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Trial record 7 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy

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ClinicalTrials.gov Identifier: NCT03903185
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Manal Hamdy El-Sayed, Ain Shams University

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Hematologic Malignancy Drug: Ledipasvir / Sofosbuvir Oral Product Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Active Comparator: HCV-infected patients with hematological malignancy
HCV-infected patients with hematological malignancy on maintenance chemotherapy
Drug: Ledipasvir / Sofosbuvir Oral Product
45 mg of ledipasvir and 200 mg of sofosbuvir orally, once daily with food
Other Name: LDV\SOF

Active Comparator: Control HCV-infected patients
Control HCV-infected patients without haematological malignancy or co-morbidities.
Drug: Ledipasvir / Sofosbuvir Oral Product
45 mg of ledipasvir and 200 mg of sofosbuvir orally, once daily with food
Other Name: LDV\SOF




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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) ]

    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.




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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;

    1. Decompensated liver disease as shown by the presence of ascites, encephalopathy, or a history of variceal hemorrhage.
    2. The ongoing treatment of other types of cancer or blood disorders.
    3. Co-infection with human immunodeficiency virus (HIV), or hepatitis B virus.
    4. Renal dysfunction.
    5. Active infection that is currently producing symptoms.

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): NCT03903185


Contacts
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Contact: Manal H ElSayed, MD 01227461120 manalhelsayed@yahoo.co.uk
Contact: Fatma S Ebeid, MD 01095569596 dr.fatma_ebeid@yahoo.com

Locations
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Egypt
Pediatric Department, Faculty of Medicine, Ain Shams University Recruiting
Cairo, Egypt, 11556
Contact: Manal H El-Sayed, MD    01227461120    manalhelsayed@yahoo.co.uk   
Contact: Fatma S Ebeid, MD    01095569596    dr.fatma_ebeid@yahoo.com   
Principal Investigator: Manal H ElSayed, MD         
Sub-Investigator: Aya M Abdel Magid, MSc         
Sub-Investigator: Maggie M Abbassi, PhD         
Sub-Investigator: Samar F Farid, PhD         
Sub-Investigator: Fatma S Ebeid, MD         
Sub-Investigator: Mohammed Hassany, MD         
Sponsors and Collaborators
Ain Shams University
Cairo University
Investigators
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Principal Investigator: Manal H Elsayed, MD Ain Shams University

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Responsible Party: Manal Hamdy El-Sayed, Professor of Pediatrics and Director of the Clinical Research Center, Ain Shams University
ClinicalTrials.gov Identifier: NCT03903185     History of Changes
Other Study ID Numbers: CL 3062
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Manal Hamdy El-Sayed, Ain Shams University:
Hepatitis C virus
Pharmacokinetic Modeling
Pharmacokinetics
Pediatrics
Leukemia
Ledipasvir
Sofosbuvir
Antiviral Drugs
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Hepatitis, Chronic
Sofosbuvir
Antiviral Agents
Anti-Infective Agents