A Phase 2 interventional study of Daclatasvir and Sofosbuvir in Hepatitis C and Chronic Hepatitis, sponsored by Bristol-Myers Squibb. Terminated at 2 sites in 2 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-04-20.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection
1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.
This study's enrollment of 5 is below the median of 72 across 1,223 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Specified dose on specified days for specified duration
Drug: Daclatasvir · Drug: Sofosbuvir
Specified dose on specified days for specified duration
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
This outcome describes the number of participants experiencing different types of any grade adverse events.
Time frame: 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.
Time frame: 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.
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
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)
Time frame: 12 weeks after last dose
| Milestone | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| Started | 5 |
| Completed | 4 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
| ng/mL | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir | 152.94 ± 48.3 |
| ng/mL | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) for Daclatasvir | 1215.32 ± 37.2 |
| Hours | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir | 2.00 (1.0 to 4.0) |
| h*ng/mL | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir | 11535.45 ± 26.6 |
| mL/min | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| Apparent Total Body Clearance (CLT/F) for Daclatasvir | 86.69 ± 22.3 |
This outcome describes the number of participants experiencing different types of any grade adverse events.
| Participants | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| Adverse Events (AEs) | 4 |
| Serious Adverse Events (SAEs) | 0 |
| AEs leading to discontinuation | 0 |
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.
| Participants | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis | 1 |
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.
| Participants | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis | 2 |
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)
| Percent of Participants | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12 | 100 (50 to 100) |
Collected over From first dose to 30 days following last dose. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Daclatasvir (DCV) + Sofosbuvir (SOF) | 0/5 (0%) | 0/5 (0%) | 4/5 (80%) |
| Event | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| HeadacheNervous system disorders | 2/5 |
| Abdominal painGastrointestinal disorders | 1/5 |
| PyrexiaGeneral disorders | 1/5 |
| Seasonal allergyImmune system disorders | 1/5 |
| NasopharyngitisInfections and infestations | 1/5 |
| RhinitisInfections and infestations | 1/5 |
| Upper respiratory tract infectionInfections and infestations | 1/5 |
| Limb injuryInjury, poisoning and procedural complications | 1/5 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 1/5 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/5 |
| Age, Continuous(Years) | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| Mean | 13.6 ± 1.3 |
| Sex: Female, Male(Participants) | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| Female | 2 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 5 |
| Race/Ethnicity, Customized(Participants) | Daclatasvir (DCV) + Sofosbuvir (SOF) |
|---|---|
| White | 4 |
| Other | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2018 to primary completion in Oct 2018, 3 months.
Results were first posted in Apr 2021, 2 years 6 months after primary completion.
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This study is terminated, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Daclatasvir · Sofosbuvir