Real-world Effectiveness and Safety of Treatment With DAAs in Patients With CHC(Chronic Hepatitis C) (NCT03887637) | Clinical Trial Compass
UnknownNot Applicable
Real-world Effectiveness and Safety of Treatment With DAAs in Patients With CHC(Chronic Hepatitis C)
180 participantsStarted 2019-03-30
Plain-language summary
This is a multi-center, open-label clinical study. This study was aimed to assess the real-world effectiveness and safety of treatment with listed DAAs in patients with CHC and cirrhosis in Southern area of China.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female subjects with age \>18 years old.
* HCV RNA ≥1×103IU/mL
* Genotype 1-6 HCV infection.
* Confirmed CHC defined as: (1)Confirmed HCV infection more than 6 months at baseline, including anti-HCV positive or HCV RNA positive for at least 6 months; (2)Confirmed HCV infection by liver biopsy one year before baseline.
* Negative pregnancy test for females of childbearing potential (18 years old to one year after menopause) at screening.
* Males and females of childbearing potential should agree to take mechanic contraceptives from screening to at least 6 months after discontinuation of treatment.
* Informed of, willing and able to comply with all of the protocol requirements and the investigational nature of the study.
* A signed written informed consent from patient.
Exclusion Criteria:
* History of clinically significant medical condition associated with other chronic liver disease (including hemochromatosis, autoimmune hepatitis, Wilson's disease, α1-antitrypsin deficiency, alcoholic liver disease, drug-induced liver injury).
* Stomach disorder that could interfere with the absorption of the study drug.
* Serious or active medical or psychiatric illness. If the participant has received more than 12 months of treatment and the condition is stable, or the participant does not need any medicine during the previous 12 months, the participant is allowed to enrollment.
* Uncontrolled serious cardiovascular disease (such as ventricular tachyarrhy…
What they're measuring
1
SVR(Sustained Virologic Response)12
Timeframe: 12 weeks
Trial details
NCT IDNCT03887637
SponsorThird Affiliated Hospital, Sun Yat-Sen University