Hepatitis C, ChronicPhase 1/2NCT03903185
Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy
A Phase 1/2 study testing Ledipasvir / Sofosbuvir Oral Product in people with Hepatitis C, Chronic and Hematologic Malignancy, run by Ain Shams University at 2 sites in Egypt.
Trial summary
This is a prospective, controlled, open-label, pharmacokinetic study. This study aims at studying the PK of ledipasvir, sofosbuvir, and GS-331007 metabolite in HCV infected children with hematological malignancy. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Hepatitis C, Chronic, Hematologic Malignancy
- What is being tested?
- Ledipasvir / Sofosbuvir Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2019to 15 Aug 2023
- Phase
- Phase 1/2
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (6 to < 12 years of age and/or weighing 17.5 to < 35 Kg).
- Chronic HCV genotype 4 infection for at least 6 months without cirrhosis (confirmed by Fibroscan).
- Naïve patients to previous anti-HCV treatment.
- Diagnosed with hematological malignancy and on maintenance chemotherapy.
Who cannot join
- Known hypersensitivity to any of the study medications.
- Ongoing treatment with any interacting medications like carbamazepine, fosphenytoin, phenytoin, oxcarbazepine, phenobarbital, and rifampin.
- History of any comorbid illness that may interfere with the pharmacokinetics of the study drugs or prohibit the compliance with the study protocol such as;
- Decompensated liver disease as shown by the presence of ascites, encephalopathy, or a history of variceal hemorrhage.
- The ongoing treatment of other types of cancer or blood disorders.
- Co-infection with human immunodeficiency virus (HIV), or hepatitis B virus.
- Renal dysfunction.
- Active infection that is currently producing symptoms.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC)
Cairo, Cairo Governorate, 11566
Pediatric Hematology Oncology and BMT Department, Faculty of Medicine, Ain Shams University
Cairo, 11556
About this study
This is a prospective, controlled, open-label, pharmacokinetic study. This study aims at studying the PK of ledipasvir, sofosbuvir, and GS-331007 metabolite in HCV infected children with hematological malignancy.
In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir (LDV/SOF) orally, once daily with food.
Read the detailed description
In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir (LDV/SOF) orally, once daily with food, as prescribed by the attending physician.
Twelve eligible HCV-infected patients with hematological malignancy and 12 matching HCV control patients without haematological malignancy or co-morbidities will be enrolled in the study.
At baseline, careful history of the recruited patients including demographic characteristics (age, height, weight, and gender), comorbidities, medication history, familial history, social history, blood transfusion history, time on maintenance chemotherapy, and baseline laboratory tests will be documented. The baseline laboratory tests will include renal function tests (serum creatinine), liver function tests (bilirubin, albumin, AST, and ALT), international normalized ratio (INR), alpha fetoprotein (AFP), complete blood count (CBC), degree of liver fibrosis by Fibroscan, and viral load by PCR.
Followup will be done for all participants at baseline, after 12 weeks of treatment, and after 12 weeks from the end of treatment. A Forth visit will be done after 10 days of treatment for the evaluation of the steady state PK parameters of LDV\SOF in those patients.
- Conditions
- Hepatitis C, Chronic, Hematologic Malignancy
- Being tested
- Ledipasvir / Sofosbuvir Oral Product
- Keywords
- Hepatitis C virus, Pharmacokinetic Modeling, Pharmacokinetics, Pediatrics, Leukemia, Ledipasvir, Sofosbuvir, Antiviral Drugs
- Medical subject headings
- Hepatitis C, Chronic, Hematologic Neoplasms, Hepatitis C, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ledipasvir / Sofosbuvir Oral ProductDrug
Also called LDV\SOF
45 mg of ledipasvir and 200 mg of sofosbuvir orally, once daily with food
| Study group | Role | What they receive |
|---|---|---|
| HCV-infected patients with hematological malignancy | Active comparator | HCV-infected patients with hematological malignancy on maintenance chemotherapy Receives: Drug: Ledipasvir / Sofosbuvir Oral Product |
| Control HCV-infected patients | Active comparator | Control HCV-infected patients without haematological malignancy or co-morbidities. Receives: Drug: Ledipasvir / Sofosbuvir Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the pharmacokinetics of LDV\SOF
After 10 days of treatment, the steady state for LDV/SOF will be reached. Serial blood samples (2 mL/sample) will be collected at this time for the determination of LDV/SOF and GS-331007 concentrations from patients using an eight-point plasma schedule.
Blood sampling schedule will be as follows (Predose, 0.5,1, 2, 3, 4, 8, and 12h post dose; with predose also serving as t = 24).
Any deviations from nominal sampling times will be accurately recorded.
Measured: Blood samples will be collected after 10 days of treatment
Secondary outcomes (1)
Measurement of the number of participants with sustained virological response (SVR12), 12 weeks after discontinuation of therapy with ledipasvir-sofosbuvir (LDV-SOF).
Number of Participants with sustained virological response at 12 Weeks after end of study drug treatment (SVR12) will be recorded.
Participant will be considered to have achieved SVR12 if HCV RNA is less than the lower limit of quantification of <15 IU/ml) at 12 weeks after the end of treatment.
Measured: 12 weeks after discontinuation of therapy with ledipasvir-sofosbuvir (LDV\SOF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Mar 2019
- Primary completion1 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
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 Elsayed, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903185
- Sponsor's protocol ID
- CL 3062
- Status last verified
- Aug 2023
- First submitted
- 3 Apr 2019
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
AbdelMagid AM, Abbassi MM, Ebeid FS, El-Sayed MH, Farid SF. Population Pharmacokinetics of Ledipasvir/Sofosbuvir in Pediatric Patients: Impact of Acute Lymphoblastic Leukemia. Clin Ther. 2025 Feb;47(2):e5-e15. doi: 10.1016/j.clinthera.2024.11.022. Epub 2024 Dec 19.
PubMed 39706761AbdelMagid AM, Abbassi MM, Ebeid FS, Farid SF, El-Sayed MH. Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancies: A Pharmacokinetic Study. Clin Ther. 2024 Jan;46(1):e12-e22. doi: 10.1016/j.clinthera.2023.10.007. Epub 2023 Nov 3.
PubMed 37925363
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy
- ClinicalTrials.gov ID
- NCT03903185
- Acronym / sponsor ID
- CL 3062
- Conditions
- Hepatitis C, Chronic, Hematologic Malignancy
- Keywords
- Hepatitis C virus, Pharmacokinetic Modeling, Pharmacokinetics, Pediatrics, Leukemia, Ledipasvir, Sofosbuvir, Antiviral Drugs
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 4 Apr 2019 (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 a prospective, controlled, open-label, pharmacokinetic study. This study aims at studying the PK of ledipasvir, sofosbuvir, and GS-331007 metabolite in HCV infected children with hematological malignancy.
In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir (LDV/SOF) orally, once daily with food.
Detailed description
In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir (LDV/SOF) orally, once daily with food, as prescribed by the attending physician.
Twelve eligible HCV-infected patients with hematological malignancy and 12 matching HCV control patients without haematological malignancy or co-morbidities will be enrolled in the study.
At baseline, careful history of the recruited patients including demographic characteristics (age, height, weight, and gender), comorbidities, medication history, familial history, social history, blood transfusion history, time on maintenance chemotherapy, and baseline laboratory tests will be documented. The baseline laboratory tests will include renal function tests (serum creatinine), liver function tests (bilirubin, albumin, AST, and ALT), international normalized ratio (INR), alpha fetoprotein (AFP), complete blood count (CBC), degree of liver fibrosis by Fibroscan, and viral load by PCR.
Followup will be done for all participants at baseline, after 12 weeks of treatment, and after 12 weeks from the end of treatment. A Forth visit will be done after 10 days of treatment for the evaluation of the steady state PK parameters of LDV\SOF in those patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV-infected patients with hematological malignancy | Active comparator | Drug: Ledipasvir / Sofosbuvir Oral ProductHCV-infected patients with hematological malignancy on maintenance chemotherapy |
| Control HCV-infected patients | Active comparator | Drug: Ledipasvir / Sofosbuvir Oral ProductControl HCV-infected patients without haematological malignancy or co-morbidities. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children (6 to < 12 years of age and/or weighing 17.5 to < 35 Kg).
- Chronic HCV genotype 4 infection for at least 6 months without cirrhosis (confirmed by Fibroscan).
- Naïve patients to previous anti-HCV treatment.
- Diagnosed with hematological malignancy and on maintenance chemotherapy.
Key exclusion criteria (8 listed)
- Known hypersensitivity to any of the study medications.
- Ongoing treatment with any interacting medications like carbamazepine, fosphenytoin, phenytoin, oxcarbazepine, phenobarbital, and rifampin.
- History of any comorbid illness that may interfere with the pharmacokinetics of the study drugs or prohibit the compliance with the study protocol such as;
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 |
|---|---|---|
| Ledipasvir / Sofosbuvir Oral ProductAlso: LDV\SOF45 mg of ledipasvir and 200 mg of sofosbuvir orally, once daily with food | Drug | Control HCV-infected patients, HCV-infected patients with hematological malignancy |
Primary outcome
Measurement of the pharmacokinetics of LDV\SOF
Time frame: Blood samples will be collected after 10 days of treatment
After 10 days of treatment, the steady state for LDV/SOF will be reached. Serial blood samples (2 mL/sample) will be collected at this time for the determination of LDV/SOF and GS-331007 concentrations from patients using an eight-point plasma schedule. Blood sampling schedule will be as follows (Predose, 0.5,1, 2, 3, 4, 8, and 12h post dose; with predose also serving as t = 24). Any deviations from nominal sampling times will be accurately recorded.
1 secondary outcome
Measurement of the number of participants with sustained virological response (SVR12), 12 weeks after discontinuation of therapy with ledipasvir-sofosbuvir (LDV-SOF).
Time frame: 12 weeks after discontinuation of therapy with ledipasvir-sofosbuvir (LDV\SOF)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Derived from this study: PubMed 39706761AbdelMagid AM, Abbassi MM, Ebeid FS, El-Sayed MH, Farid SF. Population Pharmacokinetics of Ledipasvir/Sofosbuvir in Pediatric Patients: Impact of Acute Lymphoblastic Leukemia. Clin Ther. 2025 Feb;47(2):e5-e15. doi: 10.1016/j.clinthera.2024.11.022. Epub 2024 Dec 19.
- Derived from this study: PubMed 37925363AbdelMagid AM, Abbassi MM, Ebeid FS, Farid SF, El-Sayed MH. Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancies: A Pharmacokinetic Study. Clin Ther. 2024 Jan;46(1):e12-e22. doi: 10.1016/j.clinthera.2023.10.007. Epub 2023 Nov 3.
- Individual participant dataSharing planned: No
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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.
Manal H Elsayed, MD principal investigator
Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ledipasvir / Sofosbuvir Oral Product in people with Hepatitis C, Chronic and Hematologic Malignancy, run by Ain Shams University at 2 sites 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 22 Aug 2023. 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of the pharmacokinetics of LDV\SOF (time frame: Blood samples will be collected after 10 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03903185, which also lists 2 linked publications.
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 22 Aug 2023.