HCV InfectionPhase 3NCT04353986
PK of SOF/LED in HCV - Infected Adolescents With Haematological Disorders
A Phase 3 study testing Sofosbuvir and Ledipasvir in people with HCV Infection and Beta Thalassemia Major, run by Ain Shams University at 1 site in Egypt.
Trial summary
This is a prospective, controlled, open-label, pharmacokinetic study. This study aims at studying the PK of sofosbuvir, ledipasvir and sofosbuvir metabolite (GS-331007) in HCV infected children with hematological Disorders. to develop predictive pharmacokinetic model for the 3 moieties in the studied population. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- HCV Infection, Beta Thalassemia Major
- What is being tested?
- Sofosbuvir and Ledipasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jun 2018to Dec 2023
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents (ages 12-18 years) and/ or weight more than 35 Kg
- Diagnosed with beta-thalassemia major and receiving regular blood transfusion
- spleenectomised
- Chronic HCV infection (defined as more than 6 months history of the disease)
- Naïve non-cirrhotic population with FIB Score: F0 to F3 as measured by Fibroscan
- Screening laboratory values of the beta-thalassemia group within the following thresholds (absolute neutrophil count > 1500/mm3, platelets > 7500 cells/mm3 , Serum creatinine < 1.2 mg/dl, creatinine clearance > 40 mL/min, albumin >3.5 gm/dl, and aspartate transaminase (AST) and alanine transaminase (ALT) level less than 5 fold of the normal limit). Control group should have normal biochemical profile.
- Assent of the patients and consent of their legal guardians are required
Who cannot join
- Previous treatment for HCV.
- History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol or affect the pharmacokinetics of the study drugs. Such as,
- Ongoing or untreated cancer including haematologic and hepatic cancers
- Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus or hepatitis B virus
- Clincal hepatic decompensation (i.e., ascites, encephalopathy or variceal haemorrhage)
- Renal dysfunction
Show all 9Show fewer
- Active infection (any infection showing clinical manifestation at time of sampling)
- Known hypersensitivity to study medications
- Ongoing treatment with cyclosporine, rifampin, phenytoin, carbamazepine, phenobarbital, or amiodarone.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Masri-Crc
Cairo
Manal H El-Sayed, M.D., 01227461120 ext. 002, manalhelsayed@yahoo.co.uk
Fatma S Ebeid, M.D., 01095569596 ext. 002, dr.fatma_ebeid@yahoo.com
About this study
Official title: Pharmacokinetics of Sofosbuvir and Ledipasvir in Hepatitis C Virus - Infected Adolescent Patients With Haematological Disorders
This is a prospective, controlled, open-label, pharmacokinetic study. This study aims at studying the PK of sofosbuvir, ledipasvir and sofosbuvir metabolite (GS-331007) in HCV infected children with hematological Disorders. to develop predictive pharmacokinetic model for the 3 moieties in the studied population.
In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 400 mg of sofosbuvir and 90 mg of ledipasvir(SOF/LED) 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 400 mg of sofosbuvir and 90 mg of ledipasvir(SOF/LED) orally, once daily with food, as prescribed by the attending physician. Twelve eligible HCV-infected patients with hematological disorder and 12 matching HCV control patients without haematological disorder or comorbidities 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, 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 normalised ratio (INR), alpha fetoprotein (AFP), complete blood count (CBC), degree of liver fibrosis by Fibroscan,viral load by PCR and HCV genotype Follow-up will be done for all participants at baseline, after 10 days of treatment for the evaluation of the steady state PK parameters of SOF/LED in those patients, after 12 weeks of treatment, and after 12 weeks from the end of treatment. For a total of 4 follow-up visits.
- Conditions
- HCV Infection, Beta Thalassemia Major
- Being tested
- Sofosbuvir and Ledipasvir
- Keywords
- Hepatitis C virus, Pharmacokinetic Modeling, Pharmacokinetics, Sofosbuvir, Ledipasvir, Direct acting antivirals, Beta thalassemia major
- Medical subject headings
- Hepatitis C, beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir and LedipasvirDrug
Also called SOF/LED
fixed dose tablet containing 400 mg sofosbuvir and 90 mg ledipasvir
| Study group | Role | What they receive |
|---|---|---|
| Beta thalassemia | Experimental | HCV infected Beta thalassemia major adolescents Receives: Drug: Sofosbuvir and Ledipasvir |
| Control | Active comparator | HCV infected, otherwise healthy, sex and age matched to the thalassemia group serving as control group Receives: Drug: Sofosbuvir and Ledipasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Pharmacokinetic Model
serial blood samples will be withdrawn to measure the drug level develop a Predictive Pharmacokinetic Model for sofosbuvir, ledipasvir and GS 331007
Measured: 10 days
sustained virologic response
sustained virologic response
Measured: 6 months
Secondary outcomes (1)
adverse drug reactions
record any adverse drug reactions experienced by the patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start11 Jun 2018
- Primary completionApr 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCV InfectionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, interventional, controlled, open-label, pharmacokinetic study.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Hamdy El-Sayed, Ain Shams University
- Investigators
- Manal H El-Sayed, M.D, Principal investigator, Director of MARSI-CRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353986
- Sponsor's protocol ID
- CL30114
- Status last verified
- Mar 2023
- First submitted
- 15 Jul 2019
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Baraky IA, Abbassi MM, Ebeid FS, Hassany M, Sabry NA, El-Sayed MH. Beta-thalassemia major alters sofosbuvir/ledipasvir exposure in Hepatitis C virus infected adolescent patients. Clin Res Hepatol Gastroenterol. 2021 Sep;45(5):101747. doi: 10.1016/j.clinre.2021.101747. Epub 2021 Jun 26.
PubMed 34186262
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Sofosbuvir and Ledipasvir in Hepatitis C Virus - Infected Adolescent Patients With Haematological Disorders
- ClinicalTrials.gov ID
- NCT04353986
- Acronym / sponsor ID
- CL30114
- Conditions
- HCV Infection, Beta Thalassemia Major
- Keywords
- Hepatitis C virus, Pharmacokinetic Modeling, Pharmacokinetics, Sofosbuvir, Ledipasvir, Direct acting antivirals, Beta thalassemia major
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Apr 2020 (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 sofosbuvir, ledipasvir and sofosbuvir metabolite (GS-331007) in HCV infected children with hematological Disorders. to develop predictive pharmacokinetic model for the 3 moieties in the studied population.
In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 400 mg of sofosbuvir and 90 mg of ledipasvir(SOF/LED) 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 400 mg of sofosbuvir and 90 mg of ledipasvir(SOF/LED) orally, once daily with food, as prescribed by the attending physician. Twelve eligible HCV-infected patients with hematological disorder and 12 matching HCV control patients without haematological disorder or comorbidities 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, 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 normalised ratio (INR), alpha fetoprotein (AFP), complete blood count (CBC), degree of liver fibrosis by Fibroscan,viral load by PCR and HCV genotype Follow-up will be done for all participants at baseline, after 10 days of treatment for the evaluation of the steady state PK parameters of SOF/LED in those patients, after 12 weeks of treatment, and after 12 weeks from the end of treatment. For a total of 4 follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, interventional, controlled, open-label, pharmacokinetic study.
| Arm | Type | Receives |
|---|---|---|
| Beta thalassemia | Experimental | Drug: Sofosbuvir and LedipasvirHCV infected Beta thalassemia major adolescents |
| Control | Active comparator | Drug: Sofosbuvir and LedipasvirHCV infected, otherwise healthy, sex and age matched to the thalassemia group serving as control group |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Adolescents (ages 12-18 years) and/ or weight more than 35 Kg
- Diagnosed with beta-thalassemia major and receiving regular blood transfusion
- spleenectomised
- Chronic HCV infection (defined as more than 6 months history of the disease)
- Naïve non-cirrhotic population with FIB Score: F0 to F3 as measured by Fibroscan
Key exclusion criteria (9 listed)
- Previous treatment for HCV.
- History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol or affect the pharmacokinetics of the study drugs. Such as,
- Known hypersensitivity to study medications
- Ongoing treatment with cyclosporine, rifampin, phenytoin, carbamazepine, phenobarbital, or amiodarone.
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 and LedipasvirAlso: SOF/LEDfixed dose tablet containing 400 mg sofosbuvir and 90 mg ledipasvir | Drug | Beta thalassemia, Control |
Primary outcome
Predictive Pharmacokinetic Model
Time frame: 10 days
serial blood samples will be withdrawn to measure the drug level develop a Predictive Pharmacokinetic Model for sofosbuvir, ledipasvir and GS 331007
sustained virologic response
Time frame: 6 months
sustained virologic response
1 secondary outcome
adverse drug reactions
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Derived from this study: PubMed 34186262El-Baraky IA, Abbassi MM, Ebeid FS, Hassany M, Sabry NA, El-Sayed MH. Beta-thalassemia major alters sofosbuvir/ledipasvir exposure in Hepatitis C virus infected adolescent patients. Clin Res Hepatol Gastroenterol. 2021 Sep;45(5):101747. doi: 10.1016/j.clinre.2021.101747. Epub 2021 Jun 26.
- 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 El-Sayed, M.D principal investigator
Director of MARSI-CRC
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 and Ledipasvir in people with HCV Infection and Beta Thalassemia Major, 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 7 inclusion and 9 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 6 Mar 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, M.D. (01227461120 ext. 002, manalhelsayed@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Pharmacokinetic Model (time frame: 10 days). 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?
On the ClinicalTrials.gov record for NCT04353986, which also lists 1 linked publication.
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 6 Mar 2023.