CClinicalTrials.gg
Status unknownNCT03887637Updated Mar 25, 2019

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

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

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

03

In context

Hepatitis A

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Male and female subjects with age >18 years old

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugDAAs

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

06

What researchers measure

Primary outcomes

  1. SVR(Sustained Virologic Response)12

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

    Time frame: 12 weeks

Secondary outcomes

  1. RVR (Rapid Virological Response)4

    The proportion of participants with HCV RNA undetectable at 4 weeks after treatment

    Time frame: 4 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03887637
Lead sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Responsible party
Chaoshuang Lin (Professor/Chief physician, Third Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Mar 25, 2019
Start date
Mar 30, 2019 (estimated)
Primary completion
Aug 30, 2019 (estimated)
Completion
Sep 30, 2019 (estimated)
Last update
Mar 25, 2019

Study contacts

Shuang C Lin, Professor
Contact
linchaoshuang@126.com
008613794365980
Wei W Deng, Student
Contact
116536049@qq.com
008613342811669
Shuang C Lin, Professor
principal investigator · Third Sun Yat Sen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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