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

Primary Purpose

Hepatitis C Virus Infection, Response to Therapy of

Status

Unknown status

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)

8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection, Response to Therapy of

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Willing and able to provide written informed consent.
12-18 years
HCV RNA ≥ 104 IU/mL at screening.
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
Screening ECG without clinically significant abnormalities.
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
Patient has not been treated with any investigational drug or device within 30 days of the screening visit.

Exclusion Criteria:

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

Sites / Locations

Egyptian Liver Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1

Arm 2

Short Track

Arm Description

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.

Treatment-experienced is defined as: IFN Intolerant Non-response Relapse/Breakthrough

Treatment-naïve or Treatment-experienced who achived very rapid virological responce - Negative HCV PCR after treatment with (Sofosbuvir 400mg/Ledipasvir 90mg) for 1 week

Outcomes

Primary Outcome Measures

SVR12

sustained viral response 12 weeks after discontinuation of therapy (SVR12)

Secondary Outcome Measures

SVR4

sustained viral response 4 weeks after discontinuation of therapy (SVR4)

Full Information

NCT ID

NCT03343444

First Posted

March 27, 2017

Last Updated

May 23, 2018

Sponsor

Egyptian Liver Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03343444

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 15, 2017 (Actual)

Primary Completion Date

November 1, 2018 (Anticipated)

Study Completion Date

May 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Egyptian Liver Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Virus Infection, Response to Therapy of

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Description

Treatment-experienced is defined as: IFN Intolerant Non-response Relapse/Breakthrough

Arm Title

Short Track

Arm Type

Experimental

Arm Description

Treatment-naïve or Treatment-experienced who achived very rapid virological responce - Negative HCV PCR after treatment with (Sofosbuvir 400mg/Ledipasvir 90mg) for 1 week

Intervention Type

Drug

Intervention Name(s)

12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)

Other Intervention Name(s)

Normal track

Intervention Description

Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)

Other Intervention Name(s)

Short track

Intervention Description

Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 8 weeks

Primary Outcome Measure Information:

Title

SVR12

Description

sustained viral response 12 weeks after discontinuation of therapy (SVR12)

Time Frame

12 weeks after discontinuation of therapy

Secondary Outcome Measure Information:

Title

SVR4

Description

sustained viral response 4 weeks after discontinuation of therapy (SVR4)

Time Frame

4 weeks after discontinuation of therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Willing and able to provide written informed consent. 12-18 years HCV RNA ≥ 104 IU/mL at screening. 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 Screening ECG without clinically significant abnormalities. 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 Patient has not been treated with any investigational drug or device within 30 days of the screening visit. Exclusion Criteria: Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis). Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV). History of solid organ transplantation. Current or prior history of clinical hepatic decompensation (eg, ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome). History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug. History of significant pulmonary disease, significant cardiac disease or porphyria. History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. Donation or loss of more than 400 mL blood within 2 months prior to Baseline/Day 1. Known hypersensitivity to the study investigational medicinal product, the metabolites, or formulation excipients.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gamal Shiha, MD

Organizational Affiliation

Egyptian Liver Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Egyptian Liver Hospital

City

Mansourah

State/Province

Dakahlia

ZIP/Postal Code

36681

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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