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Protease Inhibitor

Glecaprevir/Pibrentasvir (G/P) for Hepatitis C (PURGE-C Trial)

Phase 2

Waitlist Available

Research Sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

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

No Placebo-Only Group

Summary

This trial tests a combination pill of two drugs for treating hepatitis C infections, including in people who also have HIV. The drugs work by stopping the virus from multiplying. The current recommendation for treating hepatitis C virus (HCV) in HIV patients includes the combination of sofosbuvir (SOF) and daclatasvir (DCV).

Eligible Conditions

Hepatitis C
HIV/AIDS

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1, 2, 4, 8, 12, 28

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

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

Primary study objectives

Number of Participants Who Completed 4 Weeks of Treatment Without Discontinuation Due to AEs

Percentage of Participants Who Experienced Adverse Events (AEs)

Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment Discontinuation (SVR12)

Secondary study objectives

Number of Participants With HCV Virologic Failure

Percentage of Participants With HCV RNA Less Than LLOQ

Other study objectives

Number of Participants by HCV Re-Treatment Regimen in Step 2

Side effects data

From 2023 Phase 2 trial • 45 Patients • NCT04042740

25%

Cellulitis

25%

Secondary syphilis

25%

Haematuria

25%

Proctitis gonococcal

25%

Insomnia

25%

Weight increased

25%

Genital pain

25%

Hyponatraemia

25%

Micturition urgency

25%

Rash

25%

Alanine aminotransferase increased

25%

Oropharyngeal gonococcal infection

25%

Back pain

25%

Dysuria

25%

Proteinuria

25%

Fatigue

25%

Constipation

25%

Proctalgia

25%

Proctitis herpes

25%

Skin laceration

100%

80%

60%

40%

20%

Study treatment Arm

HCV Re-Treatment Regimens

Glecaprevir/Pibrentasvir (G/P)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Glecaprevir/Pibrentasvir (G/P)Experimental Treatment1 Intervention

Participants were assigned to receive G/P FDC tablets to be taken orally once daily for 4 weeks (Step 1). Participants who experienced HCV re-infection, suspected relapse, virologic failure, or undefined post-treatment viremia in Step 1 were offered to enter Step 2 for re-treatment. HCV re-treatment regimens may have included G/P FDC tablets orally once daily for 8-16 weeks, or alternate regimens through clinical care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glecaprevir/Pibrentasvir (G/P)

2019

Completed Phase 2

~50

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