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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487848
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : December 24, 2019
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)
Estimated Enrollment : 30 participants
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 : May 18, 2018
Estimated Primary Completion Date : June 16, 2020
Estimated Study Completion Date : July 12, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Daclatasvir with Sofosbuvir Drug: Daclatasvir
Daily oral administration

Drug: Sofosbuvir
Daily oral administration




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 [ Time Frame: 120 weeks ]
  5. Number of participants with HCV RNA less than lower limit of quantification [ Time Frame: 24 weeks ]
  6. Number of participants with emergent NS5A resistance-associated variants derived from genotype [ Time Frame: 120 weeks ]
  7. Number of participants with emergent NS5B resistance-associated variants derived from genotype [ Time Frame: 120 weeks ]
  8. Responses from questionnaire assessing acceptability and palatability [ Time Frame: 12 weeks ]
    Utilizing the hedonic scale, a method for studying the participants acceptance of the DCV product



Information from the National Library of Medicine

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Ages Eligible for Study:   3 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

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


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Australia, Victoria
Local Institution Recruiting
Melbourne, Victoria, Australia, 3052
Contact: Site 0008         
Germany
Local Institution Recruiting
Wuppertal, Germany, 42283
Contact: Site 0005         
Poland
Local Institution Recruiting
Krakow, Poland, 31-202
Contact: Site 0007         
Local Institution Recruiting
Lodz, Poland, 91-347
Contact: Site 0006         
Romania
Local Institution Not yet recruiting
Bucuresti, Romania, 021105
Contact: Site 0001         
Spain
Local Institution Recruiting
Barcelona, Spain, 8950
Contact: Site 0003         
Local Institution Recruiting
Madrid, Spain, 28046
Contact: Site 0009         
Taiwan
Local Institution Recruiting
Taipei, Taiwan, 100
Contact: Site 0002         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03487848    
Other Study ID Numbers: AI444-423
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019

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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