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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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22 May 2017 |
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Main ID: |
ACTRN12617000263392 |
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Date of registration:
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20/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Fixed twelve weeks duration versus response tailored course of dual Sofosbuvir/Daclatasvir therapy in Egyptian adult and adolescent patients with chronic hepatitis C infection (HCV).
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Scientific title:
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Fixed twelve weeks duration versus response tailored course of dual Sofosbuvir/Daclatasvir therapy in Egyptian adult and adolescent patients with chronic hepatitis C infection (HCV).
prospective, randomized, open-label, non-inferiority, multi-center study |
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Date of first enrolment:
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5/06/2016 |
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Target sample size:
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130 |
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Recruitment status: |
Completed |
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URL:
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http://www.anzctr.org.au/ACTRN12617000263392.aspx |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial
Parallel |
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Phase:
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Phase 3 / Phase 4
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Key inclusion & exclusion criteria
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Health Condition(s) or Problem(s) studied
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chronic virus hepatitis C infection
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Intervention(s)
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Response guided duration of therapy:
Dual treatment with weight based Gratisovir (Sofosbuvir) + weight based Daclatasvir for doses according to the following table:
* Gratisovir (Sofosbuvir) 400mg / 200 mg tablets on daily doses based on body weight (20 – 29.9 Kg will take one 200 mg tablet daily); (30 – 39.9 Kg will take 1.5 tablets daily); (> 40 Kg/adults will take 2 tablets (or 1 table of 400 mg) once daily)
* + Daclatasvir 60 mg/30 mg tablets on daily doses based on body weight or according to the following schedule:
(20 – 30 Kg: will take 30 mg once daily),
(31 – 45 Kg: 45 mg once daily)
(> 45 Kg/adults: 60 mg once daily)
And for a duration tailored according to the very rapid virological response (vRVR) for each patient::
* Those who will show very show rapid virological response (undetectable HCV RNA at week 2) will be treated with 8 weeks duration.
* Rest will complete the 12 weeks duration.
Adherence to the study protocol and medications will be monitored at each visit by counting the number of pills (if any) remained in the medication packets.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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