Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Active, not recruiting
First Posted : April 4, 2018
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE March 20, 2018
First Posted Date  ICMJE April 4, 2018
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE May 18, 2018
Actual Primary Completion Date October 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2018)
  • Maximum observed concentration (Cmax) derived from plasma concentration for Daclatasvir [ Time Frame: 10 days ]
  • Time taken to reach maximum concentration (Tmax) derived from plasma concentration for Daclatasvir [ Time Frame: 10 days ]
  • Area under the concentration-time curve in one dosing interval [AUC(TAU)] derived from plasma concentration for Daclatasvir [ Time Frame: 10 days ]
  • Apparent total body clearance (CLT/F) derived from plasma concentration for Daclatasvir [ Time Frame: 10 days ]
  • Trough observed concentration (Cmin) derived from plasma concentration for Daclatasvir [ Time Frame: 10 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • Number of participants with adverse events (AEs) [ Time Frame: 16 weeks ]
  • Number of participants with serious adverse events (SAEs) [ Time Frame: 120 weeks ]
  • Number of participants with AEs leading to discontinuation of study therapy [ Time Frame: 12 weeks ]
  • Number of participants with laboratory abnormalities in blood [ Time Frame: 120 weeks ]
  • Number of participants with laboratory abnormalities in blood serum [ Time Frame: 120 weeks ]
  • Number of participants with HCV RNA less than lower limit of quantification [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2018)
  • Number of participants with adverse events (AEs) [ Time Frame: 16 weeks ]
    Up to post-treatment Week 4
  • Number of participants with serious adverse events (SAEs) [ Time Frame: 120 weeks ]
    Up to post-treatment week 108
  • Number of participants with AEs leading to discontinuation of study therapy [ Time Frame: 12 weeks ]
  • Number of participants with laboratory abnormalities [ Time Frame: 120 weeks ]
    Up to post-treatment week 108
  • Number of participants with HCV RNA less than lower limit of quantification [ Time Frame: 24 weeks ]
    Post-treatment week 12
  • Number of participants with emergent NS5A resistance-associated variants derived from genotype [ Time Frame: 120 weeks ]
    Up to post-treatment week 108
  • Number of participants with emergent NS5B resistance-associated variants derived from genotype [ Time Frame: 120 weeks ]
    Up to post-treatment week 108
  • Responses from questionnaire assessing acceptability and palatability [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis C
  • Chronic Hepatitis
Intervention  ICMJE
  • Drug: Daclatasvir
    Specified dose on specified days for specified duration
  • Drug: Sofosbuvir
    Specified dose on specified days for specified duration
Study Arms  ICMJE Experimental: Daclatasvir with Sofosbuvir
Specified dose on specified days for specified duration
Interventions:
  • Drug: Daclatasvir
  • Drug: Sofosbuvir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 14, 2020)
5
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2018)
30
Estimated Study Completion Date  ICMJE June 1, 2020
Actual Primary Completion Date October 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   Poland,   Romania,   Spain,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03487848
Other Study ID Numbers  ICMJE AI444-423
2017-003338-94 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP