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

NCT03887637 | Unknown

• 1 other identifier: LinChaoShuang
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• SVR(Sustained Virologic Response)12

  The proportion of participants with HCV RNA undetectable at 12weeks after treatment completion

  12 weeks

Secondary Outcomes (1)

• RVR (Rapid Virological Response)4

  4 weeks

Study Arms (6)

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

Sofosbuvir/ Velpatasvir therapy

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

Drug: DAAs

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

Grazoprevir/elbasvir therapy

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

Drug: DAAs

Daclatasvir/Asunaprevir therapy

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

Drug: DAAs

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

Interventions

DAAs DRUG

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

Daclatasvir/Asunaprevir therapy; Danoprevir Sodium triple therapy; Danoprevir Sodium/Sofosbuvir therapy; Grazoprevir/elbasvir therapy; Ombitasvir/Paritaprevir therapy; Sofosbuvir/ Velpatasvir therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects with age \>18 years old

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shuang C Lin, Professor

  Third Sun Yat Sen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuang C Lin, Professor

CONTACT

008613794365980; linchaoshuang@126.com

Wei W Deng, Student

CONTACT

008613342811669; 116536049@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Chief physician

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 25, 2019
• Study Start: March 30, 2019
• Primary Completion: August 30, 2019
• Study Completion: September 30, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03