Safety And Effectiveness Of Sofosbuvir And Daclatasvir In Patients Who Have Thalassemia With Hepatitis C Virus Infection And Who Are 6 years To 18 Years Old
Not Applicable
Completed
- Conditions
- Health Condition 1: B182- Chronic viral hepatitis CHealth Condition 2: D56- Thalassemia
- Registration Number
- CTRI/2020/06/025910
- Lead Sponsor
- Riten Kumar Samadder
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
All Patients Of Chronic Hepatitis C In Thalassemic Patient With 6 To 18 Years of Age With Any Level Of Detectable HCV RNA Is To Be Included In The Study
Patients Could Be Either Treatment Naive Or Interferon Experienced
Exclusion Criteria
The Legal Guardians/Parents Of The Patients Who Are Not Willing To Give Written Consent
Patients Who Are HIV Positive
Patients Who Were HBsAg Positive
Patient With HCV RNA Below Detection Level At Entry To The Trial
Patient With Associated Tuberculosis Or Malignancy
Presence of Cirrhosis
Pregnancy
Presence Of Any Major Comorbidities Like Heart Failure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To Evaluate Safety And Efficacy Of Sofosbuvir And Daclatasvir In Patients With Thalassemia With Chronic HCV Infection <br/ ><br> <br/ ><br>Timepoint: 3 Months Of Treatment Followed By 3 Months Of Follow Up
- Secondary Outcome Measures
Name Time Method To Check For Any Biochemical Improvement At The End Of TreatmentTimepoint: 3 Months Of Treatment Followed By 1 Month Of Follow Up;To Look For Development Of Any Side Effect Of These Two Drugs During The TrialTimepoint: 3 Months Of Treatment Followed By 1 Month Of Follow Up