PK of SOF/LED in HCV - Infected Adolescents With Haematological Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-11

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents

NCT03343444

Hepatitis C Virus Infection, Response to Therapy of

UNKNOWN PHASE3

Treatment of Egyptian Hepatitis C Genotype 4 Infected Children and Adolescents With Combined Ledipasvir/Sofosbuvir

NCT03743727

Hepatitis C Genotype 4

UNKNOWN PHASE4

Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naïve Children

NCT05091008

Hepatitis C, Chronic

COMPLETED PHASE2

Pharmacokinetics of Sofosbuvir/Daclatasvir in HCV-infected Lactating Women

NCT04852614

Hepatitis C Virus Infection

UNKNOWN

Clinical Pharmacokinetics of Daclatasvir/Sofosbuvir in Adolescents With Hepatitis C Virus

NCT03540212

Chronic HCV Infection

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

HCV Infection Beta Thalassemia Major

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is a prospective, interventional, controlled, open-label, pharmacokinetic study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Beta thalassemia

HCV infected Beta thalassemia major adolescents

Group Type EXPERIMENTAL

Sofosbuvir and Ledipasvir

Intervention Type DRUG

fixed dose tablet containing 400 mg sofosbuvir and 90 mg ledipasvir

Control

HCV infected, otherwise healthy, sex and age matched to the thalassemia group serving as control group

Group Type ACTIVE_COMPARATOR

Sofosbuvir and Ledipasvir

Intervention Type DRUG

fixed dose tablet containing 400 mg sofosbuvir and 90 mg ledipasvir

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sofosbuvir and Ledipasvir

fixed dose tablet containing 400 mg sofosbuvir and 90 mg ledipasvir

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SOF/LED

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No