Clinical trial NCT03887637: Real-world Effectiveness and Safety of Treatment With DAAs in Patients With CHC(Chronic Hepatitis C)
Official title: Real-world Effectiveness and Safety of Treatment With Direct Antiviral Agents (DAAs) in Patients With Chronic Hepatitis C and Cirrhosis in Southern Area of China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis C
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects with age \>18 years old

Brief 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.

Detailed description: 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.

The primary objectives of this study is as follows:

To access the effectiveness and safety of 12-week/24-week treatment with listed DAAs in patients with CHC and cirrhosis in real-world clinical practice in Southern area of China. The proportion of participants with SVR12(Undetectable HCV RNA at 12 weeks after treatment completion RNA:Hepatitis C virus ribonucleic acid) was evaluated.

This study aims to enroll 30 patients with CHC and cirrhosis in each treatment group.

Patients with CHC and cirrhosis who fulfills the indication of antiviral therapy will be administered with DAAs treatment. After 12-week/2-week treatment, all the patients will be followed up for 12 weeks.

Eligibility criteria: 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 tachyarrhythmia, myocardial infarction, angina or coronary disease); or uncontrolled hypertension (systolic pressure ≥160mmHg and/or diastolic pressure ≥100mmHg); or clinically relevant ECG abnormalities.
* Serious respiratory or renal diseases.
* Serious hematological diseases or increased risk of anemia (such as Mediterranean anemia, sickle cell disease, spherocytosis, gastrointestinal bleeding).
* Uncontrolled diabetes or other endocrinological diseases.
* Suspension of malignant tumor.
* Participant who has received organ or bone-marrow allograft, or plans to receive organ transplantation during the treatment.
* Any confirmed significant allergic reactions against any drug, or the therapeutic drug and its metabolites.
* Uncontrolled autoimmune diseases, including but not limited to myositis, hepatitis, interstitial lung disease, interstitial nephritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, thyroiditis, psoriasis, rheumatoid arthritis, et al.
* Anti-HAV (IgM), anti-HEV (IgM) or anti-HIV positive. HBsAg-positive is not limited.
* Pregnancy or breast-feeding (non-breast-feeding is not included) female.
* History of drug and/or alcohol abuse within 6 months before screening that could interfere with evaluation.
* Participation in other clinical trial or an investigational drug 3 months before screening.

Primary outcomes:
measure: SVR(Sustained Virologic Response)12
timeFrame: 12 weeks
Secondary outcomes:
measure: RVR (Rapid Virological Response)4
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Third Sun Yat Sen
name: Shuang C Lin, Professor
role: PRINCIPAL_INVESTIGATOR
References: