HCVPhase 3NCT05854511
Pharmacokinetics, Safety, Efficacy and Acceptability of Daclatasvir Plus Sofosbuvir in HCV-infected Children
A Phase 3 study testing Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tablets in people with HCV, run by Ain Shams University at 1 site in Egypt.
Trial summary
This is an interventional, single center, single arm clinical trial to assess the pharmacokinetics, safety, efficacy, and acceptability of daclatasvir plus sofosbuvir in treatment-naïve children weighing between 14 and 35 kg with chronic HCV GT 1-6 infection. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- HCV
- What is being tested?
- Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2022to 13 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children more than 3 years of age and weighing 14-35kg
- Infected with HCV genotypes 1-6
- Treatment Naïve HCV-infected children
- Signing a written consent form by the parent or the legal guardian, and -whenever applicable- an assent by the patient
- Screening laboratory values within predefined thresholds:
- Absolute neutrophil count ≥ 1,500/mm3
Show all 11Show fewer
- Platelets > 50,000 cells/mm3
- Albumin > 3.5 mg/dL
- Prothrombin Time PT < 4 sec above control Or International Normalized Ratio INR <1.7 3
- Random blood glucose level within normal range (> 70 mg/dL and < 200 mg/dL)
- Serum creatinine < 1.5 mg/dL
Who cannot join
- Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus
- Clinical hepatic decompensation, i.e., Child-Turcotte-Pugh CTP class B or C (i.e., jaundice, ascites, encephalopathy, or variceal hemorrhage)
- Renal dysfunction, i.e., eGFR < 60 mL/min/1.73 m2 or on regular dialysis as calculated by Schwartz Formula
- Alfa-fetoprotein level > 50 ng/mL
- Chronic liver disease due to a cause other than HCV or Known hypersensitivity to daclatasvir or sofosbuvir.
- History of gastrointestinal disease or gastrointestinal surgical procedure that would impair the absorption of the study drug
Show all 10Show fewer
- Blood/blood product transfusion within 4 weeks prior to study.
- Systemic corticosteroid administration for more than 2 weeks starting from two weeks before study inclusion and till the end of treatment period (pulmonary/nasal administration is permitted).
- Psychiatric hospitalization, suicide attempt or disability resulting from psychiatric illness within the prior 5 years.
- Ongoing treatment with any medications interacting with daclatasvir/sofosbuvir.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Ain-Shams University Research Institute-Clinical Research Centre (MASRI-CRC)
Cairo, 11591
Manal H. El-Sayed, MD, 002-01227461120, manalhelsayed@yahoo.co.uk
Manal H. El-Sayed, MD
About this study
Official title: Pharmacokinetics, Safety, Efficacy and Acceptability Study of Daclatasvir/Sofosbuvir in Children Weighing 14-35 Kilograms With Chronic Hepatitis C Virus Infection
This is an interventional, single center, single arm clinical trial to assess the pharmacokinetics, safety, efficacy, and acceptability of daclatasvir plus sofosbuvir in treatment-naïve children weighing between 14 and 35 kg with chronic HCV GT 1-6 infection.
Read the detailed description
This is an interventional, single center, single arm clinical trial to assess the pharmacokinetics, safety, efficacy, and acceptability of daclatasvir plus sofosbuvir in treatment-naïve, children weighing between 14 and 35 kg with chronic HCV GT 1-6 infection.
All enrolled patients will receive daclatasvir 30 mg orally once daily plus sofosbuvir at a dose of 200 mg (2x 100 mg tablets) orally once daily for 12 weeks.
Patients will be followed closely for disease progression and any hypersensitivity or adverse reactions due to therapy. Laboratory values to be monitored at baseline are serum creatinine, bilirubin, Aspartate transaminase (AST), Alanine transaminase (ALT), viral load (VL).
patients will be recruited in each of two weight bands (14 to < 17 kg and 17 to 35 kg). The study is mainly powered for non-compartmental pharmacokinetics determination of DCV, SOF and GS-331007. Patient recruitment will be done at Ain Shams university hospitals, Egypt. The study be will conducted after approval by the corresponding research ethical committee and obtaining an informed consent from the parents or the legal guardians, and -whenever applicable- an assent from the patients.
Total number of visits is 7 for patients who will complete the study, a screening visits, at the first day of therapy, at weeks 1, 4, 8, 12 and 24 after starting daclatasvir plus sofosbuvir. Patients who will complete their treatment schedule will come after 12 weeks for assessment of SVR. Duration of follow up will be 6 months from treatment initiation in addition to screening period (2-4 weeks).
- Conditions
- HCV
- Being tested
- Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tablets
- Keywords
- Daclatasvir, Sofosbuvir, Children, HCV, Pharmacokinetics, Safety, Efficacy, Acceptability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tabletsDrug
Also called Daklinza, Sovaldi
Daclatasvir 30 mg orally once daily plus Sofosbuvir at a dose of 200 mg (2x 100 mg tablets) orally once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Daclatasvir Plus Sofosbuvir | Experimental | treatment-naïve children infected with chronic HCV will be stratified according to weight
1. Children weighing 14 <17 Kg
2. Children weighting 17<35 Kg Receives: Drug: Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of Daclatasvir
The plasma concentration of Daclatasvir on day 8 will be used to derive the Pharmacokinetic parameters using the Non-Compartmental analysis (NCA)
Measured: one week
Plasma concentration of Sofosbuvir
The plasma concentration of Daclatasvir on day 8 will be used to derive the Pharmacokinetic parameters using the Non-Compartmental analysis (NCA)
Measured: one week
Secondary outcomes (2)
Efficacy of Daclatasvir 30 MG oral tablets and Sofosbuvir 200 MG oral tablets once daily for 12 weeks
Efficacy will be assessed via sustained virologic response at 12 weeks after the 12 weeks treatment completion (SVR12)
Measured: 24 weeks
Safety of Daclatasvir 30 MG oral tablets and Sofosbuvir 200 MG oral tablets once daily for 12 weeks
Safety o will be assessed by recording any adverse event occurs in treatment period and 2-4 weeks after the last visit (after week 24)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start5 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion13 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCVStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Manal Hamdy El-Sayed, Ain Shams University
- Investigators
- Manal H. El-Sayed, MD, Principal investigator, Department of Paediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854511
- Sponsor's protocol ID
- FMASU P04a / 2022
- Status last verified
- May 2023
- First submitted
- 21 Aug 2022
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Safety, Efficacy and Acceptability Study of Daclatasvir/Sofosbuvir in Children Weighing 14-35 Kilograms With Chronic Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT05854511
- Acronym / sponsor ID
- FMASU P04a / 2022
- Conditions
- HCV
- Keywords
- Daclatasvir, Sofosbuvir, Children, HCV, Pharmacokinetics, Safety, Efficacy, Acceptability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 13 Apr 2024 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an interventional, single center, single arm clinical trial to assess the pharmacokinetics, safety, efficacy, and acceptability of daclatasvir plus sofosbuvir in treatment-naïve children weighing between 14 and 35 kg with chronic HCV GT 1-6 infection.
Detailed description
This is an interventional, single center, single arm clinical trial to assess the pharmacokinetics, safety, efficacy, and acceptability of daclatasvir plus sofosbuvir in treatment-naïve, children weighing between 14 and 35 kg with chronic HCV GT 1-6 infection.
All enrolled patients will receive daclatasvir 30 mg orally once daily plus sofosbuvir at a dose of 200 mg (2x 100 mg tablets) orally once daily for 12 weeks.
Patients will be followed closely for disease progression and any hypersensitivity or adverse reactions due to therapy. Laboratory values to be monitored at baseline are serum creatinine, bilirubin, Aspartate transaminase (AST), Alanine transaminase (ALT), viral load (VL).
patients will be recruited in each of two weight bands (14 to < 17 kg and 17 to 35 kg). The study is mainly powered for non-compartmental pharmacokinetics determination of DCV, SOF and GS-331007. Patient recruitment will be done at Ain Shams university hospitals, Egypt. The study be will conducted after approval by the corresponding research ethical committee and obtaining an informed consent from the parents or the legal guardians, and -whenever applicable- an assent from the patients.
Total number of visits is 7 for patients who will complete the study, a screening visits, at the first day of therapy, at weeks 1, 4, 8, 12 and 24 after starting daclatasvir plus sofosbuvir. Patients who will complete their treatment schedule will come after 12 weeks for assessment of SVR. Duration of follow up will be 6 months from treatment initiation in addition to screening period (2-4 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daclatasvir Plus Sofosbuvir | Experimental | Drug: Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tabletstreatment-naïve children infected with chronic HCV will be stratified according to weight 1. Children weighing 14 <17 Kg 2. Children weighting 17<35 Kg |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Children more than 3 years of age and weighing 14-35kg
- Infected with HCV genotypes 1-6
- Treatment Naïve HCV-infected children
- Signing a written consent form by the parent or the legal guardian, and -whenever applicable- an assent by the patient
- Screening laboratory values within predefined thresholds:
Key exclusion criteria (10 listed)
- Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus
- Clinical hepatic decompensation, i.e., Child-Turcotte-Pugh CTP class B or C (i.e., jaundice, ascites, encephalopathy, or variceal hemorrhage)
- Renal dysfunction, i.e., eGFR < 60 mL/min/1.73 m2 or on regular dialysis as calculated by Schwartz Formula
- Alfa-fetoprotein level > 50 ng/mL
- Chronic liver disease due to a cause other than HCV or Known hypersensitivity to daclatasvir or sofosbuvir.
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 |
|---|---|---|
| Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tabletsAlso: Daklinza, SovaldiDaclatasvir 30 mg orally once daily plus Sofosbuvir at a dose of 200 mg (2x 100 mg tablets) orally once daily for 12 weeks. | Drug | Daclatasvir Plus Sofosbuvir |
Primary outcome
Plasma concentration of Daclatasvir
Time frame: one week
The plasma concentration of Daclatasvir on day 8 will be used to derive the Pharmacokinetic parameters using the Non-Compartmental analysis (NCA)
Plasma concentration of Sofosbuvir
Time frame: one week
The plasma concentration of Daclatasvir on day 8 will be used to derive the Pharmacokinetic parameters using the Non-Compartmental analysis (NCA)
2 secondary outcomes
Efficacy of Daclatasvir 30 MG oral tablets and Sofosbuvir 200 MG oral tablets once daily for 12 weeks
Time frame: 24 weeks
Safety of Daclatasvir 30 MG oral tablets and Sofosbuvir 200 MG oral tablets once daily for 12 weeks
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
Related trials for HCV
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
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.
Manal H. El-Sayed, MD principal investigator
Department of Paediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tablets in people with HCV, run by Ain Shams University at 1 site in Egypt.
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 11 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manal H. El-Sayed, MD (002-01227461120, manalhelsayed@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of Daclatasvir (time frame: one week). The study lists 2 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 11 May 2023.