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NCT03123965 Clinical Trial

Expanded Access to Glecaprevir/ Pibrentasvir

Hepatitis C Virus Infection Clinical Trial

Official title:
Expanded Access to Glecaprevir/ Pibrentasvir

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT03123965
Other study ID # C16-563
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date January 2020
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• glecaprevir
Glecaprevir will be administered orally.
• pibrentasvir
Pibrentasvir will be administered orally.

Locations
Country Name City State
Slovenia Univ Medical Ctr Ljubljana /ID# 161419 Ljubljana

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Slovenia, 

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