Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Pediatric Patients

Pharmacological Action Clinical Trial

Official title:

Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Daul Therapy in Egyptian Pediatric Patients With Chronic Hepatitis C Infection. A Prospective, Randomized, Multicenter Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02985281
• Other study ID #: 00114/2016
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: November 21, 2016
• Last updated: December 16, 2016
• Start date: December 2016
• Est. completion date: September 2017

Study information

• Verified date: December 2016
• Source: National Liver Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial Summary

Evaluation of Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Egyptian Pediatric Patients With Chronic Hepatitis C Infection aged 10- 18 years old.

Description:

Male or female child ≥ 10 years and ≤ 18 years of age chronically infected with hepatitis C virus, willing and able to complete all study visits and procedures. Acceptance from the parents will be recruited for giving a verbal and written informed consent. Patient with childs Pugh class B or C, compensated cirrhosis may be enrolled. Patient with cirrhosis with their alpha fetoprotein is more than 100 ng/ml and patient with coinfection of Hepatitis B virus or HIV will be excluded. Participation in the study procedures is anticipated to last up to 40 weeks including a screening and eligibility assessment phase (4 weeks duration), a 24- week treatment phase, and 12- week post treatment follow up phase.

A detailed treatment log of the returned investigational product will be established with the investigator (or the pharmacist) and countersigned by the investigator and the monitoring team.

Compliance is assessed by counting the number of returned tablets at each visit.

A discontinuation is defined as a period with at least seven consecutive days without study drug intake.

Safety and efficacy will be compared between cirrhotic versus non-cirrhotic subjects in multivariate model to test the impact of this pretreatment characteristic on safety, tolerability and efficacy endpoints.

Safety analysis:clinical adverse events will be displayed by body system (soc) for each study subject and by treatment group, using MedDRA coding. Summary of statistics of safety and efficacy endpoints will be displayed by stratification parameters.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 41
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

Male or female child = 10 years and = 18 years of age chronically infected with hepatitis C virus.

willing and able to complete all study visits and procedures. Acceptance from the parents will be recruited for giving a verbal and written informed consent.

Patient with child,s Pugh class B or C, compensated cirrhosis may be enrolled.

Exclusion Criteria:

1. Patient with cirrhosis with their alpha fetoprotein is more than 100 ng/ml.

2. Patient with coinfection of hepatitis B virus or Human Immunodeficiency Virus will be excluded.

3. Creatinine clearance < 50 ml/minute.

4. Albumin<3 gm/dl.

5. aspartate aminotransferase or alanine aminotransferase > 10 upper limit of normal.

6. Pregnant and lactating females.

7. Associated morbidity such as uncontrolled diabetes mellitus, schistosomiasis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacological Action

Intervention

Drug:
• Sofosbuvir Oral Product
direct acting antiviral drug for HCV infection
• Ribavirin
antiviral drug for HCV infection

Locations

Country	Name	City	State
Egypt	National liver institute	Segin el Kom	Menofia

Sponsors (2)

Lead Sponsor	Collaborator
National Liver Institute, Egypt	Pharco Pharmaceuticals

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of SVR12 in both treatment groups after 12 following completion of treatment (SVR12)	incidence of SVR12 in both treatment groups after 12 weeks following completion of treatment (SVR12)	40 weeks including a screening and eligibility assessment phase (4 weeks duration), a 24- week treatment phase, and 12- week post treatment follow up phase.	Yes
Secondary	assessment of the nature, severity and frequency of the adverse effects and absolute values and changes over time from pre-dose values for hematology clinical chemistry, urine analysis, vital signs and ECG parameters.	Safety and tolerability are assessed by: the nature, severity and frequency of the adverse effects and absolute values and changes over time from pre-dose values for hematology clinical chemistry, urine analysis, vital signs and ECG parameters. Clinical adverse events will be displayed by body system (SOC) for each study subject and by treatment group, using MedDRA coding. Absolute laboratory values, changes and its graded abnormalities will be displayed) for each study subject and by treatment group. The proportions of subjects experiencing Clinical adverse events and laboratory abnormalities of a given type will be computed and presented along with descriptive statistics. Vital signs data will be similarly assessed, and any post baseline changes in physical examination findings will be summarized in tubular form, by subject and by treatment cohort.; Summary statistics of efficacy and safety end points will be displayed by stratification parameters	40 weeks including a screening and eligibility assessment phase (4 weeks duration), a 24- week treatment phase, and 12- week post treatment follow up phase.	Yes