Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 70 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Eight Weeks Sofosbovir/Ledipasvir in HCV Infected Children Aged 4 to 10 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03764345
Recruitment Status : Completed
First Posted : December 5, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Mostafa M. Sira, National Liver Institute, Egypt

Brief Summary:
Recently the era of direct-acting antiviral drugs for hepatitis C treatment has changed the world map of HCV. Results in adults are promising. FDA approved only two drugs in the pediatric age group 12 to 17 years. Younger children are still on the wait list for treatment. The current study aimed to treat children aged between 3 and 12 years with half the adult dose of Sofosbuvir/Ledipasvir combination (Heterosofir).

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Children, Only Drug: Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir) Not Applicable

Detailed Description:

The WHO has declared hepatitis C a global health problem, with ∼ 3% of the world's population (roughly 170-200 million individuals) infected with HCV. Egypt has the highest prevalence of HCV in the world, ranging from 6 to 28%, with an average of ∼ 13.8% in the general population. Ap-proximately 90% of Egyptian HCV isolates belong to a single subtype, 4a.

Hepatitis C virus (HCV) is a major cause of chronic liver disease and a prin-cipal reason for liver transplant; approximately 170 million people worldwide are chronically infected. There is general consensus that HCV elimination is associated with strong and sustained CD4+ and CD8+ T cell res-ponses that target multiple epitopes within the different HCV proteins, however, they are not maintained in patients who develop chronic disease . A variety of factors purportedly contribute to the dimi-nished T cell responses observed in chronically infected patients, including an im-paired dendritic cell (DC) function.

The successful development of direct-acting antivirals (DAAs) that are active against hepatitis C virus has transformed chronic hepatitis C infection from a con-dition requiring complex therapies with unsatisfactory outcomes to one that can be easily treated with few contraindications and side-effects. Since 2011, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved eight oral DAA regimens for the treatment of adults with chronic hepatitis C. Investigation into DAAs for children has been slower.

For adolescents aged 12-17 years, the safety and efficacy of the fixed-dose combination sofosbuvir and ledipasvir for genotype 1 or 4 infection and of combination sofosbuvir plus ribavirin for genotype 2 or 3 infection have been described in full-length articles.

A recent study explored the safety and efficacy of combination sofosbuvirplus ribavirin in Pakistani children (aged 5-18 years) with hepatitis C virus genotype 1, 2, or 3 infection. Further results have been presented as ab-stracts for the fixed-dose combination sofosbuvir and ledipasvir in children aged 6-11 years for the fixed-dose combination ombitasvir, pari-taprevir, and ritonavir with or without dasabuvir and with or without ribavirin in adolescents aged 12-17 years with genotype 1 or 4 infection and for combination sofosbuvir plus daclatasvir with or without ribavirin in Egyp-tian adolescents aged 12-17 years with genotype 4 infection.

Dendritic cells are professional antigen presenting cells characterized by a po-tent capacity to elicit primary T cell responses. Two major subsets of DC can be identified from human peripheral blood: plasmacytoid (p) DC and conventional or myeloid (m) DC. Each subset represents 0.3-0.5% of the normal human peripheral blood mononuclear cell (PBMC) population.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sofosbovir/Ledipasvir in HCV Infected Children Aged From 4 to 10 Years
Actual Study Start Date : December 6, 2018
Actual Primary Completion Date : July 2, 2019
Actual Study Completion Date : July 2, 2019

Arm Intervention/treatment
Experimental: Sofosbovir/Ledipasvir Daily
Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks
Drug: Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)
Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks




Primary Outcome Measures :
  1. Side effect 1 Number of patients with fatigue [ Time Frame: 8 weeks ]
    Number of patients with fatigue

  2. Side effect 2 Number of patients with Headache [ Time Frame: 8 weeks ]
    Number of patients with Headache

  3. Side effect 3 Number of patients with nausea [ Time Frame: 8 weeks ]
    Number of patients with nausea

  4. Side effect 4 Number of patients with diarrhea [ Time Frame: 8 weeks ]
    Number of patients with diarrhea

  5. Side effect 5 Number of patients with insomnia [ Time Frame: 8 weeks ]
    Number of patients with insomnia

  6. Side effect 6 Number of patients with weakness [ Time Frame: 8 weeks ]
    Number of patients with weakness

  7. Side effect 7 Number of patients with bradycardia [ Time Frame: 8 weeks ]
    Number of patients with bradycardia

  8. Side effect 8 Number of patients with cough [ Time Frame: 8 weeks ]
    Number of patients with cough

  9. Side effect 9 Number of patients with myalgia [ Time Frame: 8 weeks ]
    Number of patients with myalgia

  10. Side effect 10 Number of patients with dysapnea [ Time Frame: 8 weeks ]
    Number of patients with dysapnea

  11. Side effect 11 Number of patients with irritability [ Time Frame: 8 weeks ]
    Number of patients with irritability

  12. Side effect 12 Number of patients with dizziness [ Time Frame: 8 weeks ]
    Number of patients with dizziness

  13. Side effect 13 Number of patients with depression [ Time Frame: 8 weeks ]
    Number of patients with depression

  14. Side effect 14 Number of patients with skin rash [ Time Frame: 8 weeks ]
    Number of patients with skin rash


Secondary Outcome Measures :
  1. HCV-RNA PCR by the end of therapy [ Time Frame: 8 weeks ]
    HCV-RNA PCR at week 8

  2. HCV-RNA PCR after 20 weeks for SVR [ Time Frame: 20 weeks ]
    HCV-RNA PCR at week 20


Other Outcome Measures:
  1. Treatment safety-1 Alanine transaminase serum level [ Time Frame: 8 weeks ]
    Alanine transaminase serum level

  2. Treatment safety-2 Aspartate transaminase serum level [ Time Frame: 8 weeks ]
    Aspartate transaminase serum level

  3. Treatment safety-2 Degree of liver fibrosis [ Time Frame: 8 weeks ]
    Liver Stiffness measurement before and after end of therapy

  4. Treatment tolerability-1 Patient height [ Time Frame: 20 weeks ]
    measurement of Height

  5. Treatment tolerability-2 Body weight [ Time Frame: 20 weeks ]
    measurement of weight



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with chronic HCV
  • age 3- 12 y old
  • weight 17- 35kg
  • Basal HCV viremia less than 6.8 log IU/mL
  • Treatment-naive
  • No cirrhosis

Exclusion Criteria:

  • Patients with dual HBV and HCV infection or associated with chronic hepatitis other than chronic HCV
  • age below 3 years or above 12 years
  • body weight less than 17 or more than 35 Kg
  • HCV/HIV coinfection.
  • Patients with HCV infection and HCC.
  • Patients with HCV infection and underlying cardiac comorbidities
  • Decompensated patients with HCV
  • Hypoalbuminemia of < 3.5g/dL.
  • International normalised ratio (INR) >2.
  • Advanced fibrosis scoring by transient elastography (F 4 broScan)
  • Any concomitant malignancy.
  • Parents' refusal for participation of their children in the study.

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): NCT03764345


Locations
Layout table for location information
Egypt
Pediatric Hepatology, Gastroenterology and Nutrition Department, National Liver Institute, Menoufia University
Shebin El-Koom, Menofiya, Egypt, 32511
Sponsors and Collaborators
National Liver Institute, Egypt
Investigators
Layout table for investigator information
Principal Investigator: Behairy E Behairy, Prof National Liver Institute, Menoufia University
Study Director: Hanaa A El-Araby, Prof National Liver Institute, Menoufia University
Study Director: Mohamed A El-Guindi, Prof National Liver Institute, Menoufia University
Study Chair: Hosam M Basiouny, MD National Liver Institute, Menoufia University
Study Chair: Ola A Fouad, MD National Liver Institute, Menoufia University
Study Chair: Ayman M Marey, Prof Faculty of Medicine, Zagazig University
Study Chair: Bassam A Ayoub, MD National Liver Institute, Menoufia University

Publications:
El-Sayed M, Hassany M, Asem N. A pilot study for safety and efficacy of 12 weeks sofosbuvir plus daclatasvir with or without ribavirin in Egyptian adoles-cents with chronic hepatitis C virus Infection. Journal of Hepatology 2017,66:S178
Murray KF, Balistreri W, Bansal S, Whitworth S, Evans H, Gonzalez-Peralta R, et al. Ledipasvir/sofosbuvir±ribavirin for 12 or 24 weeks is safe and effective in children 6-11 years old with chronic hepatitis C infection. Journal of Hepatology 2017,66:S57-S58

Layout table for additonal information
Responsible Party: Mostafa M. Sira, Assistant Professor, National Liver Institute, Egypt
ClinicalTrials.gov Identifier: NCT03764345     History of Changes
Other Study ID Numbers: Sof-Led-HCV-Ped
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Virus Diseases
RNA Virus Infections
Ledipasvir
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Hepatitis, Chronic
Antiviral Agents
Anti-Infective Agents