Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects

Conditions

• HCV
• Hepatitis C

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Glecaprevir/Pibrentasvir (G/P) 300mg/120mg — DRUG
  daily
• Ribavirin 200Mg Tablet — DRUG
  Weight-based 1000-1200 mg

Study Details

The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not complete the prescribed duration due to adverse event or any reason other than for non/poor compliance. Subjects will be randomized to 12 or 16 weeks of treatment.

Key Dates

Start date

Apr 20, 2017

Status verified

Feb 2020

Primary completion

Dec 28, 2018

Completion

Feb 6, 2020

Study Design

Enrollment

177 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: G/P 300 mg/120 mg QD for 12 Wks
  Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks.
• Experimental: Arm B: G/P 300 mg/120 mg QD for 16 Wks
  Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks)
• Experimental: Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks
  Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks)
• Experimental: Arm D: G/P 300 mg/120 mg QD for 16 Wks
  Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks)

Primary Outcome Measure

SVR After G/P 12 Wks (Arm A) vs. G/P Given for 16 Weeks (Arm B) to Non-cirrhotic Treatment-experienced GT1 HCV Participants [ Time Frame: Up to 28 weeks ]

Locations (31)

Find similar trials in Palo Alto, CA

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