Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03487848
Other study ID # AI444-423
Secondary ID 2017-003338-94
Status Terminated
Phase Phase 2
First received
Last updated
Start date June 25, 2018
Est. completion date September 17, 2020

Study information

Verified date April 2021
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date September 17, 2020
Est. primary completion date October 18, 2018
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility 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

Study Design


Intervention

Drug:
Daclatasvir
Specified dose on specified days for specified duration
Sofosbuvir
Specified dose on specified days for specified duration

Locations

Country Name City State
Australia Local Institution Melbourne Victoria
Spain Local Institution Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Australia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Primary Maximum Observed Plasma Concentration (Cmax) for Daclatasvir Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Primary Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Primary Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Primary Apparent Total Body Clearance (CLT/F) for Daclatasvir Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Secondary Number of Participants Experiencing Adverse Events This outcome describes the number of participants experiencing different types of any grade adverse events. From first dose to last dose (12 weeks)
Secondary Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis 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.
From the day after first dose to last dose (approximately 12 weeks)
Secondary Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis 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.
From day after last dose to end of follow-up period (up to approximately 96 weeks)
Secondary Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12 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)
12 weeks after last dose
See also
  Status Clinical Trial Phase
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Recruiting NCT04510246 - Link Hepatitis C Notifications to Treatment in Tasmania N/A
Completed NCT03413696 - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed NCT03109457 - Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
Completed NCT03118674 - Harvoni Treatment Porphyria Cutanea Tarda Phase 2
Completed NCT01458054 - Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults Phase 1
Completed NCT03740230 - An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
Completed NCT03426787 - Helping Empower Liver and Kidney Patients N/A
Completed NCT03627299 - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors Phase 4
Completed NCT00006301 - Immune Response to Hepatitis C Virus
Active, not recruiting NCT03949764 - The Kentucky Viral Hepatitis Treatment Study Phase 4
Completed NCT03365635 - Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C Phase 4
Recruiting NCT04405024 - Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients N/A
Completed NCT04525690 - Improving Inpatient Screening for Hepatitis C N/A
Completed NCT04033887 - Evaluation Study of RDTs Detecting Antibodies Against HCV
Withdrawn NCT04546802 - HepATocellular Cancer Hcv Therapy Study Phase 3
Active, not recruiting NCT02961426 - Strategic Transformation of the Market of HCV Treatments Phase 2/Phase 3
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Completed NCT02869776 - Integrating HCV and HIV Screening During the Era of HIV Antigen Testing N/A
Completed NCT03186313 - A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection Phase 3