Back to resultsExpanded Access to Glecaprevir/ Pibrentasvir
Primary Purpose
Hepatitis C Virus Infection
Status
Approved for marketing
Phase
Locations
Slovenia
Study Type
Expanded Access
Intervention
glecaprevir
pibrentasvir
Sponsored by
About this trial
This is an expanded access trial for Hepatitis C Virus Infection focused on measuring Special Access Scheme, Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis
Eligibility Criteria
Sites / Locations
- Univ Medical Ctr Ljubljana /ID# 161419
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03123965
Brief Title
Expanded Access to Glecaprevir/ Pibrentasvir
Official Title
Expanded Access to Glecaprevir/ Pibrentasvir
Study Type
Expanded Access
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection
Keywords
Special Access Scheme, Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
glecaprevir
Other Intervention Name(s)
ABT-493
Intervention Description
Glecaprevir will be administered orally.
Intervention Type
Drug
Intervention Name(s)
pibrentasvir
Other Intervention Name(s)
ABT-530
Intervention Description
Pibrentasvir will be administered orally.
10. Eligibility
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Univ Medical Ctr Ljubljana /ID# 161419
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Learn more about this trial
Expanded Access to Glecaprevir/ Pibrentasvir
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