Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)
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|ClinicalTrials.gov Identifier: NCT04042740|
Recruitment Status : Not yet recruiting
First Posted : August 2, 2019
Last Update Posted : August 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Infection HIV Infection||Drug: Glecaprevir/Pibrentasvir (G/P) Drug: Ribavirin (RBV)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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 ]
- 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
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
|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|