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Expanded Access to Glecaprevir/ Pibrentasvir

Expanded access is currently available for this treatment.
Verified April 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT03123965
First Posted: April 21, 2017
Last Update Posted: April 21, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
  Purpose
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 Intervention
Hepatitis C Virus Infection Drug: glecaprevir Drug: pibrentasvir

Study Type: Expanded Access     What is Expanded Access?
Available for Individual Patients
Official Title: Expanded Access to Glecaprevir/ Pibrentasvir

Further study details as provided by AbbVie:

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

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.


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


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

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

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03123965     History of Changes
Other Study ID Numbers: C16-563
First Submitted: April 18, 2017
First Posted: April 21, 2017
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
Hepatitis
Liver Diseases
Digestive System Diseases