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NCT03961828
Hyalornic Acid Level in β-Thalassemic Children Treated for Hepatitis C Virus
Phase 4 trial testing Ledipasvir 90 MG / Sofosbuvir 400 MG [Harvoni] in Beta-Thalassemia in 50 participants. Completed in 1 March 2019.
31 December 2018
Quick facts
| Lead sponsor | Tanta University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 October 2017 |
| Primary completion | 31 December 2018 |
| Estimated completion | 1 March 2019 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Ledipasvir 90 MG / Sofosbuvir 400 MG [Harvoni] — full drug profile →
Conditions studied
- Beta-Thalassemia — all drugs for Beta-Thalassemia →
- Hepatitis C — all drugs for Hepatitis C →
Sponsor
Tanta University
Who can join
Adults 12 to 18, any sex, with Beta-Thalassemia or Hepatitis C. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with transfusion dependent Beta Thalassemia suffer from a high incidence of Hepatitis C infection especially in developed countries as Egypt. In our patients we also found a high correlation between hepatitic C infection and Liver fibrosis. in this study we offer our patients treatment with Direct antiviral drugs and assessed the degree of fibrosis before and after treatment. We tested Hyalornic acid as a predictor of the degree of fibrosis before and after treatment.
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 NCT03961828
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06308159 — An Open-label Study of a Gene Therapy Product (Vebeglogene Autotemcel) in Transfusion Dependent Beta-Thalassemia · Phase 1, PHASE2 · recruiting
- NCT06065189 — Base-edited Autologous Hematopoietic Stem Cell Transplantation in Treating Patients With β-thalassemia Major · EARLY_PHASE1 · active not recruiting
Other Tanta University trials
Trials by the same sponsor.
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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 NCT03961828 (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 Tanta University
- Last refreshed: 23 May 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/NCT03961828.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing