Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
This trial is active, not recruiting.
|Condition||chronic hepatitis c|
|Start date||September 2014|
|End date||November 2016|
|Trial size||3000 participants|
|Trial identifier||NCT02250001, AI444-244|
The primary objective of this study is: To evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in Japanese patients chronically infected with HCV GT-1.
Patients who are beginning to receive the treatment with DCV/ASV under the approved indications, dosage, and administration will be included in this study
The real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of Daclatasvir/Asunaprevir (DCV/ASV) dual therapy in Japanese patients chronically infected with Hepatitis C virus Genotype 1 (HCV GT-1)
time frame: 28 weeks
Antiviral activity as determined by the proportion of patients with sustained virologic response at 24 weeks post-treatment Sustained virologic response at 24 weeks post-treatment (SVR24)
time frame: 48 weeks
Male or female participants at least 20 years old.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Patients who are initiating DCV and ASV treatment for the first time under the approved indications, dosage, and administration will be included in this study
|Official title||Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C|
|Description||Time Perspective: Other - For patients who are treated before the contract between Bristol-Myers Kabushiki Kaisha (BMKK) and the treating physician is initiated, patient data will be collected retrospectively after the contract is signed. Data will be collected prospectively for patients who initiate DCV/ASV treatment after the contract is initiated Patient Registry study - Yes; 48 weeks (Treatment: 24 weeks, Follow up: 24 weeks)|
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