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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02804386 |
Date of registration:
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07/06/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon
HEATS |
Scientific title:
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Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon (Hepatitis Eradication Accuracy Trial of Sofosbuvir): An Observational Non-interventional Real Life Trial |
Date of first enrolment:
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June 2016 |
Target sample size:
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573 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02804386 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Zahid Azam, FCPS |
Address:
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Telephone:
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Email:
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Affiliation:
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DUHS |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men and women, 18 years of age or older,
- Treatment -Naïve and not responded with the previous therapy
- Cirrhosis
- Not previously enrolled in any trial of Sofosbuvir
Exclusion Criteria:
- Not given informed consent
- Pregnancy
Age minimum:
17 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hepatitis C, Chronic
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Intervention(s)
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Drug: Sofosbuvir
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Primary Outcome(s)
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Sustained Viralogical response (SVR)
[Time Frame: 12 or 24 weeks after discontinuation of therapy]
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Secondary Outcome(s)
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Viral break through and relapse after discontinuation
[Time Frame: Time duration: Up to 12 or 24 weeks]
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Level of (Hepatitis C Virus) HCV RNA
[Time Frame: within 12 or 24 weeks from baseline]
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Secondary ID(s)
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PE/ZOVAL/2016/08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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