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

NCT02985281 | Unknown Phase 2 DMC

• 1 other identifier: 00114/2016
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacological Action

Keywords

direct acting antiviral drugs, chronic hepatitis C virus infection

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

  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.

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

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.

Drug: Sofosbuvir Oral Product; Drug: Ribavirin

Arm 2

ACTIVE COMPARATOR

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.

Drug: Sofosbuvir Oral Product; Drug: Ribavirin

Interventions

Sofosbuvir Oral Product DRUG

direct acting antiviral drug for HCV infection

Also known as: Gratisovir

Arm 1; Arm 2

Ribavirin DRUG

antiviral drug for HCV infection

Arm 1; Arm 2

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patient with cirrhosis with their alpha fetoprotein is more than 100 ng/ml.
• Patient with coinfection of hepatitis B virus or Human Immunodeficiency Virus will be excluded.
• Creatinine clearance \< 50 ml/minute.
• Albumin\<3 gm/dl.
• aspartate aminotransferase or alanine aminotransferase \> 10 upper limit of normal.
• Pregnant and lactating females.
• Associated morbidity such as uncontrolled diabetes mellitus, schistosomiasis.

Sponsors & Collaborators

• National Liver Institute, Egypt: lead
• Pharco Pharmaceuticals: collaborator

Study Sites (1)

National liver institute

Sijīn al Kawm, Menofia, 32714, Egypt

Location

MeSH Terms

Interventions

Ribavirin

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Behairy Behairy, professor

  National Liver Institute, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pediatric hepatology.

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: December 7, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 19, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)