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NCT03819322
The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients
Phase 2 trial testing sofosbuvir/velpatasvir in Liver Transplant in 73 participants. Completed in 17 March 2025.
17 March 2025
Quick facts
| Lead sponsor | Fernanda P Silveira, MD, MS |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 73 |
| Start date | 15 August 2019 |
| Primary completion | 17 March 2025 |
| Estimated completion | 17 March 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- sofosbuvir/velpatasvir
Conditions studied
- Liver Transplant — all drugs for Liver Transplant →
- Hepatitis C — all drugs for Hepatitis C →
Sponsor
Fernanda P Silveira, MD, MS — full company profile →
Who can join
18 and older, any sex, with Liver Transplant or Hepatitis C. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, pilot trial to test the safety and efficacy of transplantation of livers from Hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the liver transplant waitlist. Treatment and prophylaxis will be administered, using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).
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 NCT03819322
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of sofosbuvir/velpatasvir
Trials testing the same drug.
- NCT06533319 — Hepatitis C Treatment in Idaho County Jails · NA · not yet recruiting
- NCT03809533 — The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients · Phase 2 · active not recruiting
- NCT03235154 — A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic · Phase 4 · completed
- NCT03222531 — Expanding the Pool in Orthotopic Heart Transplantation · Phase 2 · active not recruiting
- NCT03032666 — Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Tri · Phase 4 · completed
Other recruiting trials for Liver Transplant
Currently open trials in the same condition.
- NCT06254248 — Safety of Atezolizumab-Bevacizumab in Liver Transplanted Patients With Advanced Hepatocellular Carcinoma · Phase 2 · recruiting
- NCT06832189 — EVR and EPO for Liver Transplant Tolerance · Phase 1 · recruiting
- NCT07216508 — Liver Transplant CGM · recruiting
- NCT07086989 — Cardiovascular Risk in Children With Chronic Conditions Study · recruiting
- NCT06813508 — Prognostic Factors for HCC and Liver Transplantation in Patients With MASLD/MASH · recruiting
Other Fernanda P Silveira, MD, MS trials
Trials by the same sponsor.
- NCT05041426 — Letermovir for CMV Prevention After Lung Transplantation · Phase 2 · 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 NCT03819322 (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 Fernanda P Silveira, MD, MS
- Last refreshed: 12 August 2025
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/NCT03819322.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing