Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection
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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
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Condition or disease | Intervention/treatment | Phase |
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Hepatitis C Chronic Hepatitis | Drug: Daclatasvir Drug: Sofosbuvir | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Daclatasvir with Sofosbuvir
Specified dose on specified days for specified duration
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Drug: Daclatasvir
Specified dose on specified days for specified duration Drug: Sofosbuvir Specified dose on specified days for specified duration |
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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.
- 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.
- 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.
- 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)

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

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
Australia, Victoria | |
Local Institution | |
Melbourne, Victoria, Australia, 3052 | |
Spain | |
Local Institution | |
Barcelona, Spain, 08950 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
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 |
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 |
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 |