Real-world Effectiveness and Safety of Treatment With DAAs in Patients With CHC(Chronic Hepatitis C)

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03887637
• Other study ID #: LinChaoShuang
• Status: Not yet recruiting
• Start date: March 30, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: March 2019
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Shuang C Lin, Professor
• Phone: 008613794365980
• Email: linchaoshuang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: September 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, a1-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.

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• DAAs
Patients with CHC and cirrhosis who fulfills the indication of antiviral therapy will be administered with DAAs treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR(Sustained Virologic Response)12	The proportion of participants with HCV RNA undetectable at 12weeks after treatment completion	12 weeks
Secondary	RVR (Rapid Virological Response)4	The proportion of participants with HCV RNA undetectable at 4 weeks after treatment	4 weeks