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Expanded Access to Glecaprevir/ Pibrentasvir

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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

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

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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



Intervention Details:
  • Drug: glecaprevir
    Glecaprevir will be administered orally.
    Other Name: ABT-493
  • Drug: pibrentasvir
    Pibrentasvir will be administered orally.
    Other Name: ABT-530

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No

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
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Slovenia
Univ Medical Ctr Ljubljana /ID# 161419
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
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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:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections