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Trial record 6 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

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

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ClinicalTrials.gov Identifier: NCT03343444
Recruitment Status : Enrolling by invitation
First Posted : November 17, 2017
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Egyptian Liver Hospital

Brief Summary:
Randomized, open-label study in treatment naïve and treatment experienced, adolescence to determine the efficacy of Sofosbuvir 400mg/ledipasvir 90mg in treatment naïve and treatment-experienced adolescence. Hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12)

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection, Response to Therapy of Drug: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) Drug: 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents
Actual Study Start Date : April 15, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Active Comparator: Arm 1
Treatment-naïve is defined as having never received treatment for HCV with any interferon (IFN), ribavirin , or other approved or experimental HCV specific direct acting antivirals.
Drug: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)
Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 12 weeks
Other Name: Normal track

Active Comparator: Arm 2

Treatment-experienced is defined as:

  1. IFN Intolerant
  2. Non-response
  3. Relapse/Breakthrough
Drug: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)
Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 12 weeks
Other Name: Normal track

Experimental: Short Track
Treatment-naïve or Treatment-experienced who achived very rapid virological responce - Negative HCV PCR after treatment with (Sofosbuvir 400mg/Ledipasvir 90mg) for 1 week
Drug: 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)
Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 8 weeks
Other Name: Short track




Primary Outcome Measures :
  1. SVR12 [ Time Frame: 12 weeks after discontinuation of therapy ]
    sustained viral response 12 weeks after discontinuation of therapy (SVR12)


Secondary Outcome Measures :
  1. SVR4 [ Time Frame: 4 weeks after discontinuation of therapy ]
    sustained viral response 4 weeks after discontinuation of therapy (SVR4)



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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:

  1. Willing and able to provide written informed consent.
  2. 12-18 years
  3. HCV RNA ≥ 104 IU/mL at screening.
  4. Confirmed chronic HCV infection as documented by either:

    a. a positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or

  5. Screening ECG without clinically significant abnormalities.
  6. Patients must have the following laboratory parameters at screening:

    • ALT (Alanine transaminase) ≤ 10 x the upper limit of normal (ULN)
    • AST (Aspartate Aminotransferase) ≤ 10 x ULN
    • Hemoglobin ≥ 12 g/dL for male, ≥ 11 g/dL for female patients
    • Platelets > 50,000 cells/mm3
    • INR (international normalized ratio) ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
    • Albumin ≥ 3 g/dL
    • HbA1c ≤ 10%
    • Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation
  7. Patient has not been treated with any investigational drug or device within 30 days of the screening visit.

Exclusion Criteria:

  1. Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis).
  2. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
  3. History of solid organ transplantation.
  4. Current or prior history of clinical hepatic decompensation (eg, ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome).
  5. History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
  6. History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug.
  7. History of significant pulmonary disease, significant cardiac disease or porphyria.
  8. History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
  9. Donation or loss of more than 400 mL blood within 2 months prior to Baseline/Day 1.
  10. Known hypersensitivity to the study investigational medicinal product, the metabolites, or formulation excipients.

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): NCT03343444


Locations
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Egypt
Egyptian Liver Hospital
Mansourah, Dakahlia, Egypt, 36681
Sponsors and Collaborators
Egyptian Liver Hospital
Investigators
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Principal Investigator: Gamal Shiha, MD Egyptian Liver Hospital

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Responsible Party: Egyptian Liver Hospital
ClinicalTrials.gov Identifier: NCT03343444     History of Changes
Other Study ID Numbers: PED-ELH-2017
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
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
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Hepatitis, Chronic
Sofosbuvir
Antiviral Agents
Anti-Infective Agents