Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAV
NCT ID: NCT03004625
Last Updated: 2019-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
70 participants
INTERVENTIONAL
2016-11-30
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study Arm
HCV-1b patients without baseline NS5A resistance-associated variants receiving Daclatasvir (60mg/day) and asunaprevir (100 mg twice daily) plus weight-based ribavirin (1000-1200 mg/d) for 12 weeks. (daclatasvir, asunaprevir plus ribavirin)
daclatasvir
to evaluate the treatment efficacy and safety of the drug in HCV patients
asunaprevir
to evaluate the treatment efficacy and safety of the drug in HCV patients
Ribavirin
to evaluate the treatment efficacy and safety of the drug in HCV patients
Interventions
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daclatasvir
to evaluate the treatment efficacy and safety of the drug in HCV patients
asunaprevir
to evaluate the treatment efficacy and safety of the drug in HCV patients
Ribavirin
to evaluate the treatment efficacy and safety of the drug in HCV patients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with compensated liver cirrhosis will be capped at 40%.
Cirrhosis is defined as any one of the following:
* Liver biopsy showing cirrhosis
* Fibroscan indicative of cirrhosis as evidenced by a result \> 12.5 kilopascal
Absence of cirrhosis is defined as any one of the following:
* Liver biopsy within 2 years of Screening showing absence of cirrhosis
* Fibroscan within 6 months of Baseline with a result of ≤ 12.5 kilopascal
3. History of chronic HCV infection \> 6 months
4. Aged at least 20 years
5. HCV RNA of 10,000 IU/mL or greater
6. Negative serum or urine pregnancy test result (sensitivity of 25 international units or better) for women with childbearing potential within the 24-hour period before the first dose of study drugs
7. Female patients with childbearing potential must agree to use two reliable forms of effective non-hormonal contraception (i.e., condoms, cervical barriers, intrauterine device, spermicides, or sponge), at least 1 of which must be a physical barrier method, during treatment and for at least 6 months following the last dose of ribavirin.
8. A hormonal contraception (in lieu of non-hormonal) plus a physical barrier method can be used after end of treatment. All men with female partners of childbearing potential must use two reliable forms of effective contraception (combined) during treatment and for 6 months following the last dose of ribavirin
9. Ability to participate and willingness to give written informed consent and to comply with the study restrictions.
Exclusion Criteria
2. Hepatitis B virus or HIV co-infection.
3. Patients with experience of ascites, oesophageal varices, or other evidence of hepatic decompensation, and/or hepatocellular carcinoma.
4. History of organ transplantation, except cornea transplantation.
5. Hemoglobin concentration \< 12 g/dl for male, 11 g/dl for female
6. Platelet count \< 50,000/mm3
7. Prior direct antiviral agents (DAAs) experienced.
8. History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma (e.g., basal or squamous cell carcinoma of the skin)
9. History of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia's requiring ongoing treatment, unstable angina or other unstable, uncontrolled or significant cardiovascular disease within 6 months).
10. Poorly controlled diabetes (Hemoglobin A1c value ≥ 8.5%) and endocrine condition.
11. Total bilirubin \>2 mg/dL, unless subject has a documented history of Gilbert's disease.
12. Creatinine Clearance (CrCl) \<30 mL/min (as estimated by Cockcroft and Gault)
13. Pregnant or lactating women.
20 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
National Taiwan University Hospital
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
China Medical University Hospital
OTHER
National Cheng-Kung University Hospital
OTHER
Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Ming-Lung Yu, MD., PhD.
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Medical University
Locations
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Kaohsiung Medical Universsity
Kaohsiung City, , Taiwan
Countries
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Other Identifiers
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AI444-406
Identifier Type: -
Identifier Source: org_study_id
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