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| ID | Type | Description | Link |
|---|---|---|---|
| AI443-128 | Other Grant/Funding Number | Bristol-Myers Squibb |
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| Name | Class |
|---|---|
| VA Long Beach Healthcare System | FED |
| National Cancer Institute (NCI) | NIH |
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 8 weeks |
|
| Arm 2 | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 6, 8 or 12 weeks |
|
| Arm 3 | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 4 weeks |
|
| Arm A | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 8 weeks |
|
| Arm B | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 6, 8 or 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCV/ASV/BMS-791325 | Drug | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virologic Response | Proportion of treated subjects in each enrolled arm with sustained virologic response (SVR)12. SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) target detected or target not detected (TD/TND) at post treatment Week 12 | Post treatment week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | On treatment safety, as measured by frequency of serious adverse events (SAEs) and adverse events (AEs), discontinuations due to AEs, and rates and grades of select laboratory abnormalities including liver function tests and hematology laboratory abnormalities in each arm | Up to end of treatment (+7 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy R. Morgan, MD | VA Long Beach Healthcare System/Southern California Institute for Research and Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Long Beach Healthcare System | Long Beach | California | 90822 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 4, 2018 | |
| Reset | Jun 6, 2018 | |
| Release | Sep 19, 2018 |
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| Arm C | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 4 weeks |
|
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| DCV/ASV/BMS-791325 + RBV | Drug | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day |
|
| Sustained virologic response |
Proportion of treated subjects in each arm with SVR2, SVR4 and SVR 24, defined as HCV RNA < lower limit of quantification (LLOQ) target detected or target not detected (TD/TND) at post treatment Weeks, 2, 4, and 24 respectively |
| 2, 4 and 24 weeks post-treatment |
| Post treatment virologic response | To assess the proportion of subjects who achieve sustained virologic response (SVR) 2, SVR4 and SVR24. | post treatment Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24) |
| On treatment virologic response | To assess antiviral activity, as measured by the proportion of subjects who achieve HCV RNA \ | On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 |
| Virologic failure | To assess the proportion of subjects with virologic failure (including on treatment virologic breakthrough and relapse) and evaluate the emergence of viral resistant mutations. | On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24 |
| Day 2 positive predictive value | To assess the predictive value of Day 2 virologic response on sustained virologic response (SVR) 12 | Post treatment Week 12 |
| Interferon lambda genotype and virologic response | To compare the virologic response of subjects by genotype for interferon (IFN) lambda variants [' IL28B' and IFNL4-ΔG] | On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24 |
| Reset | Oct 19, 2018 |
| Release | Dec 26, 2018 |
| Reset | Jan 17, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 4, 2018 | Jun 6, 2018 | |||
| Sep 19, 2018 | Oct 19, 2018 | |||
| Dec 26, 2018 | Jan 17, 2019 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006505 | Hepatitis |
| D006521 | Hepatitis, Chronic |
| D019698 | Hepatitis C, Chronic |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D012327 | RNA Virus Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C549273 | daclatasvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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