A Phase 3 interventional study of Combined Therapy SOF and DCV in Hepatitis C Genotype 4, sponsored by Yassin Abdelghaffar Charity Center for Liver Disease and Research. Completed at 1 site in Egypt. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by Yassin Abdelghaffar Charity Center for Liver Disease and Research · Phase 3, Interventional, and Treatment
Among 94 studies testing sofosbuvir in Hepatitis C — 1 open to participants now, 3 under way, none of them phase 3. Sofosbuvir · Hepatitis C.
Among the 94 studies testing sofosbuvir in Hepatitis C, this one is the 63rd largest by enrollment, is one of 11 that started in 2017, is one of 30 in phase 3, and was the 62nd registered.
1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.
Browse Hepatitis C studies →1 of the 94 studies testing sofosbuvir in Hepatitis C is open now. Recruiting first, the newest first:
Eastern Idaho Public Health
Sofosbuvir: first FDA approval 2013 (SOVALDI), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 56 Hepatitis C studies recruiting now, 43 (77%) set no upper age limit and 6 (11%) stop at 75 or younger; 10 take children under 18; 26 take healthy volunteers.
This study: 8 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
94 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 34 · Phase 3 31 · Phase 4 22
First in 2010; this study’s year is marked. 11 started in 2017.
This study's enrollment of 40 is below the median of 72 across 1,223 interventional studies indexed under Hepatitis C.
Median enrollment 75 across the 94 interventional studies. Of the 78 that completed or were terminated, 50 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
48 of 94 have an industry lead sponsor. The 10 most frequent:
Yassin Abdelghaffar Charity Center for Liver Disease and Research is the lead sponsor of 3 studies on the registry; none are open to participants now.
Yassin Abdelghaffar Charity Center for Liver Disease and Research has 2 studies filed under Hepatitis C — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 94 studies testing sofosbuvir in Hepatitis C, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Combined Therapy SOF and DCV
Drug page: Sofosbuvir
1 whole or half tablet sofosbuvir and 1 whole or half tablet daclatasvir per day SOF dosage: 400 mg/day for greater than 45 kg weight patients; 200 mg/day for 17 kg to 45 kg patients DCV dosage: 60 mg/day for greater than 45 kg weight patients; 30 mg for 17 kg to 45 kg patients
Also known as: sofosbuvir, daclatasvir
Incidence of Treatment Emergent Adverse Events
The presence of any adverse effects will be used to characterize this outcome measure.
Time frame: During the 12 weeks of treatment.
Sustained Viral Clearance
HCV RNA qPCR will be used to determine if the target of viral clearance has been established. Detection limit of the kit is 12 IU/ml.
Time frame: At Week 12 after end of treatment.
Plan to share: No
Ran from Mar 2017 to primary completion in Feb 2018, 11 months.
Of 90 phase 3 interventional studies under Hepatitis C, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 22. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sofosbuvir
Yassin Abdelghaffar Charity Center for Liver Disease and Research