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A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents with Acute Hepatitis C Virus (HCV) Infection

Clinical Trial Details

This is a research study for men and women over the age of 18 who have Acute Hepatitis C Virus Infection. 

This research study will use a study drug called glecaprevir/pibrentasvir (G/P). It contains two drugs for treating hepatitis in one pill. G/P belongs to a group of drugs called direct-acting antiviral agents (DAAs) and prevents the disease from multiplying and spreading in the human body. 

G/P is approved by the U. S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis HCV without or with cirrhosis (scarring of the liver), but has not been approved to treat Acute Hepatitis C Infection.

Participants will take G/P for 8 weeks and total study participation will last approximately 12 weeks.   

Key Eligibility: 

   1. Men and women who are 18 years and older. Women of child-bearing potential must not be pregnant or breastfeeding.
   2. Have been diagnosed with Acute Hepatitis C infection.
   3. Enrolled in a drug treatment program.

Study contact by location

Upper East Side - Manhattan

Contact(s)

GI/ Hepatology
(646) 962-4040
GIHepResearch@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2202024374

ClinicalTrials.gov:

NCT04903626

Sponsor:

AbbVie M20-350

Status

Open to Enrollment

Age Group

Adult

Sponsor

Disease