Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients

Completed · Phase 3

Conditions studied: Hepatitis C, Chronic

In brief

The aim of this study is to determine if treatment monitoring schedule for chronic HCV patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified. Data has shown that direct acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor respectively , provides key features for HCV treatment simplification. Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to the standard or simplified monitoring arm and will receive treatment for 8 weeks. One post treatment visit will be conducted 12 weeks after the final dose of study medication to evaluate the proportion of patients with undetectable HCV RNA at this timepoint (SVR12).

Key facts

Study ID

NCT03117569

Run by

Kirby Institute

People needed

380

Starts

2017-08-21

Expected to finish

2018-12-19

Last updated by the study team

2019-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have voluntarily signed the informed consent form.
• 18 years of age or older.
• Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
• HCV RNA plasma ≥ 10,000 IU/ml at screening.
• HCV genotype 1-6.
• HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication).
• Stage F0-3, based on: hepatic elastography <12.5 kPa on Fibroscan® or APRI <1.0.
• If co-infection with HIV is documented, the subject must meet the following criteria:
• ART naïve with CD4 T cell count >500 cells/mm3; OR
• On a stable ART regimen (containing only permissible ART - see protocol section 3.2) for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and a plasma HIV RNA level below the limit of detection.
• Negative pregnancy test at screening and baseline (females of childbearing potential only).
• All fertile females must be using effective contraception during treatment and during the 30 days after treatment end.

You may not qualify if…

• History of any of the following:
• Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
• Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage).
• Solid organ transplant.
• History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
• Any of the following lab parameters at screening:
• ALT > 10 x ULN
• AST > 10 x ULN
• Direct bilirubin > ULN
• Platelets < 90,000/μL (cells/mm3) if Fibroscan® <12.5 kPa OR < 150,000/μL (cells/mm3) if Fibroscan® is unavailable and patient is included with APRI <1
• Creatinine clearance (CLcr) < 50 mL/min
• Haemoglobin < 12g/dL for males; <11g/dL for females
• Albumin < LLN
• INR > 1.5 ULN unless subject has known haemophilia or is stable on an anticoagulant regimen affecting INR
• Pregnant or breastfeeding female.
• HBV infection (HBsAg positive).
• Use of prohibited concomitant medications as described in protocol section 5.2.
• Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks).
• Therapy with any anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤6 months prior to the first dose of study drug.
• Any investigational drug ≤6 weeks prior to the first dose of study drug.
• Ongoing severe psychiatric disease as judged by the treating physician.
• Positive result of a urine drug screen at the Screening Visit for opiates, barbiturates, amphetamines, cocaine, benzodiazepines, phencyclidine, propoxyphene, or alcohol, with the exception of a positive result (including methadone) associated with documented short-term use or chronic stable use of a prescribed medication in that class.
• Injecting drug use within the previous six months.
• Inability or unwillingness to provide informed consent or abide by the requirements of the study.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• New York University Langone Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• SSM Health Dean Medical Group — Madison, Wisconsin, United States
• East Sydney Doctors — Sydney, New South Wales, Australia
• St Vincent's Hospital Sydney — Sydney, New South Wales, Australia
• Holdsworth House Medical Practice — Sydney, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• St Vincent's Hospital Melbourne — Melbourne, Victoria, Australia
• Lair Centre — Vancouver, British Columbia, Canada
• (G.I.R.I.) GI Research Institute — Vancouver, British Columbia, Canada
• William Osler Health System — Brampton, Ontario, Canada
• St Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• McGill University Health Centre (MUHC) — Montreal, Quebec, Canada
• CHU de Québec-Université Laval — Québec, Quebec, Canada
• Hopital Henri Mondor — Créteil, France
• Hopital Saint Joseph — Marseille, France
• Hopital Saint Antoine — Paris, France
• zibp - Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH — Berlin, Germany
• Center for HIV and Hepatogastroenterology — Düsseldorf, Germany
• Hannover Medical School — Hanover, Germany
• CIM-Centrum fuer Interdisziplinaere Medizin GmbH — Münster, Germany
• Auckland City Hospital — Auckland, New Zealand

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.