Health Condition 1: B182- Chronic viral hepatitis C Health Condition 2: D56- Thalassemia
Conditions
Interventions
Intervention1: Non-Randomized Clinical Trial: Group A Age Group 6 Years To 11 Years Will Receive Sofosbuvir 200 Mg And Daclatasvir 30 Mg Combination For Duration Of 3 Months
Group B Age Group 12 Yea
Sponsors
Riten Kumar Samadder
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Evaluate Safety And Efficacy Of Sofosbuvir And Daclatasvir In Patients With Thalassemia With Chronic HCV Infection Timepoint: 3 Months Of Treatment Followed By 3 Months Of Follow Up | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactRiten Kumar Samadder
IPGMER And SSKM Hospital
Outcome results
None listed