Overview

8 Weeks Versus 12 Weeks of Elbasvir/Grazoprevir in Treatment-naïve CHC With Mild Fibrosis

Status:
Completed
Trial end date:
2018-09-19
Target enrollment:
0
Participant gender:
All
Summary
Grazoprevir plus elbasvir 12 to 16 weeks is now approved for chronic hepatitis C (CHC) genotype 1, 4, or 6 infection regardless liver disease severity. The current study aims to explore the efficacy and safety of 8-week grazoprevir/elbasvir in HCV-1b patients with mild liver fibrosis
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Treatments:
Elbasvir-grazoprevir drug combination
Criteria
Inclusion Criteria:

- Treatment naïve, HCV genotype 1b patients

- History of chronic HCV infection > 6 months

- Aged at least 20 years

- HCV RNA of 10,000 IU/mL or greater

- Fibroscan examination < 9.5 Kpa

- Negative serum or urine pregnancy test result (sensitivity of 25 mIU or better) for
women with childbearing potential within the 24-hour period before the first dose of
study drugs

- Female patients with childbearing potential must agree to use two reliable forms of
effective non-hormonal contraception (i.e., condoms, cervical barriers, intrauterine
device, spermicides, or sponge), at least 1 of which must be a physical barrier
method, during treatment till end of follow up.

- A hormonal contraception (in lieu of non-hormonal) plus a physical barrier method can
be used after end of treatment. All men with female partners of childbearing potential
must use two reliable forms of effective contraception (combined) during treatment and
till end of follow up

- Ability to participate and willingness to give written informed consent and to comply
with the study restrictions.

Exclusion Criteria:

- Prior experience of IFN or direct antiviral agents (DAA)

- Hepatitis B virus or HIV co-infection.

- Patients with experience of ascites, esophageal varices, or other evidence of hepatic
decompensation, and/or hepatocellular carcinoma.

- History of organ transplantation, except cornea transplantation.

- Hemoglobulin concentration < 11 mg/dl

- Platelet count < 75,000/mm3

- Albumin < 3 mg/dL

- History of active malignancy within the last 5 years, with the exception of localized
or in situ carcinoma (e.g., basal or squamous cell carcinoma of the skin)

- Poorly controlled diabetes (Hemoglobin A1c value ≥ 8.5%) and endocrine condition.

- Total bilirubin >2 mg/dL, unless subject has a documented history of Gilbert's
disease.

- Pregnant or lactating women.