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

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ClinicalTrials.gov Identifier: NCT04353986
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Manal Hamdy El-Sayed, Ain Shams University

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
HCV Infection Beta Thalassemia Major Drug: Sofosbuvir and Ledipasvir Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective, interventional, controlled, open-label, pharmacokinetic study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Sofosbuvir and Ledipasvir in Hepatitis C Virus - Infected Adolescent Patients With Haematological Disorders
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Beta thalassemia
HCV infected Beta thalassemia major adolescents
 Drug: Sofosbuvir and Ledipasvir
fixed dose tablet containing 400 mg sofosbuvir and 90 mg ledipasvir
Other Name: SOF/LED
Active Comparator: Control
HCV infected, otherwise healthy, sex and age matched to the thalassemia group serving as control group
 Drug: Sofosbuvir and Ledipasvir
fixed dose tablet containing 400 mg sofosbuvir and 90 mg ledipasvir
Other Name: SOF/LED


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. sustained virologic response [ Time Frame: 6 months ]
    sustained virologic response


Secondary Outcome Measures :
  1. adverse drug reactions [ Time Frame: 3 months ]
    record any adverse drug reactions experienced by the patients


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353986


Contacts
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Contact: Manal H El-Sayed, M.D. 01227461120 ext 002 manalhelsayed@yahoo.co.uk
Contact: Fatma S Ebeid, M.D. 01095569596 ext 002 dr.fatma_ebeid@yahoo.com

Locations
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Egypt
Masri-Crc Recruiting
Cairo, Egypt
Contact: Manal H El-Sayed, M.D.    01227461120 ext 002    manalhelsayed@yahoo.co.uk   
Contact: Fatma S Ebeid, M.D.    01095569596 ext 002    dr.fatma_ebeid@yahoo.com   
Sub-Investigator: Eman A El-Baraky, Ms.C.         
Sub-Investigator: Nirmeen A Sabry, Ph.D.         
Principal Investigator: Maggie M Abbassi, Ph.D         
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Manal H El-Sayed, M.D Director of MARSI-CRC
More Information
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Responsible Party: Manal Hamdy El-Sayed, Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT04353986    
Other Study ID Numbers: CL30114
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manal Hamdy El-Sayed, Ain Shams University:
Hepatitis C virus
Pharmacokinetic Modeling
Pharmacokinetics
Sofosbuvir
 Ledipasvir
Direct acting antivirals
Beta thalassemia major
Additional relevant MeSH terms:
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Hepatitis C
Thalassemia
beta-Thalassemia
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hemoglobinopathies
Genetic Diseases, Inborn
Hepatitis, Viral, Human
Virus Diseases
 Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Sofosbuvir
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Antiviral Agents
Anti-Infective Agents