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| ID | Type | Description | Link |
|---|---|---|---|
| TMC435HPC4012 | Other Identifier | Janssen-Cilag Ltd. |
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The purpose of this study is to describe the genetic diversity of Hepatitis C virus (HCV) NS3/4a protease and NS5A protein of HCV in participants with chronic disease naive-drug or previously failed to double therapy (Peg-interferon and Ribavirin) and to identify the frequency of natural polymorphisms in HCV NS3/4a protease and NS5A protein that are associated with direct-acting antivirals (DAAs)-resistance.
This is a multicenter, observational/non-interventional, cross-sectional study to describe the genetic diversity of and to identify the natural polymorphisms in HCV NS3/4a protease and NS5A protein of hepatitis C virus in Brazilian participants with chronic HCV infection. Brazilian participants with Genotype 1 HCV infection treatment naive participants or previously failed to double therapy (Peg-interferon-α and Ribavirin) will be included in the trial and will constitute the trial population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Brazilian participants with Genotype 1 HCV infection treatment naive participants or previously failed to double therapy (Peg-interferon-α and Ribavirin) will be included in the trial and will constitute the trial population. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HCV NS3/4a Protease and NS5A Protein | After extraction of HCV RNA from collected blood samples, the sequences of the NS3/4A and NS5A genes of HCV will be amplified by reverse transcription polymerase chain reaction (RTPCR) using specific primers for each genomic region. PCR products will be sequenced subsequently by direct sequencing. Detection of natural polymorphisms will be analyzed a comparison of the each sequence with the subtype consensus sequence. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Brazilian participants with Genotype 1 HCV infection treatment naive patients or previously failed to double therapy (Peg-interferon-α and Ribavirin) will be included in the trial.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd. Clinical Trial | Janssen-Cilag Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belém | Brazil | |||||
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The total blood volume to be collected will be approximately 15 milliliters (mL) (3 tubes, 5mL each). Fasting is not required. The blood sample collection scheme was designed to collect the minimum number of blood samples that is necessary to accomplish the study objective. Blood samples will be frozen and incinerated 30 days after blood collection at the national central laboratory.
| Goiânia |
| Brazil |
| Porto Alegre | Brazil |
| Porto Velho | Brazil |
| Salvador | Brazil |
| São Paulo | Brazil |
| ID | Term |
|---|---|
| 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 |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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