Authorised Phase I and Phase II (Integrated)- First administration to humans Ornithine Transcarbamylase Deficiency (OTC)

Long-term Follow-up (LTFU) Study of Participants in any iECURE Protocol Using an Investigational Product (IP)

EU CTIS ID: 2024-514190-21-00

What this study is testing

To assess the long-term safety of investigational product (IP) in participants who received IP and the long-term safety of those who never received IP regardless of causality

  • Phase I and Phase II (Integrated)- First administration to humans

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Enrolled in an iECURE parent protocol and have either completed or discontinued that protocol
  • Participant parent(s)/legal authorized representative (LAR) is willing and able to adhere to the protocol requirements.
  • Consent was obtained by the participants parent(s)/LAR (and participant assent, where applicable), prior to any study-related data being collected.

You likely can't join if

  • None

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom
  • United States
  • Australia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; United States; Australia. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.