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Trial record 79 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

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

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ClinicalTrials.gov Identifier: NCT03887637
Recruitment Status : Not yet recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Chaoshuang Lin, Third Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment
Chronic Hepatitis C 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.


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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : March 30, 2019
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. SVR(Sustained Virologic Response)12 [ Time Frame: 12 weeks ]
    The proportion of participants with HCV RNA undetectable at 12weeks after treatment completion


Secondary Outcome Measures :
  1. RVR (Rapid Virological Response)4 [ Time Frame: 4 weeks ]
    The proportion of participants with HCV RNA undetectable at 4 weeks after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects with age >18 years old
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887637


Contacts
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Contact: Shuang C Lin, Professor 008613794365980 linchaoshuang@126.com
Contact: Wei W Deng, Student 008613342811669 116536049@qq.com

Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Shuang C Lin, Professor Third Sun Yat Sen

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Responsible Party: Chaoshuang Lin, Professor/Chief physician, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03887637     History of Changes
Other Study ID Numbers: LinChaoShuang
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Velpatasvir
Asunaprevir
Antiviral Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action