EUCTR2017-000694-37-FRActive, not recruitingPhase 1
A phase IIIb, open-label, multicentre, international randomised controlled trial of simplified treatment monitoring for 8 weeks glecaprevir (300mg)/pibrentasvir (120mg) in chronic HCV treatment naïve patients without cirrhosis - SMART-C
niversity of New South Wales Sydney0 sites380 target enrollmentStarted: December 18, 2017Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 380
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1) Have voluntarily signed the informed consent form.
- •2) 18 years of age or older.
- •3) Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
- •4) HCV RNA plasma = 10,000 IU/ml at screening.
- •5) HCV genotype 1-6.
- •6) HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication).
- •7) Stage F0-3, based on: hepatic elastography <12.5 kPa on Fibroscan® or APRI <1.0.
- •8) If co-infection with HIV is documented, the subject must meet the following criteria:
- •- ART naïve with CD4 T cell count >500 cells/mm3;
- •- On a stable ART regimen 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.
- •9) Negative pregnancy test at screening and baseline (females of childbearing potential only).
- •10) All fertile females must be using effective contraception during treatment and during the 30 days after treatment end.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 360
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
Exclusion Criteria
- •1) History of any of the following:
- •a. 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.
- •b. Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage).
- •c. Solid organ transplant.
- •d. History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
- •2) Any of the following lab parameters at screening:
- •a. ALT > 10 x ULN
- •b. AST > 10 x ULN
- •c. Direct bilirubin > ULN
- •d. 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
- •e. Creatinine clearance (CLcr) < 50 mL/min
- •f. Haemoglobin < 12g/dL for males; <11g/dL for females
- •g. Albumin < LLN
- •h. INR > 1.5 ULN unless subject has known haemophilia or is stable on an anticoagulant regimen affecting INR
- •3) Pregnant or breastfeeding female.
- •4) HBV infection (HBsAg positive).
- •5) Use of prohibited concomitant medications.
- •6) Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks).
- •7) 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.
- •8) Any investigational drug =6 weeks prior to the first dose of study drug.
- •9) Ongoing severe psychiatric disease as judged by the treating physician.
- •10) 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.
- •11) Injecting drug use within the previous six months.
- •12) Inability or unwillingness to provide informed consent or abide by the requirements of the study.
Investigators
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