Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04042740
Recruitment Status : Not yet recruiting
First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C Infection HIV Infection Drug: Glecaprevir/Pibrentasvir (G/P) Drug: Ribavirin (RBV) Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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 :
  1. Proportion of participants with HCV RNA less than LLOQ (TD or TND) [ Time Frame: Weeks 1, 2, 4, 8, 12, 28 ]
  2. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Acute HCV infection (or reinfection) within 24 weeks prior to entry (see protocol for definitions).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042740


Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
AbbVie
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04042740     History of Changes
Other Study ID Numbers: ACTG A5380
38553 ( Registry Identifier: DAIDS-ES Registry Number )
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie results in the publication, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.
Access Criteria:
  • With whom?

    • Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.
  • For what types of analyses?

    • To achieve aims in the proposal approved by the AIDS Clinical Trials Group.
  • By what mechanism will data be made available?

    • Researchers may submit a request for access to data using the AIDS Clinical Trials Group "Data Request" form at: https://actgnetwork.org/about-actg/templates-and-forms. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acute Hepatitis C Infection
Glecaprevir
Pibrentasvir
4 weeks
Direct-acting antivirals
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Virus Diseases
Liver Diseases
Digestive System Diseases
Infection
Hepatitis A
Hepatitis C
Hepatitis
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents