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Phase 2a study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 in combination with Ribavirin for a 12-week treatment duration in treatment-naïve participants with genotype 4 hepatitis C virus (HCV) infection.
A study to evaluate the safety and effect of treatment with experimental antiviral drugs in combination with ribavirin in treatment-naïve participants with genotype 4 hepatitis C infection. The study will test the safety and effects of this alternative treatment for up to 12 weeks. Secondary objectives of this study are to determine the pharmacokinetics of the study drugs when co-administered, and to evaluate HCV RNA kinetics during treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin |
|
| Group 2 | Experimental | 12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faldaprevir | Drug |
|
| |
| TD-6450 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving 12-week sustained virologic response following treatment with 2 direct acting anti-virals and ribavirin in Genotype 4 Hepatitis C infected adults | Post Treatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with virologic response at Week 12 (HCV RNA less than lower limit of quantitation at end of therapy with Faldaprevir plus TD-6450 plus ribavirin) | Week 12 | |
| Percentage of subjects with virologic response 2, 4 and 8 weeks after treatment completion (HCV RNA less than lower limit of quantitation at 2, 4 and 8 weeks after end of therapy with Faldaprevir plus TD-6450 plus ribavirin) |
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Inclusion Criteria:
Chronic genotype 4 hepatitis C infection and HCV RNA ≥ 10^4 IU/mL at screening
Hepatitis C virus treatment naive, defined as defined as having never received a direct acting anti-viral (DAA), and as having received ≤ 8 weeks of interferon ≥ 6 months prior to screening
Absence of cirrhosis as defined by one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tarek Hassanein, MD | Southern California Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California Research Center | Coronado | California | 92118 | United States |
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| Drug |
|
| Ribavirin | Drug |
|
|
| Post Treatment Weeks 2 to 8 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| C552340 | faldaprevir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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