A Phase 4 interventional study of Combined therapy LDV and SOF in Hepatitis C Genotype 4, sponsored by Yassin Abdelghaffar Charity Center for Liver Disease and Research. Status unknown at 1 site in Egypt. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-11-16.
Sponsored by Yassin Abdelghaffar Charity Center for Liver Disease and Research · Phase 4, Interventional, and Treatment
Among 69 studies in Hepatitis C with a site in Egypt — 1 open to participants now, 2 under way, 2 of them phase 3. Hepatitis C · Egypt.
Among the 69 studies in Hepatitis C with a site in Egypt, this one is the 37th largest by planned enrollment of the 45 interventional ones that give a count, is one of 10 that started in 2018, is one of 11 in phase 4, and was the 49th 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 69 studies in Hepatitis C with a site in Egypt is open now. Recruiting first, the newest first:
Tanta University · Sites in Egypt
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
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.
69 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 11 · Phase 3 21 · Phase 4 11
First in 2002; this study’s year is marked. 10 started in 2018.
This study's planned enrollment of 25 is below the median of 72 across 1,223 interventional studies indexed under Hepatitis C.
Median enrollment 80 across the 45 interventional studies, 100 across the 24 observational. Of the 37 that completed or were terminated, 6 (16%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 69 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.
2 of the studies in Hepatitis C with a site in Egypt that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07770984Phase 3Tanta UniversityTreatment of CKD Patients With HCV | 2026-11-15 |
| NCT07037277Phase 3Atea Pharmaceuticals, Inc.C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV | 2026-12 |
Among the 69 studies in Hepatitis C with a site in Egypt, 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 study of twenty-five 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 ledipasvir (LDV) and sofosbuvir (SOF) 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 LDV and SOF
All patients will receive ledipasvir/sofosbuvir fixed dose combination for 12 weeks. Patients weighing 35 kg or more will receive the adult dose: ledipasvir (90 mg)/sofosbuvir (400 mg). Patients weighing below 35 kg will receive half the adult dose: ledipasvir (45 mg)/sofosbuvir (200 mg).
Also known as: ledipasvir and sofosbuvir
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
No publications or documents are linked to this record.
Started Aug 2018 (actual). Primary completion is estimated for Mar 2019, 7 months after the start.
Of 56 non-industry phase 4 interventional studies under Hepatitis C, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 49. This study's planned 7 months is below that.
Counting every sponsor, half of 58 studies reached it within 24 months; a quarter within 16 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Yassin Abdelghaffar Charity Center for Liver Disease and Research