Hepatitis CPhase 2NCT03487848
Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection
A Phase 2 study testing Daclatasvir and Sofosbuvir in people with Hepatitis C and Chronic Hepatitis, run by Bristol-Myers Squibb at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Hepatitis C, Chronic Hepatitis
- What is being tested?
- Daclatasvir and Sofosbuvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Jun 2018to 17 Sep 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection
- Conditions
- Hepatitis C, Chronic Hepatitis
- Being tested
- Daclatasvir, Sofosbuvir
- Medical subject headings
- Hepatitis C, Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaclatasvirDrug
Specified dose on specified days for specified duration
SofosbuvirDrug
Specified dose on specified days for specified duration
| Study group | Role | What they receive |
|---|---|---|
| Daclatasvir with Sofosbuvir | Experimental | Specified dose on specified days for specified duration Receives: Drug: Daclatasvir; Drug: Sofosbuvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Secondary outcomes (4)
Number of Participants Experiencing Adverse Events
This outcome describes the number of participants experiencing different types of any grade adverse events.
Measured: From first dose to last dose (12 weeks)
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.
Measured: From the day after first dose to last dose (approximately 12 weeks)
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.
Measured: From day after last dose to end of follow-up period (up to approximately 96 weeks)
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)
Measured: 12 weeks after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start25 Jun 2018
- Primary completion18 Oct 2018
- Study completion17 Sep 2020
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487848
- Sponsor's protocol ID
- AI444-423
- Other IDs
- 2017-003338-94, 2017
- Status last verified
- Apr 2021
- First submitted
- 20 Mar 2018
- Last updated
- 20 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03487848
- Acronym / sponsor ID
- AI444-423
- Conditions
- Hepatitis C, Chronic Hepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 4 Apr 2018 (actual)
- Results
- Posted 20 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daclatasvir with Sofosbuvir | Experimental | Drug: Daclatasvir, Drug: SofosbuvirSpecified dose on specified days for specified duration |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaclatasvirSpecified dose on specified days for specified duration | Drug | Daclatasvir with Sofosbuvir |
| SofosbuvirSpecified dose on specified days for specified duration | Drug | Daclatasvir with Sofosbuvir |
Primary outcome
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
4 secondary outcomes
Number of Participants Experiencing Adverse Events
Time frame: From first dose to last dose (12 weeks)
Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis
Time frame: From the day after first dose to last dose (approximately 12 weeks)
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)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daclatasvir and Sofosbuvir in people with Hepatitis C and Chronic Hepatitis, run by Bristol-Myers Squibb at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.