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| Name | Class |
|---|---|
| Chang Gung Memorial Hospital | OTHER |
| National Taiwan University Hospital | OTHER |
| Taipei Veterans General Hospital, Taiwan | OTHER_GOV |
| China Medical University Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| daclatasvir | Drug | to evaluate the treatment efficacy and safety of the drug in HCV patients |
|
| 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 | 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 |
| Measure | Description | 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. | 3 months |
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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:
Absence of cirrhosis is defined as any one of the following:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Ming-Lung Yu, MD., PhD. | Kaohsiung Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical Universsity | Kaohsiung City | 807 | Taiwan |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 9, 2019 | |
| Reset | Jul 26, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 9, 2019 | Jul 26, 2019 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C549273 | daclatasvir |
| C571889 | asunaprevir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| OTHER |
| National Cheng-Kung University Hospital | OTHER |
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| asunaprevir | Drug | to evaluate the treatment efficacy and safety of the drug in HCV patients |
|
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| Ribavirin | Drug | to evaluate the treatment efficacy and safety of the drug in HCV patients |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |