Glecaprevir/Pibrentasvir (GLE/PIB) for Acute Hepatitis C

Verified Trial

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

In the last 11 months have you been newly diagnosed with Hepatitis C?

Must not have

Have you been diagnosed with Hepatitis B?

Have you participated in another clinical trial in the last 30 days?

Timeline

Screening 1 day

Treatment 8 weeks

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will help researchers understand if GLE/PIB is safe and effective for the treatment of acute HCV infection in adults and adolescents.

Who is the study for?

Adults and adolescents with recent Hepatitis C infection can join this trial. They must not have liver cancer, severe liver scarring, or previous treatments for HCV. Participants need a confirmed acute HCV diagnosis through specific tests and should show signs of recent infection or risk behavior.

What is being tested?

The study is testing the safety and effectiveness of GLE/PIB, an approved drug for chronic HCV, in treating acute HCV infections. Patients will take oral tablets daily for 8 weeks and be monitored for another 12 weeks after treatment ends.

What are the potential side effects?

Possible side effects include headaches, fatigue, nausea, difficulty sleeping, itching skin rashes or reactions at the tablet's intake site. More serious but less common side effects might affect the liver.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with liver disease.

Select...

I have been diagnosed with compensated cirrhosis.

Timeline

Screening ~ 1 day0 visits

Treatment ~ 8 weeks8 visits

Follow Up ~ 12 weeks1 visit

Screening ~ 1 day

Treatment ~ 8 weeks

Follow Up ~12 weeks

This trial's timeline: 1 day for screening, 8 weeks for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With Sustained Virological Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population

Secondary study objectives

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) in the Modified ITT-Virologic Failure (mITT-VF) Population.

Percentage of Participants With On-Treatment Virologic Failure in the ITT Population

Percentage of Participants With Post-Treatment Reinfection With HCV in the ITT Population

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