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Expanded Access to Glecaprevir/ Pibrentasvir

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ClinicalTrials.gov Identifier: NCT03123965
Recruitment Status : Available
First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Information provided by (Responsible Party):

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
Hepatitis C Virus Infection Drug: glecaprevir Drug: pibrentasvir

Study Design

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

Intervention Details:
    Drug: glecaprevir
    It will be administered orally.
    Other Name: ABT-493
    Drug: pibrentasvir
    It will be administered orally.
    Other Name: ABT-530
Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Contacts and Locations

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

Contact: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com

Sponsors and Collaborators
Study Director: AbbVie Inc. AbbVie
More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03123965     History of Changes
Other Study ID Numbers: C16-563
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017

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
Virus Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases