- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03004625
Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAV
January 7, 2019 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
Treatment Efficacy and Safety of 12 Weeks of Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without Baseline NS5A Resistance-associated Variants (DARING)
A single-arm, multi-center study of HCV-1b patients without baseline non-structure protein (NS5A) resistance-associated variants.
Daclatasvir (60mg/day) and asunaprevir (100 mg twice daily) plus weight-based ribavirin (1000-1200 mg/d) for 12 weeks will be prescribed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Twenty-four weeks of Daclatasvir plus Asunaprevir provided a high treatment efficacy in hepatitis C virus genotype 1b (HCV-1b) patients.
Patients with non-structural protein 5A (NS5A) resistance associated variants (RAVs) would have an inferior response.
The investigators anticipate that12 weeks of daclatasvir and asunaprevir plus ribavirin is highly effective for HCV Genotype 1b patients without baseline NS5A RAVs.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kaohsiung, Taiwan, 807
- Kaohsiung Medical Universsity
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Treatment naïve, interferon-experienced, interferon-intolerant or interferon-ineligible, HCV genotype 1b patients with compensated liver disease.
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
- History of chronic HCV infection > 6 months
- Aged at least 20 years
- HCV RNA of 10,000 IU/mL or greater
- 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
- 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.
- 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
- Ability to participate and willingness to give written informed consent and to comply with the study restrictions.
Exclusion Criteria:
- The existence of baseline NS5A RAV "Lycine 31 (L31F/I/M)" or "Tyrosine93 (Y93H)", by using direct-sequencing with RAV of > 20%.
- Hepatitis B virus or HIV co-infection.
- Patients with experience of ascites, oesophageal varices, or other evidence of hepatic decompensation, and/or hepatocellular carcinoma.
- History of organ transplantation, except cornea transplantation.
- Hemoglobin concentration < 12 g/dl for male, 11 g/dl for female
- Platelet count < 50,000/mm3
- Prior direct antiviral agents (DAAs) experienced.
- 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)
- 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).
- Poorly controlled diabetes (Hemoglobin A1c value ≥ 8.5%) and endocrine condition.
- Total bilirubin >2 mg/dL, unless subject has a documented history of Gilbert's disease.
- Creatinine Clearance (CrCl) <30 mL/min (as estimated by Cockcroft and Gault)
- Pregnant or lactating women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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)
|
to evaluate the treatment efficacy and safety of the drug in HCV patients
Other Names:
to evaluate the treatment efficacy and safety of the drug in HCV patients
Other Names:
to evaluate the treatment efficacy and safety of the drug in HCV patients
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the treatment efficacy (SVR12) of 12 weeks of daclatasvir and asunaprevir plus ribavirin for HCV-1b patients without baseline RAVs
Time Frame: 6 months (including 3 months of treatment and 3 months of post-treatment follow-up peroid
|
SVR12 is defined as undetectable HCV RNA 12 weeks throughout 12 weeks of post-treatment follow-up peroid
|
6 months (including 3 months of treatment and 3 months of post-treatment follow-up peroid
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the number of participants with treatment-related adverse events of 12 weeks of daclatasvir and asunaprevir plus ribavirin for HCV-1b patients without baseline RAVs.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
April 1, 2018
Study Registration Dates
First Submitted
December 21, 2016
First Submitted That Met QC Criteria
December 28, 2016
First Posted (Estimate)
December 29, 2016
Study Record Updates
Last Update Posted (Actual)
January 9, 2019
Last Update Submitted That Met QC Criteria
January 7, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis
- Hepatitis C
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites
- Protease Inhibitors
- Ribavirin
- Asunaprevir
Other Study ID Numbers
- AI444-406
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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