Last reviewed · How we verify
NCT05895448
Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics
Phase 4 trial testing velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) . in Chronic Hepatitis C in 125 participants. Status unknown.
1 November 2023
Quick facts
| Lead sponsor | Center For Hepatitis C, Atlanta, GA |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 125 |
| Start date | 1 March 2018 |
| Primary completion | 1 November 2023 |
| Estimated completion | 1 January 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) . — full drug profile →
Conditions studied
- Chronic Hepatitis C — all drugs for Chronic Hepatitis C →
- People Who Inject Drugs — all drugs for People Who Inject Drugs →
Sponsor
Center For Hepatitis C, Atlanta, GA — full company profile →
Who can join
Adults 18 to 75, any sex, with Chronic Hepatitis C or People Who Inject Drugs. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Direct antiviral therapy (standard of care) administered to chronic hepatitis C-infected patients, in two hepatology clinics, who had used intravenous drugs in the past 6 months of signing informed consent (IC). This cohort was compared to concurrently treated chronic hepatitis C patients who were not intravenous drug users, who signed IC in these same clinics. Follow-up expected two years after cure and relapse rates recorded. Primary end point was SVR rate and secondary end points included reinfection rates in follow-up period.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05895448
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Hepatitis C
Currently open trials in the same condition.
- NCT06180590 — The Efficacy of Vosevi in Treating DAA-experienced Patients · recruiting
- NCT03993925 — Enhancing Access to Care for Chronic Hepatitis C Infected Populations in Hong Kong · active not recruiting
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 NCT05895448 (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 Center For Hepatitis C, Atlanta, GA
- Last refreshed: 8 June 2023
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/NCT05895448.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing