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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: DAAs

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.

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects with age >18 years old

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: DAAs; 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.	Drug: DAAs; 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.	Drug: DAAs; 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.	Drug: DAAs; 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	Drug: DAAs; 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.	Drug: DAAs; Patients with CHC and cirrhosis who fulfills the indication of antiviral therapy will be administered with DAAs treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SVR(Sustained Virologic Response)12	The proportion of participants with HCV RNA undetectable at 12weeks after treatment completion	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RVR (Rapid Virological Response)4	The proportion of participants with HCV RNA undetectable at 4 weeks after treatment	4 weeks

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: Shuang C Lin, Professor, Third Sun Yat Sen

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 30, 2019
• Primary Completion (ANTICIPATED): August 30, 2019
• Study Completion (ANTICIPATED): September 30, 2019

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (ACTUAL): March 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic
• Other Study ID Numbers: LinChaoShuang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No