CTRI/2016/11/007468
Other
未知
A Non-Interventional, Multicenter, Prospective, Observational Study to UNdersTand Usage and Effect of LEdipAsvirplusSofosbuvir Combination for the Treatment of Adults with Chronic Genotype 1 HCV Infections - UNLEASH
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Chronic Hepatitis C
- Sponsor
- Torrent Pharmaceuticals Ltd
- Enrollment
- 88
- Status
- Other
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patient willing to provide informed consent
- •2\.Female or male patient aged 18 years or above
- •3\.Patients chronically infected with hepatitis C virus (HCV) genotype 1
- •4\.Patient found positive for HCV RNA test
- •5\.Screening laboratory values within clinically acceptable range
- •6\.Treatment naïve and experienced patients with or without cirrhosis(compensated as well as decompensated)
- •7\.Patients who are started on ledipasvir plus sofosbuvir combination treatment in normal clinical practice setting
- •8\.Patients must provide written consent form to use personal and/or health data prior to the entry into the study
Exclusion Criteria
- •1\.HCV Genotypes other than genotype\-1 infection; mixed genotype infections
- •2\.Pregnant or nursing female or male with pregnant female partner
- •3\.Female or male with female partner planning to become pregnant while enrolled in this study
- •4\.Co\-infection with HIV or hepatitis B virus (HBV)
- •5\.Patients of hepatocellular carcinoma
- •6\.History of clinically significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol
- •7\.Any contraindication for the administration of direct acting antivirals Ledipasvir and sofosbuvir
- •8\.Patients participating in other clinical trials
Outcomes
Primary Outcomes
Not specified
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