We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Expanded Access to Glecaprevir/ Pibrentasvir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03123965
Expanded Access Status : Approved for marketing
First Posted : April 21, 2017
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information
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
Hepatitis C Virus Infection Drug: glecaprevir Drug: pibrentasvir

Study Design
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to Glecaprevir/ Pibrentasvir

Resource links provided by the National Library of Medicine


Interventions
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: glecaprevir
    Glecaprevir will be administered orally.
    Other Name: ABT-493
  • Drug: pibrentasvir
    Pibrentasvir will be administered orally.
    Other Name: ABT-530
Eligibility Criteria
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Contacts and Locations
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123965


Locations
Layout table for location information
Slovenia
Univ Medical Ctr Ljubljana /ID# 161419
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie
More Information
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03123965    
Other Study ID Numbers: C16-563
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 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:
Layout table for MeSH terms
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
 Infections
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections