Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will look at the safety and efficacy of 8 week and 12 week treatment with Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic hepatitis C genotype 4.
Patients with confirmed absence of cirrhosis will receive 8 weeks of treatment with Sofosbuvir and Simeprevir. Patients with confirmed presence of cirrhosis will receive 12 weeks of treatment with Sofosbuvir and Simeprevir. All patients will followed for 24 weeks post-treatment. Presence or absence of cirrhosis will be evaluated by FibroScan if no historical liver biopsy or FibroScan is available.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cirrhosis | Experimental | Patients with confirmed presence of cirrhosis will received 12 weeks of treatment with Sofosbuvir and Simeprevir |
|
| Non-Cirrhotic | Experimental | Patients with confirmed absence of cirrhosis will received 8 weeks of treatment with Sofosbuvir and Simeprevir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simeprevir | Drug | Simeprevir is a Hepatitis C Virus (HCV) NS3/4A protease inhibitor approved in the United States, Canada and Japan for the treatment of chronic HCV infection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virologic Response 12 Weeks after Treatment Completion (SVR12) | HCV RNA will be measured 12 weeks post-treatment to evaluate SVR | 12 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virologic Response 4 and 24 Weeks after Treatment Completion | HCV RNA will be measured 4 and 24 weeks post-treatment to evaluate SVR | 4 and 24 weeks post-treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter J Ruane, MD | Peter J. Ruane, MD, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter J. Ruane, MD, Inc. | Los Angeles | California | 90036 | United States |
Not provided
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069616 | Simeprevir |
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sofosbuvir | Drug | Sofosbuvir is a nucleotide NS5B polymerase inhibitor developed by Gilead Sciences Inc. and approved for the treatment of chronic HCV infection. |
|
|
| 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 |
| D006575 |
| Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |