An interventional study of Sofosbuvir/Daclatasvir in Hepatitis C,Chronic Children, Only, sponsored by National Liver Institute, Egypt. Completed at 1 site in Egypt. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by National Liver Institute, Egypt · Not applicable, Interventional, and Treatment
Recently the era of direct-acting antiviral drugs for hepatitis C treatment has changed the world map of HCV. Results in adults are promising. FDA approved only two drugs in the pediatric age group 12 to 17 years. Younger children are still on the wait list for treatment. The current study aimed to study the efficacy and safety of combined sofosbuvir (SOF)/daclatasvir (DCV) in children with hepatitis C virus infection aged 6-18 years.
The WHO has declared hepatitis C a global health problem, with ∼ 3% of the world's population (roughly 170-200 million individuals) infected with Hepatitis C virus (HCV). Egypt has the highest prevalence of HCV in the world, ranging from 6 to 28%, with an average of ∼ 13.8% in the general population. Approximately 90% of Egyptian HCV isolates belong to a single subtype, 4a .
Hepatitis C virus is a major cause of chronic liver disease and a principal reason for liver transplant; approximately 170 million people worldwide are chronically infected . The successful development of direct-acting antivirals (DAAs) that are active against hepatitis C virus has transformed chronic hepatitis C infection from a condition requiring complex therapies with unsatisfactory outcomes to one that can be easily treated with few contraindications and side-effects. Since 2011, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved eight oral DAA regimens for the treatment of adults with chronic hepatitis C. Investigation into DAAs for children has been slower .
Combination therapies with highly effective DAA regimes, such as sofos-buvir/ledipasvir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, sofos-buvir/daclatasvir, sofosbuvir/ribavirin and others, are available for use in children. Most of the DAA regimens have either received or are pending to receive regulatory approval by different medical/drug agencies for use in children and adolescents. Pan-genotypic regimens are also available in children and adolescents, and these regimens can be used while skipping genotype testing.
Previous study found that daclatasvir 30 mg once daily was predicted to achieve effective and safe exposures in children 14 to \<35 kg, perhaps down to 10 kg.
Other study revealed that combined sofosbuvir (SOF)/daclatasvir (DCV) for HCV Genotype 4 in children aged 8 to 18 years or weighing 17 kg or more was found to be effective and safe .
Also other study tested the effects of dual sofosbuvir/daclatasvir (SOF/DCV) therapy in the treatment of chronic HCV in survivors of hematologic malignancy in pediatric age group and found that SOF/DCV combined therapy could be used safely and effectively in the treatment of chronic HCV genotype-4 infection in leukemia/lymphoma treated children
950 studies on the registry are indexed under Hepatitis C, Chronic; 8 are open to participants now.
This study's enrollment of 42 is below the median of 90 across 696 interventional studies indexed under Hepatitis C, Chronic.
Browse Hepatitis C, Chronic studies →National Liver Institute, Egypt is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients weighted less than 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (200/30mg) daily for 12 weeks. Patients weighted more than or equal 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (400/60mg) daily for 12 weeks
Drug: Sofosbuvir/Daclatasvir
Drug pages: Sofosbuvir · Daclatasvir
Patients weighted less than 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (200/30 mg) daily for 12 weeks. Patients weighted more than or equal to 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (400/60 mg) daily for 12 weeks
Side effect 2 Number of patients with Headache
Number of patients with Headache
Time frame: 12 weeks
Side effect 1 Number of patients with fatigue
Number of patients with fatigue
Time frame: 12 weeks
Side effect 3 Number of patients with nausea
Number of patients with nausea
Time frame: 12 weeks
Side effect 4 Number of patients with diarrhea
Number of patients with diarrhea
Time frame: 12 weeks
Side effect 5 Number of patients with insomnia
Number of patients with insomnia
Time frame: 12 weeks
Side effect 6 Number of patients with weakness
Number of patients with weakness
Time frame: 12 weeks
Side effect 7 Number of patients with bradycardia
Number of patients with bradycardia
Time frame: 12 weeks
Side effect 8 Number of patients with cough
Number of patients with cough
Time frame: 12 weeks
Side effect 9 Number of patients with myalgia
Number of patients with myalgia
Time frame: 12 weeks
Side effect 10 Number of patients with dyspnea
Number of patients with dyspnea
Time frame: 12 weeks
Side effect 11 Number of patients with irritability
Number of patients with irritability
Time frame: 12 weeks
Side effect 12 Number of patients with dizziness
Number of patients with dizziness
Time frame: 12 weeks
Side effect 13 Number of patients with depression
Number of patients with depression
Time frame: 12 weeks
Side effect 14 Number of patients with skin rash
Number of patients with skin rash
Time frame: 12 weeks
HCV-RNA PCR by the end of therapy
HCV-RNA PCR at week 12
Time frame: 12 weeks
HCV-RNA PCR after 20 weeks for SVR
HCV-RNA PCR at week 20
Time frame: 20 weeks
Treatment safety-1 Alanine transaminase serum level
Alanine transaminase serum level
Time frame: 12 weeks
Treatment safety-2 Aspartate transaminase serum level
Aspartate transaminase serum level
Time frame: 12 weeks
Treatment tolerability- 1 Patient height
measurement of height
Time frame: 20 weeks
Treatment tolerability-2 Body weight
measurement of weight
Time frame: 20 weeks
Plan to share: Yes — Plan to Share IPD
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sofosbuvir · Daclatasvir
National Liver Institute, Egypt