8 Weeks Versus 12 Weeks of Elbasvir/Grazoprevir in Treatment-naïve CHC With Mild Fibrosis (NCT03186365) | Clinical Trial Compass
CompletedPhase 3
8 Weeks Versus 12 Weeks of Elbasvir/Grazoprevir in Treatment-naïve CHC With Mild Fibrosis
Taiwan82 participantsStarted 2017-06-12
Plain-language 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
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
the rate of subjects with undetectable HCV RNA 12 weeks post end-of-treatment
Timeframe: through study completion, an average of 5.5 months
Trial details
NCT IDNCT03186365
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital