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Trial record 21 of 437 for:    Expanded Access Studies

Expanded Access to Glecaprevir/ Pibrentasvir

Expanded access is currently available for this treatment.
Verified April 2017 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT03123965
First received: April 18, 2017
Last updated: NA
Last verified: April 2017
History: No changes posted
  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

Ages Eligible for Study:   Child, Adult, Senior
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 18, 2017
Last Updated: April 18, 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

ClinicalTrials.gov processed this record on July 26, 2017