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Protease Inhibitor
Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (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
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 • NCT0404274020%
Alanine aminotransferase increased
18%
Creatinine renal clearance decreased
13%
Aspartate aminotransferase increased
11%
COVID-19
7%
Bilirubin conjugated increased
7%
Arthralgia
4%
Proctitis
4%
Lipase increased
4%
Monkeypox
4%
Blood bilirubin increased
4%
Abdominal pain
4%
Myalgia
4%
Blood glucose increased
4%
Skin laceration
2%
Mental status changes
2%
Urethritis chlamydial
2%
Hyperglycaemia
2%
Dysuria
2%
Oropharyngeal gonococcal infection
2%
Gonorrhoea
2%
Hordeolum
2%
Suicidal ideation
2%
Purulent discharge
2%
Otitis externa
2%
Overdose
2%
Wound infection staphylococcal
2%
Proctitis chlamydial
2%
Glycosuria
2%
Upper respiratory tract infection
2%
Influenza
2%
Osteoarthritis
2%
Abdominal abscess
2%
Urethritis gonococcal
2%
Proctalgia
2%
Orchitis
2%
Otitis media
2%
Haemoglobin decreased
2%
Ear pain
2%
Haemorrhoids
2%
Anal gonococcal infection
2%
Staphylococcal skin infection
2%
Hypoglycaemia
2%
Neck pain
2%
Anxiety
2%
Blood sodium decreased
2%
Pyrexia
2%
Inguinal mass
2%
Bipolar disorder
2%
Rash pustular
2%
Creatinine renal clearance
2%
Hypertransaminasaemia
2%
Insomnia
2%
Haematuria
2%
Cough
2%
Penile ulceration
2%
Proctitis gonococcal
2%
Activated partial thromboplastin time prolonged
2%
Conjunctival haemorrhage
2%
Dermatitis atopic
2%
Constipation
2%
Flatulence
2%
Carotid artery disease
2%
Diarrhoea
2%
Viral infection
2%
Gilbert's syndrome
2%
Blood creatinine increased
2%
Prothrombin time prolonged
2%
High risk sexual behaviour
2%
Wrist fracture
2%
Anal chlamydia infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Glecaprevir/Pibrentasvir (G/P)
HCV Re-Treatment Regimens
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
Find a Location
Who is running the clinical trial?
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsLead Sponsor
101 Previous Clinical Trials
74,010 Total Patients Enrolled
4 Trials studying Hepatitis C
455 Patients Enrolled for Hepatitis C
AIDS Clinical Trials GroupLead Sponsor
100 Previous Clinical Trials
73,503 Total Patients Enrolled
4 Trials studying Hepatitis C
455 Patients Enrolled for Hepatitis C
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,336 Previous Clinical Trials
5,392,719 Total Patients Enrolled
52 Trials studying Hepatitis C
9,290 Patients Enrolled for Hepatitis C
AbbVieIndustry Sponsor
1,040 Previous Clinical Trials
523,534 Total Patients Enrolled
110 Trials studying Hepatitis C
32,787 Patients Enrolled for Hepatitis C
Susanna Naggie, MD, MHSStudy ChairDuke University Medical Center CRS
Arthur Y. Kim, MDStudy ChairMassachusetts General Hospital (MGH) CRS
David Wyles, MDStudy ChairUniversity of Colorado Hospital CRS