Chronic Hepatitis CNCT03887637
Real-world Effectiveness and Safety of Treatment With DAAs in Patients With CHC(Chronic Hepatitis C)
An observational study of Chronic Hepatitis C, run by Third Affiliated Hospital, Sun Yat-Sen University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- DAAs
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects with age >18 years old
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Being tested
- DAAs
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAAsDrug
Patients with CHC and cirrhosis who fulfills the indication of antiviral therapy will be administered with DAAs treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: DAAs | |
| Sofosbuvir/ Velpatasvir therapy | Sofosbuvir/ Velpatasvir :500mg (two drugs in one tablet) orally once daily for 12 weeks. Receives: 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. Receives: Drug: DAAs | |
| Grazoprevir/elbasvir therapy | Grazoprevir/elbasvir: 150mg (two drugs in one tablet) orally once daily for 12 weeks. Receives: Drug: DAAs | |
| Daclatasvir/Asunaprevir therapy | Daclatasvir (60mg)one tablet once daily and Asunaprevir (100mg)one tablet twice daily for 24weeks Receives: 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. Receives: Drug: DAAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR(Sustained Virologic Response)12
The proportion of participants with HCV RNA undetectable at 12weeks after treatment completion
Measured: 12 weeks
Secondary outcomes (1)
RVR (Rapid Virological Response)4
The proportion of participants with HCV RNA undetectable at 4 weeks after treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start30 Mar 2019 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaoshuang Lin, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Shuang C Lin, Professor, Principal investigator, Third Sun Yat Sen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887637
- Sponsor's protocol ID
- LinChaoShuang
- Status last verified
- Mar 2019
- First submitted
- 15 Mar 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03887637
- Acronym / sponsor ID
- LinChaoShuang
- Conditions
- Chronic Hepatitis C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 Mar 2019 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Danoprevir Sodium triple therapy | – | Drug: DAAsDNV(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. |
| Sofosbuvir/ Velpatasvir therapy | – | Drug: DAAsSofosbuvir/ Velpatasvir :500mg (two drugs in one tablet) orally once daily for 12 weeks. |
| Ombitasvir/Paritaprevir therapy | – | Drug: DAAsOmbitasvir/Paritaprevir: Ombitasvir two tablets orally once daily for 12 weeks; Paritaprevir one tablet orally twice daily for 12 weeks. |
| Grazoprevir/elbasvir therapy | – | Drug: DAAsGrazoprevir/elbasvir: 150mg (two drugs in one tablet) orally once daily for 12 weeks. |
| Daclatasvir/Asunaprevir therapy | – | Drug: DAAsDaclatasvir (60mg)one tablet once daily and Asunaprevir (100mg)one tablet twice daily for 24weeks |
| Danoprevir Sodium/Sofosbuvir therapy | – | Drug: DAAsDanoprevir Sodium: 100mg (one tablet) orally twice daily for 12 weeks;Sofosbuvir:400mg (one tablet) orally once daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects with age >18 years old
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAAsPatients with CHC and cirrhosis who fulfills the indication of antiviral therapy will be administered with DAAs treatment. | Drug | Daclatasvir/Asunaprevir therapy, Danoprevir Sodium triple therapy, Danoprevir Sodium/Sofosbuvir therapy, Grazoprevir/elbasvir therapy, Ombitasvir/Paritaprevir therapy, Sofosbuvir/ Velpatasvir therapy |
Primary outcome
SVR(Sustained Virologic Response)12
Time frame: 12 weeks
The proportion of participants with HCV RNA undetectable at 12weeks after treatment completion
1 secondary outcome
RVR (Rapid Virological Response)4
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuang C Lin, Professor principal investigator
Third Sun Yat Sen
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C, run by Third Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuang C Lin, Professor (008613794365980, linchaoshuang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR(Sustained Virologic Response)12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.