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NCT03764345
Eight Weeks Sofosbovir/Ledipasvir in HCV Infected Children Aged 4 to 10 Years
NA trial testing Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir) in Hepatitis C, Chronic in 30 participants. Completed in 2 July 2019.
2 July 2019
Quick facts
| Lead sponsor | National Liver Institute, Egypt |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 6 December 2018 |
| Primary completion | 2 July 2019 |
| Estimated completion | 2 July 2019 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir) — full drug profile →
Conditions studied
- Hepatitis C, Chronic — all drugs for Hepatitis C, Chronic →
- Children, Only — all drugs for Children, Only →
Sponsor
National Liver Institute, Egypt
Who can join
Adults 3 to 12, any sex, with Hepatitis C, Chronic or Children, Only. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 treat children aged between 3 and 12 years with half the adult dose of Sofosbuvir/Ledipasvir combination (Heterosofir).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03764345
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepatitis C, Chronic
Currently open trials in the same condition.
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- NCT04943588 — Treating Hepatitis C in Pakistan. Strategies to Avoid Resistance to Antiviral Drugs · recruiting
- NCT03520660 — People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents · Phase 4 · active not recruiting
- NCT03200379 — Nation-wide Hepatitis C Virus (HCV) Registry in Taiwan · recruiting
Other National Liver Institute, Egypt trials
Trials by the same sponsor.
- NCT07331142 — CBD Stenting vs Non-Stenting for Choledocholithiasis · NA · completed
- NCT06948279 — Immediate vs. Elective Endoscopic Removal of Large CBD Stones in High-Risk Elderly Patients · NA · completed
- NCT07337291 — Double Stent for Biliary Stones in Cirrhotic Patients · NA · completed
- NCT05184491 — Nitazoxanide and Lansoprazole Based Regimens for H. Pylori Management · Phase 4 · unknown
- NCT06384443 — Proton Pump Inhibitors in Cirrhotic Patients · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03764345 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Liver Institute, Egypt
- Last refreshed: 17 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03764345.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing