Clinical trial NCT03080415: Treatment of Egyptian Hepatitis C Genotype 4 Infected Children (and Adolescents) With Combined Sofosbuvir & Daclatasvir
Official title: The Safety and Efficacy of Sofosbuvir & Daclatasvir Combined Therapy for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Genotype 4
Lead sponsor: Yassin Abdelghaffar Charity Center for Liver Disease and Research
Sponsor class: OTHER
Collaborators: name: Egyptian Cure Bank
name: Society of Friends of Liver Patients in the Arab World (SLPAW)
First posted: 2017-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All of the participants will be receiving combined therapy of sofosbuvir and daclatasvir for 12 weeks.
Primary purpose: TREATMENT

Brief summary: This is an open, uncontrolled pilot study of thirty chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety \& efficacy of combined therapy sofosbuvir (SOF) and daclatasvir (DCV) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. Safety will be measured by checking for adverse effects, while efficacy will be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral nucleic acids in blood samples.


Eligibility criteria: Inclusion Criteria:

1. Age: 8-18 years
2. Sex: both sexes
3. Naïve patients, with chronic HCV infection

Exclusion Criteria:

1. Co-infection with Hepatitis B virus (HBV)
2. Other associated chronic liver illness
3. Cirrhotic patients (as indicated by biopsy, fibroscan(F4)
4. Patients with history of hematemesis (non cirrhotic portal hypertension)
5. Patients on drugs known to interact unfavorably with SOF (Amiodarone,..)

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events
timeFrame: During the 12 weeks of treatment.
measure: Sustained Viral Clearance
timeFrame: At Week 12 after end of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Nasr City
country: Egypt
facility: Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
state: Cairo
Study officials:
affiliation: Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
name: Tawhida Y. Abdel Ghaffar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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