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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003338-94 | EudraCT Number |
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Business objectives have changed
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The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daclatasvir with Sofosbuvir | Experimental | Specified dose on specified days for specified duration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug | Specified dose on specified days for specified duration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Melbourne | Victoria | 3052 | Australia | ||
| Local Institution |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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5 participants were enrolled and treated
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| ID | Title | Description |
|---|---|---|
| FG000 | Daclatasvir (DCV) + Sofosbuvir (SOF) | DCV 60 mg QD + SOF 400 mg QD for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Daclatasvir (DCV) + Sofosbuvir (SOF) | DCV 60 mg QD + SOF 400 mg QD for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir | All treated participants | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose |
|
|
From first dose to 30 days following last dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daclatasvir (DCV) + Sofosbuvir (SOF) | DCV 60 mg QD + SOF 400 mg QD for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
This study was terminated early by sponsor for reasons unrelated to safety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2019 | Mar 12, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 24, 2019 | Mar 12, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006521 | Hepatitis, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C549273 | daclatasvir |
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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| Sofosbuvir |
| Drug |
Specified dose on specified days for specified duration |
|
Laboratory tests abnormalities were analyzed in the following categories:
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) |
| Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis | Laboratory tests abnormalities were analyzed in the following categories:
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) |
| 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 |
| Barcelona |
| 08950 |
| Spain |
| FDA Safety Alerts and Recalls | View source |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) for Daclatasvir | All treated participants | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 | All treated participants | Posted | Median | Full Range | Hours | 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 | All treated participants | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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 | All treated participants | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | 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. | All treated participants | Posted | Count of Participants | Participants | 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:
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. | All treated participants | Posted | Count of Participants | Participants | 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:
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. | All treated participants | Posted | Count of Participants | Participants | 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) | All treated participants | Posted | Number | 95% Confidence Interval | Percent of Participants | 12 weeks after last dose |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 4 |
| 5 |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
|