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

NCT ID: NCT02985281

Last Updated: 2016-12-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-09-30

Brief 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.

Detailed 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.

Conditions

Pharmacological Action

Keywords

direct acting antiviral drugs, chronic hepatitis C virus infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

20 patients will be randomly assigned into arm 1; treated for fixed 24 duration with Gratisovir (Sofosbuvir) and Ribavirin. First intervention 'Sofosbuvir oral product' 200 mg tablet with food on daily doses based on body weight (20-29.9 kg will take one 200 mg tab daily); (30-39.9 kg will take 1.5 tab 200 mg daily); (> 40 kg will take 2 tab 200 mg daily).

Second intervention 'Ribavirin oral product' 200 mg tab on (15 mg/kg daily) doses based on body weight.

Group Type: ACTIVE_COMPARATOR

Sofosbuvir Oral Product

Intervention Type: DRUG

direct acting antiviral drug for HCV infection

Ribavirin

Intervention Type: DRUG

antiviral drug for HCV infection

Arm 2

20 patients will be randomly assigned into arm 2; treated as response guided duration; patient who show very rapid virological (undetectable HCV RNA after 2 weeks) will be treated for 16 weeks duration and reset will complete the 24 weeks duration.

Intervention 'Sofosbuvir Oral Product' 200 mg tablet with food on daily doses based on body weight (20-29.9 kg will take one 200 mg tab daily); (30-39.9 kg will take 1.5 tab 200 mg daily); (> 40 kg will take 2 tab 200 mg daily).

Second intervention 'Ribavirin oral product' 200 mg tab on (15 mg/kg daily) doses based on body weight.

Group Type: ACTIVE_COMPARATOR

Sofosbuvir Oral Product

Intervention Type: DRUG

direct acting antiviral drug for HCV infection

Ribavirin

Intervention Type: DRUG

antiviral drug for HCV infection

Interventions

Sofosbuvir Oral Product

direct acting antiviral drug for HCV infection

Intervention Type: DRUG

Ribavirin

antiviral drug for HCV infection

Intervention Type: DRUG

Other Intervention Names

Gratisovir

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharco Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

National Liver Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Samira Abdel-Wahab Abdel- Aziz

lecturer of pediatric hepatology.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Behairy Behairy, professor

Role: STUDY_DIRECTOR

National Liver Institute, Egypt

Locations

National liver institute

Sijīn al Kawm, Menofia, Egypt

Countries

Egypt

Other Identifiers

00114/2016

Identifier Type: -

Identifier Source: org_study_id