Clinical Trials

MainTitle

Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)

This study is ongoing, but not recruiting participants.
Sponsor
AIDS Clinical Trials Group

Collaborator
AbbVie
National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party)
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier
NCT04042740

First received: July 31, 2019
Last updated: April 8, 2020
Last Verified: April 2020
History of Changes
Purpose

Purpose

The purpose of this study is to assess the efficacy of a fixed dose combination (FDC) of glecaprevir/pibrentasvir (G/P) given for 4 weeks in acute hepatitis C (HCV)-infected participants, with or without HIV-1 coinfection.

Condition Intervention Phase
Hepatitis C Infection
HIV Infection

Drug : Glecaprevir/Pibrentasvir (G/P)
Drug : Ribavirin (RBV)
Phase 2

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)

Further study details as provided by AIDS Clinical Trials Group:

Primary Outcome Measures

  • Proportion of participants with sustained virologic response at 12 weeks post-treatment (SVR12) [ Time Frame: Week 16 (12 weeks post treatment) ]
    SVR12 defined as achieving unquantifiable HCV RNA (less than the lower limit of quantification [LLOQ] target detected [TD] or target not detected [TND]) at study visit 12 weeks post treatment. If a participant does not have any HCV RNA measurements in this time period then the participant will be considered as SVR12 failure, unless there are preceding and subsequent HCV RNA measurements that are both LLOQ (either TD or TND).
  • Proportion of participants who experienced adverse events (AEs) [ Time Frame: From study treatment initiation to 4 weeks after study treatment discontinuation (Week 8) ]
    Study protocol required reporting of (1) AEs Grade greater than or equal to 2, (2) AEs that led to a change in study treatment regardless of grade and (3) AEs meeting ICH definition of SAE or Expedited AE (EAE) reporting requirement. DAIDS AE Grading Table (V2.1) and DAIDS EAE Manual (V2.0) are used.
  • Number of participants who complete 4 weeks of treatment without discontinuation due to AEs [ Time Frame: From study entry to Week 4 ]
Secondary Outcome Measures:
  • Proportion of participants with HCV RNA less than LLOQ (TD or TND) [ Time Frame: Weeks 1, 2, 4, 8, 12, 28 ]
  • Number of participants with HCV virologic failure [ Time Frame: Weeks 1, 2, 4 ]
    Virologic failure defined as failure to achieve unquantifiable HCV RNA and confirmed increase in HCV RNA greater than 1 log10 from on-treatment nadir

Estimated Enrollment: 50
Study Start Date: November 15, 2019
Estimated Study Completion Date: March 2, 2023
Estimated Primary Completion Date: March 2, 2023 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Glecaprevir/Pibrentasvir (G/P)
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.
Drug: Glecaprevir/Pibrentasvir (G/P)

Fixed-dose combination (FDC) tablets containing 100 mg of glecaprevir and 40 mg of pibrentasvir; administered as 3 tablets orally.

Drug: Ribavirin (RBV)

Tablets containing 200 mg of ribavirin. RBV dosed according to weight-based and renal dosing tables in study protocol.

Detailed Description:

The study will be conducted in two steps. In Step 1, participants will receive four weeks of treatment with G/P for acute HCV infection and then followed 24 weeks post treatment. Participants with HCV recurrence (reinfection, suspected relapse or undefined post-treatment viremia) or HCV virologic failure before or at the Step 1 Week 16/SVR12 (sustained virologic response 12 weeks post-treatment) visit may enter Step 2 for re-treatment. The remaining participants complete the study at Week 28 of Step 1. The study primary and secondary outcome measures pertain to Step 1.
In Step 2, participants will be re-treated with G/P with or without ribavirin (RBV) for up to 16 weeks, and followed for 24 weeks post treatment. Post-treatment follow-up for Step 2 will include visits for SVR12 determination after re-treatment.
In Step 1, study visits are scheduled at study entry, weeks 1 and 2 (on-treatment), week 4 (treatment discontinuation), and weeks 8, 12, 16 and 28 (post-treatment follow-up). In Step 2, participants will have study visits during the re-treatment period, where the number of visits depends on the re-treatment, and visits at 12 and 24 weeks post treatment. Study visits may include physical examinations, clinical assessments, blood and urine collection, questionnaires, and HCV re-infection prevention counseling.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria

  • Acute HCV infection (or reinfection) within 24 weeks prior to entry.
  • Detectable HCV RNA at the screening visit.

  • Exclusion Criteria
  • Any HCV treatment during the current acute HCV infection episode.
  • Known preexisting cirrhosis
  • Acute HIV-1 infection
  • Presence of active or acute AIDS-defining opportunistic infections, active serious infection (other than HIV-1 or HCV), active hepatitis B virus (HBV) or active hepatitis A virus (HAV)
  • Chronic use of systemically administered immunosuppressive agents
  • History of solid organ transplantation.
  • History of conditions that could interfere with the absorption of the study drug.
  • Concurrent use of prohibited medications
  • Known hypersensitivity to glecaprevir or pibrentasvir, the metabolites, or parts of the formulation.
  • Females who are pregnant or breastfeeding
  • Males with pregnant female partner.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04042740

Locations

United States, California
Ucsd, Avrc Crs (701)
San Diego, California, United States, 92103
United States, Massachusetts
Massachusetts General Hospital ACTG CRS (101)
Boston, Massachusetts, United States, 02114
United States, North Carolina
Unc Aids Crs (3201)
Chapel Hill, North Carolina, United States, 27514
United States, Rhode Island
The Miriam Hosp. ACTG CRS (2951)
Providence, Rhode Island, United States, 02906

Sponsors and Collaborators

AIDS Clinical Trials Group
AbbVie
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: Arthur Y. Kim, MD Massachusetts General Hospital (MGH) CRS
Study Chair: Susanna Naggie, MD, MHS Duke University Medical Center CRS
Study Chair: David Wyles, MD University of Colorado Hospital CRS
More Information

More Information


Responsible Party: AIDS Clinical Trials Group  
ClinicalTrials.gov Identifier: NCT04042740   History of Changes  
Other Study ID Numbers: ACTG A5380  
  38553  
Study First Received: July 31, 2019  
Last Updated: April 8, 2020  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  
Product Manufactured in and Exported from the U.S.: Yes  

Keywords provided by AIDS Clinical Trials Group:

Acute Hepatitis C Infection
Glecaprevir
Pibrentasvir
4 weeks
Direct-acting antivirals

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis
Virus Diseases
Ribavirin

ClinicalTrials.gov processed this data on August 13, 2020
This information is provided by ClinicalTrials.gov.