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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting.
This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting.
The study will enroll chronically infected GT 1 patients who are treatment naïve or who have failed a regimen including pegIFN/RBV +/- telaprevir, boceprevir, or simeprevir.
In addition, up to 20 chronically infected GT1 patients who have traditionally been excluded from clinical trials due to mild to moderate renal insufficiency, irrespective of other co-morbid conditions including poorly controlled diabetes mellitus, high BMI, HIV infection will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single | Experimental | Ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) + databuvir (DSV) +/- ribavirin (RBV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin | Drug | OMB/PTV/r + DSV +/- RBV |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary analysis will be sustained virologic response 12 weeks after the last treatment dose (SVR12) for the all treated population. | Primary Analysis | 12 weeks after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of baseline resistance variants on SVR12 (subgroups: all RAVs, different classes of RAVs) | Secondary Analysis | 12 weeks after last treatment |
| Evaluate patient reported outcomes via the SF36v2 survey (subgroups: those who achieve SVR12 and those who do not) |
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Inclusion Criteria:
Age ≥ 18 years
Exclusion Criteria:
Currently taking or planning on taking any prohibited medications (see US PI)
Evidence of decompensated liver disease (Child-Pugh B or C) including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy
Abnormal lab values, including:
Alcohol use: >3 drinks per day consistently
Uncontrolled HIV or HBV coinfection
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| Name | Affiliation | Role |
|---|---|---|
| Fred Poordad, MD | American Research Corporation | Principal Investigator |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C585405 | paritaprevir |
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This is a Phase IV, open label, single arm study.
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Secondary Analysis. Comparison between baseline and end of treatment |
| 12 weeks after last treatment |
| Evaluate patient adherence (subgroups: those who achieve SVR12 and those who do not) | Secondary Analysis | 12 weeks after last treatment |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |