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Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487848
Recruitment Status : Completed
First Posted : April 4, 2018
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection

Condition or disease Intervention/treatment Phase
Hepatitis C Chronic Hepatitis Drug: Daclatasvir Drug: Sofosbuvir Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children From 3 to Less Than 18 Years of Age With GT-1 to -6 Chronic Hepatitis C (CHC) Infection
Actual Study Start Date : July 17, 2018
Actual Primary Completion Date : October 18, 2018
Actual Study Completion Date : September 17, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Daclatasvir with Sofosbuvir
Specified dose on specified days for specified duration
 Drug: Daclatasvir
Specified dose on specified days for specified duration

Drug: Sofosbuvir
Specified dose on specified days for specified duration


Outcome Measures
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Primary Outcome Measures :
  1. Maximum observed concentration (Cmax) derived from plasma concentration for Daclatasvir [ Time Frame: 10 days ]
  2. Time taken to reach maximum concentration (Tmax) derived from plasma concentration for Daclatasvir [ Time Frame: 10 days ]
  3. Area under the concentration-time curve in one dosing interval [AUC(TAU)] derived from plasma concentration for Daclatasvir [ Time Frame: 10 days ]
  4. Apparent total body clearance (CLT/F) derived from plasma concentration for Daclatasvir [ Time Frame: 10 days ]
  5. Trough observed concentration (Cmin) derived from plasma concentration for Daclatasvir [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: 16 weeks ]
  2. Number of participants with serious adverse events (SAEs) [ Time Frame: 120 weeks ]
  3. Number of participants with AEs leading to discontinuation of study therapy [ Time Frame: 12 weeks ]
  4. Number of participants with laboratory abnormalities in blood [ Time Frame: 120 weeks ]
  5. Number of participants with laboratory abnormalities in blood serum [ Time Frame: 120 weeks ]
  6. Number of participants with HCV RNA less than lower limit of quantification [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Participants monoinfected with HCV genotype -1 to -6
  • 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:

  • Mixed genotype HCV infections
  • 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

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487848


Locations
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Australia, Victoria
Local Institution
Melbourne, Victoria, Australia, 3052
Spain
Local Institution
Barcelona, Spain, 08950
Local Institution
Madrid, Spain, 28046
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03487848    
Other Study ID Numbers: AI444-423
2017-003338-94 ( EudraCT Number )
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents