An Observational Post Marketing study to check the Safety and Effectiveness of Sofosbuvir based treatment in Patients with Chronic Hepatitis C
- Conditions
- Health Condition 1: null- chronic hepatitis C (CHC) virusinfectionHealth Condition 2: K739- Chronic hepatitis, unspecified
- Registration Number
- CTRI/2017/08/009547
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. A written, signed and dated Data Sharing Informed Consent
from all patients/LAR
2. Either gender with age 18 years and above
3. Patients having confirmed diagnosis of chronic hepatitis C virus
infection who are either treatment naïve or with prior treatment
experience.
1. Known hypersensitivity to Sofosbuvir or ribavirin or peginterferon
alfa, daclatasvir or any of its components
2. Contraindications to Sofosbuvir or any of the components of
the combination regimen
3. Women who are pregnant or may become pregnant and men
whose female partners are pregnant
4. Women of child bearing potential who are unwilling to use
adequate contraceptive measures unless abstinence is
considered adequate in the opinion of the investigator.
5. Any other condition as per the discretion of investigator
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method