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Protocol NumberM16-135

2017-04-01 - 2018-12-31

Phase III

Terminated3

ICD-10B18.2

Chronic viral hepatitis C

ICD-10B18

Chronic viral hepatitis

ICD-9070.54

Chronic hepatitis C without mention of hepatic coma

A Single Arm, Open-label Study to Evaluatehe Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naive Adults with Chronic Hepatitis C Virus (HCV) Genotype 1, 2,4, 5 or 6Infection and Compensated Cirrhosis

  • Trial Applicant

    AbbVie

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Cheng-Yuan Peng Digestive System Department
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chi-Jen Chu Digestive System Department
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

5 Terminated

Audit

None

Principal Investigator Cheng-Yuan Peng 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Wan-Long Chuang Digestive System Department
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Chronic Hepatitis C Virus (HCV)

Objectives

To demonstrate the non-inferiority ofthe SVRL2 rates of 8 weeks oftreatment with the glecaprevir/pibrentasvir combination regimen to the historical SVR12 rate of 12 weeks of treatment with the glecaprevir/pibrentasvir in treatment nalve adults with chronic HCV GT 1. 2,4, 5 or 6 infection and compensated cirrhosis. The primary efficacy objective will beassessed across genotypes, in the Per-Protocol (PP) population . To assess the safety of 8 weeks of treatment with the glecaprevir/pibrentasvir combination regimen in treatment naive adults with chronicHCV GT L,2,4, 5 or 6 infection and compensated cirrhosis.

Test Drug

Glecaprevir、Pibrentasvir

Active Ingredient

Glecaprevir、Pibrentasvir

Dosage Form

tablet

Dosage

100 mg/40 mg

Endpoints

1. Efficacy: Plasma HCV RNA (IU/mL) will be assessed at each Treatment and Post-Treatment Visit.
2. Safety: Safety and tolerability will be assessed by monitoring adverse events,
physical examinations, clinical laboratory tests, 12-Lead ECGs and vital signs.
3. Quality of life: The Treatment Satisfaction Questionnaire-Medication (TSQM)
will be used to assess subjects' satisfaction with the treatments efficacy and side
effects. The Short Form 36 Version 2 Health Status Survey (SF-36v2) will be
used to assess the functional health and well-being of subjects. The Fatigue
Severity Scale (FSS) will be used to measure the severity of fatigue and its effect on lifestyle and activities.
4. Resistance: The following information will be tabulated and summarized: 1)
for all subjects with available samples, baseline polymorphisms at signature
resistance-associated amino acid positions relative to the appropriate
prototypic reference sequences; and 2) for subjects who do not achieve SVR12,
post-baseline substitutions relative to the corresponding baseline sequence in available samples.
5. Pharmacokinetics: Individual plasma concentrations of glecaprevir and
pibrentasvir will be tabulated and summarized.

Inclution Criteria

1) Male or female, at least 18 years of age at time of Screening (Taiwan only
includes male or female who is at least 20 year of age per local regulation.);
2) Screening laboratory result indicating HCV GT 1, 2, 4, 5 or 6 infection;
3) Positive plasma HCV antibody and HCV RNA viral load ≥ 1000 IU/mL at Screening;
4) Treatment-naïve to any approved or investigational anti-HCV medication;
5) Subject must be documented as cirrhotic, with a Child-Pugh score of ≤ 6.

Exclusion Criteria

1) Female subject who is pregnant, breastfeeding or is considering becoming
pregnant during the study, or for approximately 30 days after the last dose of study drug;
2) Any current or historical clinical evidence of decompensated cirrhosis,
including any current or past evidence of Child-Pugh B or C classification,
hepatic encephalopathy or variceal bleeding, radiographic evidence of small
ascites, or empiric use of lactulose/rifaximin. The use of beta blockers is not exclusionary;
3) Current HBV or HIV infection on screening tests, defined as:
•A positive HBsAg, or;
•HBV DNA > LLOQ in subjects with isolated positive anti-HBc (i.e., negative
HBsAg and Anti-HBs), or;
•A positive anti-human immunodeficiency virus antibody (HIV Ab).
4) HCV genotype performed by the central laboratory during screening
indicating genotype 3 infection or co-infection with more than one HCV genotype;
5) Screening laboratory analyses showing any of the following abnormal laboratory results:
•Alanine aminotransferase ALT > 10 × ULN
•Aspartate aminotransferase AST > 10 × ULN
•Total Bilirubin > 3.0 mg/dL
•Calculated creatinine clearance (CrCl, Cockcroft-Gault method) of < 50 mL/min
•Albumin < 2.8 mg/dL
•Hemoglobin < 10 g/dL
•Platelets < 50,000 cells/mm3

The Estimated Number of Participants

  • Taiwan

    21 participants

  • Global

    330 participants

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