Clinical trial NCT02985281: Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Pediatric Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pharmacological Action
Keywords: direct acting antiviral drugs, chronic hepatitis C virus infection
Lead sponsor: National Liver Institute, Egypt
Sponsor class: OTHER
Collaborators: name: Pharco Pharmaceuticals
First posted: 2016-12-07
Enrollment: 41
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of SVR12 in both treatment groups after 12 following completion of treatment (SVR12)
timeFrame: 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:
measure: 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.
timeFrame: 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.
Other outcomes:
Locations:
city: Segin el Kom
country: Egypt
facility: National liver institute
state: Menofia
Study officials:
affiliation: National Liver Institute, Egypt
name: Behairy Behairy, professor
role: STUDY_DIRECTOR
References: