Last reviewed · How we verify
NCT04596475
Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor
Phase 1, PHASE2 trial testing glecaprevir/pibrentasvir (GLE/PIB) in Hepatitis C in 12 participants. Completed in 21 April 2022.
21 April 2022
Quick facts
| Lead sponsor | University of California, San Diego |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 12 |
| Start date | 28 May 2021 |
| Primary completion | 21 April 2022 |
| Estimated completion | 21 April 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- glecaprevir/pibrentasvir (GLE/PIB) — full drug profile →
Conditions studied
- Hepatitis C — all drugs for Hepatitis C →
- Hepatitis C Virus Infection, Response to Therapy of — all drugs for Hepatitis C Virus Infection, Response to Therapy of →
Sponsor
University of California, San Diego
Who can join
18 and older, any sex, with Hepatitis C or Hepatitis C Virus Infection, Response to Therapy of. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial will be done in participants who undergo transplantation of heart, kidney or lung at University of California, San Diego (UCSD) and receive a hepatitis C infected donor organ. In this trial, the plan is to start hepatitis C treatment just before transplant surgery and treat for a short one-week course to see if hepatitis C infection can be prevented in the transplant recipient. The plan is to perform this trial in 10 participants and if successful, the next step is to try to make it standard of care as prevention of infection is better than treating hepatitis C after discharge from transplant surgery (which is usually a 12 week standard treatment).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Pilot Trial for Prevention of Hepatitis C Virus Transmission From Donor to Organ Transplant Recipient With Short-Course Glecaprevir/Pibrentasvir.
Ramirez-Sanchez C, Kozuch J, Shah MM, Berumen J, et al · · 2022 · cited 6× · PMID 36420058 · DOI 10.1093/ofid/ofac550
Verify or expand the search:
- PubMed search for NCT04596475
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04596475 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Diego
- Last refreshed: 24 May 2022
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/NCT04596475.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing