Early Access Program for ALXN1840 in Patients With Wilson Disease

May 15, 2023 updated by: Alexion
This is an open-label, single-arm, multi-center EAP, designed to provide early access to ALXN1840 for eligible patients with WD.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

To provide access to ALXN1840 treatment, an investigational medicinal product (IMP) that has not yet been granted marketing authorization, to participants who complete Studies ALXN1840-WD-205, WTX101-301, or ALXN1840-WD-302, or other studies with ALXN1840 who, in the opinion of the Treating Physician, may benefit from continued treatment with ALXN1840, and who meet the eligibility criteria described in this protocol.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  1. ≥ 3 years of age or older at the time of providing informed consent/assent and expressed desire to continue treatment with ALXN1840.
  2. Confirmed diagnosis of WD.

  3. Has completed one of the following ALXN1840 clinical studies:

    1. ALXN1840-WD-205
    2. WTX101-301
    3. ALXN1840-WD-302
    4. Other ALXN1840 studies
  4. In the Treating Physician's medical opinion, the potential benefits of treatment with ALXN1840 outweigh the potential risks for the participant.
  5. Participant or legal representative provided informed consent/assent to be treated with ALXN1840 through this EAP.
  6. Female participants of childbearing potential and male participants must follow protocol-specified-contraception guidance.

Exclusion Criteria:

  1. Eligible for and able to participate in an Alexion-sponsored study of ALXN1840.
  2. Unwilling or unable to comply with the Treating Physician's treatment plan related to this EAP for any reason.
  3. Has decompensated hepatic cirrhosis.
  4. Model for End-Stage Liver Disease (MELD) score > 13.
  5. Modified Nazer Score > 7.
  6. End-stage renal disease on dialysis (chronic kidney disease stage 5 [CKD 5]) or creatinine clearance < 30 mL/min.
  7. Known hypersensitivity to ALXN1840, ALXN1840 excipients, or any of the ingredients contained in ALXN1840.
  8. Women who are nursing or pregnant (or women who are planning to become pregnant during treatment with ALXN1840).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9430R00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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