- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05014724
CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)
January 23, 2024 updated by: UCB Biopharma SRL
This Post Trial Access (PTA) Program enables access to rozanolixizumab for eligible patients who have taken part in the CIDP04 trial (NCT04051944) and are continuing to derive benefit from treatment.
Study Overview
Status
No longer available
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: UCB Cares
- Phone Number: 0018445992273
- Email: ucbcares@ucb.com
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
- Patient who has taken part in the CIDP04 (NCT04051944) study
- Patient who derives continued benefit from treatment
- All required safety information has been reported as per local laws/regulations, reported to Bionical, as appropriate, and documented in the patient's medical records
- Patient is not pregnant
Exclusion Criteria:
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
Investigators
- Study Director: UCB Cares, 001 844 599 2273 (UCB)
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
August 19, 2021
First Submitted That Met QC Criteria
August 19, 2021
First Posted (Actual)
August 20, 2021
Study Record Updates
Last Update Posted (Actual)
January 25, 2024
Last Update Submitted That Met QC Criteria
January 23, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Disease Attributes
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Polyradiculoneuropathy
- Chronic Disease
- Polyneuropathies
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- Physiological Effects of Drugs
- Immunosuppressive Agents
- Immunologic Factors
- Rozanolixizumab
Other Study ID Numbers
- CIDP07
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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