHU Montpellier - Montpellier
  • Hopital Necker - Paris
  • Robert Debre Hospital - Paris
  • Radboud University Nijmegen Medical Center - Nijmegen

California

  • California Pacific Medical Center (CPMC) Research Institute - San Francisco
  • Stanford University Medical School - Stanford

Georgia

  • Emory Children's Center - Atlanta

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago

Texas

  • Texas Children's Hospital/Baylor University - Houston

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2010-08-27
Est. Completion 2017-06-26
Phase Phase 3

Sponsor

Amgen

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01197378

The ClinicalTrials.gov registry entry for NCT01197378 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 190-participant average among 4 other Cystinosis trials with a reported enrollment target (68% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystinosis appearing as the primary indexed condition, and to 1 intervention - of which Cysteamine Bitartrate Delayed-release Capsules is the first listed.

NCT01197378 reports 10 study locations spanning 5 distinct geographic areas - top geographies include Other, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT01197378 about?

NCT01197378 is a clinical study titled "Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)". Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate immediate release) which must be taken every six hours for the rest of the patient's life to prevent complications of...

What is the current status of trial NCT01197378?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2010-08-27. Estimated completion is 2017-06-26.

What conditions does trial NCT01197378 study?

This clinical trial studies the following conditions: Cystinosis.

What interventions are being tested in trial NCT01197378?

The interventions under investigation include: Cysteamine Bitartrate Delayed-release Capsules (DRUG).

Who is sponsoring clinical trial NCT01197378?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01197378 being conducted?

This trial has 10 study locations across California, Georgia, Illinois, Texas. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.