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Protease Inhibitor

Ribavirin (RBV) for Hepatitis C (PURGE-C Trial)

Phase 2
Waitlist Available
Research Sponsored by AIDS Clinical Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1, 2, 4, 8, 12, 28
Awards & highlights

PURGE-C Trial Summary

This trial will test a 4-week course of a new medication for hepatitis C, with or without HIV-1 coinfection, to see if it is effective.

Eligible Conditions
  • Hepatitis C
  • HIV/AIDS

PURGE-C Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 2, 4, 8, 12, 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, 4, 8, 12, 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Proportion of participants who experienced adverse events (AEs)
Proportion of participants with sustained virologic response at 12 weeks post-treatment (SVR12)
Secondary outcome measures
Number of participants with HCV virologic failure
Proportion of participants with HCV RNA less than LLOQ

PURGE-C Trial Design

1Treatment groups
Experimental Treatment
Group I: Glecaprevir/Pibrentasvir (G/P)Experimental Treatment2 Interventions
In Step 1, participants will receive G/P FDC tablets to be taken orally once daily for 4 weeks. Any participant who experiences viral re-infection, suspected relapse, virologic failure, or undefined post-treatment HCV viremia may enter Step 2. In Step 2, participants may receive G/P FDC tablets orally once daily for 8-16 weeks. Some participants may also receive ribavirin (RBV) tablets orally twice daily. Alternate regimens are allowed in Step 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribavirin (RBV)
2008
Completed Phase 3
~7630
Glecaprevir/Pibrentasvir (G/P)
2019
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

AIDS Clinical Trials GroupLead Sponsor
100 Previous Clinical Trials
73,642 Total Patients Enrolled
4 Trials studying Hepatitis C
455 Patients Enrolled for Hepatitis C
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,268 Previous Clinical Trials
5,481,087 Total Patients Enrolled
52 Trials studying Hepatitis C
9,290 Patients Enrolled for Hepatitis C
AbbVieIndustry Sponsor
955 Previous Clinical Trials
501,185 Total Patients Enrolled
110 Trials studying Hepatitis C
32,784 Patients Enrolled for Hepatitis C

Frequently Asked Questions

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

Can more people still join this research project?

"That is correct, the trial information on clinicaltrials.gov reflects that this study is looking for 50 patients at 14 different sites. The postings dates you mentioned are accurate as well."

Answered by AI

How many people fit the screening criteria for this trial?

"The pharmaceutical company sponsoring this trial, AbbVie, needs 50 patients that fit the bill in order to move forward. The study will take place in University of Colorado Hospital CRS (6101) located in Aurora as well as Weill Cornell Chelsea CRS (7804) situated in New york City."

Answered by AI

Could you tell me if there is any prior research on Ribavirin (RBV)?

"Since 2010, when Memorial Sloan Kettering Cancer Center first studied ribavirin (RBV), there have been 622 completed clinical trials. Currently, 21 more are underway; many in Aurora, Colorado."

Answered by AI

How is Ribavirin (RBV) most often employed?

"RBV is usually given to patients that have already received treatment with ns3/4a protease inhibitor. However, it has also been known to help treat hiv positive patients and those with compensated liver disease that have undergone previous treatment with ns5a inhibitor."

Answered by AI

What is the government organization's opinion of RBV?

"Even though there is no data yet supporting its efficacy, our team has determined that Ribavirin (RBV) rates a 2 in terms of safety because Phase 2 trials have generated some evidence of safety."

Answered by AI

In how many different settings is this trial being conducted?

"There are many enrolling hospitals for this clinical trial, including University of Colorado Hospital CRS (6101) in Aurora, Colorado, Weill Cornell Chelsea CRS (7804) in New york, New York, and The Miriam Hosp. ACTG CRS (2951) in Providence, Rhode island just to list a few of the 14 other locations."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Texas
Georgia
How old are they?
18 - 65
What site did they apply to?
Ucsd, Avrc Crs (701)
Other
Trinity Health and Wellness Center CRS
The Ponce de Leon Center CRS (5802)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I need to treat my hep c of never been treated before and I can't afford treatment even with my insurance.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Ucsd, Avrc Crs (701): < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection
2019. "Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04042740.
~8 spots leftby Apr 2025
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