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Anti-viral

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 days
Treatment 8 weeks
Follow Up 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 days
Treatment ~ 8 weeks
Follow Up ~12 weeks
This trial's timeline: 1 days for screening, 8 weeks for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Sustained Virological Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population
Secondary outcome measures
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
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants Treated With Glecaprevir/Pibrentasvir for 8 weeksExperimental Treatment1 Intervention
Participants treated once daily with oral tablets of glecaprevir/pibrentasvir for 8 weeks.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,101 Total Patients Enrolled
110 Trials studying Hepatitis C
32,546 Patients Enrolled for Hepatitis C
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,815 Total Patients Enrolled
10 Trials studying Hepatitis C
7,881 Patients Enrolled for Hepatitis C
Site NameJohns Hopkins
JH IRB Protocol NumberIRB00293327
Principal InvestigatorJuhi Moon, MD

Media Library

Glecaprevir/Pibrentasvir (GLE/PIB) (Anti-viral) Clinical Trial Eligibility Overview. Trial Name: NCT04903626 — Phase 3
Hepatitis C Research Study Groups: Participants Treated With Glecaprevir/Pibrentasvir for 8 weeks
Hepatitis C Clinical Trial 2023: Glecaprevir/Pibrentasvir (GLE/PIB) Highlights & Side Effects. Trial Name: NCT04903626 — Phase 3
Glecaprevir/Pibrentasvir (GLE/PIB) (Anti-viral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04903626 — Phase 3
Hepatitis C Patient Testimony for trial: Trial Name: NCT04903626 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being given the chance to participate in this research project?

"A total of 283 patients who fit the bill are required for this study to move forward. If you're interested, sites in Worcester and Milwaukee are still looking for participants."

Answered by AI

Are we still enrolling patients in this research project?

"That is right, the clinical trial is currently underway and recruiting patients. The posting on clinicaltrials.gov was published on August 24th, 2021 and last updated October 31st, 2022. They are looking for a total of 283 patients from 50 different sites."

Answered by AI

What are the risks of taking Glecaprevir/Pibrentasvir (GLE/PIB)?

"GLE/PIB has undergone multiple rounds of testing, with some data supporting efficacy. Consequently, our team rates its safety as a 3."

Answered by AI

What diseases does Glecaprevir/Pibrentasvir (GLE/PIB) target?

"Glecaprevir/Pibrentasvir (GLE/PIB) has been used to treat patients that have previously received ns5a inhibitors. In addition, GLE/PIB is an effective treatment for other conditions such as hepatitis c, chronic hepatitis c genotype 5, and chronic hepatitis c genotype 2."

Answered by AI

Is this a new or unique study?

"Merck Sharp & Dohme LLC first studied Glecaprevir/Pibrentasvir (GLE/PIB) in 2016 with 75 participants. Following the initial study, Phase 1 & 2 drug approval was received in [year]. As of today, there are 13 active studies being conducted for GLE/PIB across 68 cities and 10 countries."

Answered by AI

At how many different hospitals is this trial being conducted?

"So far, 50 patients have signed up for this study at locations like UMass Memorial Medical Center /ID# 228442 in Worcester, Medical College of Wisconsin - Plank Rd /ID# 230116 in Milwaukee, and South Riverdale Community Health Centre /ID# 228098 in Toronto."

Answered by AI

What other research has been conducted on the effects of Glecaprevir/Pibrentasvir (GLE/PIB)?

"The original trial for glecaprevir/pibrentasvir (GLE/PIB) took place in 2016 at the Hospital of the University of Pennsylvania. As of right now, 37 studies have been completed and 13 are still actively recruiting patients. A majority of these open trials are based in Worcester, Massachusetts."

Answered by AI

Who else is applying?

What state do they live in?
California
Kentucky
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins University /ID# 230694
North Jersey Community Research Initiative (NJCRI) /ID# 245129
Atrium Health - Huntersville /ID# 238365
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
0

Why did patients apply to this trial?

Need money and have hep c! I've tried 2 prior treatment s hopefully this will take.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How soon can I get paid? How soon can this begin?
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Johns Hopkins University /ID# 230694: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)
2021. "Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04903626.
All > Autoimmune Hepatitis > Hepatitis C
~77 spots leftby Apr 2025
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