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

NCT ID: NCT03887637

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-30
• Study Completion Date: 2019-09-30

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.

Conditions

Chronic Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Danoprevir Sodium triple therapy

DNV(Danoprevir Sodium)/PegIFNα(Peginterferon α-2a)/RBV(Ribavirin) : (1) DNV : 100mg (one tablet) orally twice daily for 12 weeks. (2) PegIFNα: 180ug subcutaneous infection on abdomen or thigh once a week for 12 weeks. (3) RBV: 500mg (5 tablets) orally twice daily for 12 weeks in patients weighing less than 75kg; 600mg (6 tablets) orally twice daily for 12 weeks in patients weighing ≥75kg.

Dosing time: In the morning, participants will be instructed to take DNV and RBV with food or one hour after food. The drugs are not allowed to be cut or divided. The interval between DNV and RBV dosing time should be 12±2 hours.

DAAs

Intervention Type: DRUG

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

Sofosbuvir/ Velpatasvir therapy

Sofosbuvir/ Velpatasvir :500mg (two drugs in one tablet) orally once daily for 12 weeks.

DAAs

Intervention Type: DRUG

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

Ombitasvir/Paritaprevir therapy

Ombitasvir/Paritaprevir: Ombitasvir two tablets orally once daily for 12 weeks; Paritaprevir one tablet orally twice daily for 12 weeks.

DAAs

Intervention Type: DRUG

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

Grazoprevir/elbasvir therapy

Grazoprevir/elbasvir: 150mg (two drugs in one tablet) orally once daily for 12 weeks.

DAAs

Intervention Type: DRUG

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

Daclatasvir/Asunaprevir therapy

Daclatasvir (60mg)one tablet once daily and Asunaprevir (100mg)one tablet twice daily for 24weeks

DAAs

Intervention Type: DRUG

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

Danoprevir Sodium/Sofosbuvir therapy

Danoprevir Sodium: 100mg (one tablet) orally twice daily for 12 weeks;Sofosbuvir:400mg (one tablet) orally once daily for 12 weeks.

DAAs

Intervention Type: DRUG

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

Interventions

DAAs

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Chaoshuang Lin

Professor/Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuang C Lin, Professor

Role: PRINCIPAL_INVESTIGATOR

Third Sun Yat Sen

Central Contacts

Shuang C Lin, Professor

Role: CONTACT

linchaoshuang@126.com

008613794365980

Wei W Deng, Student

Role: CONTACT

116536049@qq.com

008613342811669

Other Identifiers

LinChaoShuang

Identifier Type: -

Identifier Source: org_study_id