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

Hepatitis C Virus Infection, Response to Therapy of Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03343444
• Other study ID #: PED-ELH-2017
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: April 15, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: May 2018
• Source: Egyptian Liver Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: May 31, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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, a1 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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection, Response to Therapy of
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Virus Diseases

Intervention

Drug:
• 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)
Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 12 weeks
• 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)
Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 8 weeks

Locations

Country	Name	City	State
Egypt	Egyptian Liver Hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Egyptian Liver Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR12	sustained viral response 12 weeks after discontinuation of therapy (SVR12)	12 weeks after discontinuation of therapy
Secondary	SVR4	sustained viral response 4 weeks after discontinuation of therapy (SVR4)	4 weeks after discontinuation of therapy