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Expanded Access to Glecaprevir/ Pibrentasvir

Sponsor
AbbVie (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT03123965
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to glecaprevir/ pibrentasvir prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access to Glecaprevir/ Pibrentasvir

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Univ Medical Ctr Ljubljana /ID# 161419 Ljubljana Slovenia 1000

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: AbbVie Inc., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03123965
    Other Study ID Numbers:
    • C16-563
    First Posted:
    Apr 21, 2017
    Last Update Posted:
    Jan 18, 2020
    Last Verified:
    Jan 1, 2020
    Keywords provided by AbbVie
    Special Access Scheme
    Expanded Access
    Pre-approval Access
    Compassionate Use
    Special Access Program
    Named Patient Basis
    Additional relevant MeSH terms:
    Hepatitis C

    Study Results

    No Results Posted as of Jan 18, 2020