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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 : Terminated (Business objectives have changed)
First Posted : April 4, 2018
Results First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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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 : June 25, 2018
Actual Primary Completion Date : October 18, 2018
Actual Study Completion Date : September 17, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir [ Time Frame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose ]
  2. Maximum Observed Plasma Concentration (Cmax) for Daclatasvir [ Time Frame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose ]
  3. Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir [ Time Frame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose ]
  4. Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir [ Time Frame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose ]
  5. Apparent Total Body Clearance (CLT/F) for Daclatasvir [ Time Frame: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose ]

Secondary Outcome Measures :
  1. Number of Participants Experiencing Adverse Events [ Time Frame: From first dose to last dose (12 weeks) ]
    This outcome describes the number of participants experiencing different types of any grade adverse events.

  2. Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis [ Time Frame: From the day after first dose to last dose (approximately 12 weeks) ]

    Laboratory tests abnormalities were analyzed in the following categories:

    • Hematology (hemoglobin, platelets, international normalized ratio (INR), white blood cell count (WBC), lymphocytes (absolute), neutrophils + bands (absolute; ANC)).
    • Hepatobiliary enzymes (ALT, AST, alkaline phosphatase, total bilirubin, albumin).
    • Pancreatic enzymes (lipase, creatinine). Tests results were reported by worst toxicity grade (0 to 4) based on the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (2017).

    Only laboratory abnormalities with a worst toxicity grade 3 or higher in any of the above-mentioned tests, experienced during the on-treatment period, are reported here.


  3. Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis [ Time Frame: From day after last dose to end of follow-up period (up to approximately 96 weeks) ]

    Laboratory tests abnormalities were analyzed in the following categories:

    • Hematology (hemoglobin, platelets, international normalized ratio (INR), white blood cell count (WBC), lymphocytes (absolute), neutrophils + bands (absolute; ANC)).
    • Hepatobiliary enzymes (ALT, AST, alkaline phosphatase, total bilirubin, albumin).
    • Pancreatic enzymes (lipase, creatinine). Tests results were reported by worst toxicity grade (0 to 4) based on the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (2017).

    Only laboratory abnormalities with a worst toxicity grade 3 or higher in any of the above-mentioned tests, experienced during the follow-up period, are reported here.


  4. Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12 [ Time Frame: 12 weeks after last dose ]

    HCV RNA levels were measured by using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test v2.0. This assay has a lower limit of quantitation (LLOQ) = 15 IU/mL.

    The outcome includes both results where Target was Detected (TD) but below LLOQ and results were Target was Not Detected (TND)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


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
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] December 18, 2019
Statistical Analysis Plan  [PDF] December 24, 2019

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
Results First Posted: April 20, 2021
Last Update Posted: April 20, 2021
Last Verified: April 2021

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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
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents