An observational study in Chronic Hepatitis C, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-25.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Observational
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.
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 180 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 130 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male and female subjects with age >18 years old
Exclusion Criteria:
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 :500mg (two drugs in one tablet) orally once daily for 12 weeks.
Drug: DAAs
Ombitasvir/Paritaprevir: Ombitasvir two tablets orally once daily for 12 weeks; Paritaprevir one tablet orally twice daily for 12 weeks.
Drug: DAAs
Grazoprevir/elbasvir: 150mg (two drugs in one tablet) orally once daily for 12 weeks.
Drug: DAAs
Daclatasvir (60mg)one tablet once daily and Asunaprevir (100mg)one tablet twice daily for 24weeks
Drug: DAAs
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.
SVR(Sustained Virologic Response)12
The proportion of participants with HCV RNA undetectable at 12weeks after treatment completion
Time frame: 12 weeks
RVR (Rapid Virological Response)4
The proportion of participants with HCV RNA undetectable at 4 weeks after treatment
Time frame: 4 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Third Affiliated Hospital, Sun Yat-Sen University