Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection
NCT ID: NCT03487848
Last Updated: 2021-04-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2018-06-25
2020-09-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Daclatasvir with Sofosbuvir
Specified dose on specified days for specified duration
Daclatasvir
Specified dose on specified days for specified duration
Sofosbuvir
Specified dose on specified days for specified duration
Interventions
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Daclatasvir
Specified dose on specified days for specified duration
Sofosbuvir
Specified dose on specified days for specified duration
Eligibility Criteria
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Inclusion Criteria
* HCV RNA ≥1,000 IU/mL at Screening
* Participants who are HCV-treatment naïve or treatment experienced
* Participants in Cohort 1 must have a body weight ≥ 45kg at Day 1
Exclusion Criteria
* Evidence of an ongoing medical condition contributing to chronic liver disease other than HCV
* Evidence of cirrhosis, either compensated or decompensated
* Prior exposure to sofosbuvir and/or NS5A inhibitor
12 Years
17 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Melbourne, Victoria, Australia
Local Institution
Barcelona, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2017-003338-94
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI444-423
Identifier Type: -
Identifier Source: org_study_id
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