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NCT03250910
Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients
Phase 4 trial testing Sofosbuvir and Velpatasvir in Hepatitis C Virus Infection, Response to Therapy of in 228 participants. Completed in 31 October 2017.
15 July 2017
Quick facts
| Lead sponsor | National Taiwan University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 228 |
| Start date | 1 August 2016 |
| Primary completion | 15 July 2017 |
| Estimated completion | 31 October 2017 |
| Sites | 2 locations across Taiwan |
Drugs / interventions tested
- Sofosbuvir and Velpatasvir — full drug profile →
- Ribavirin — full drug profile →
Conditions studied
- Hepatitis C Virus Infection, Response to Therapy of — all drugs for Hepatitis C Virus Infection, Response to Therapy of →
- Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
Sponsor
National Taiwan University Hospital
Who can join
20 and older, any sex, with Hepatitis C Virus Infection, Response to Therapy of or Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Data are limited regarding the effectiveness and safety of generic velpatasvir plus sofosbuvir (VEL/SOF) with or without ribavirin (RBV) for the treatment of hepatitis C virus (HCV) in patients with human immunodeficiency virus (HIV) coinfection. We aim to compare the effectiveness and safety of VEL/SOF with and without RBV for 12 weeks in HIV/HCV-coinfected and HCV-monoinfected patients The antiviral responses and the adverse events (AEs) are compare between the two groups. The characteristics potentially related to sustained virologic response 12 weeks off therapy (SVR12) are analyzed.
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 NCT03250910
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sofosbuvir and Velpatasvir
Trials testing the same drug.
- NCT03818308 — Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir · Phase 2 · completed
Other recruiting trials for Hepatitis C Virus Infection, Response to Therapy of
Currently open trials in the same condition.
- NCT05361603 — Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures · recruiting
Other National Taiwan University Hospital trials
Trials by the same sponsor.
- NCT06936917 — Timing for Computed Tomography and Post-Resuscitation Care on Short-Term Outcomes in Out-of-Hospital Cardiac Arrest · not yet recruiting
- NCT05396222 — A Prospective Study of the Safety and Efficacy of 3D-printed Non-rigid Biomimetic Implant in Cervical and Thoracolumbar · NA · not yet recruiting
- NCT07532356 — Integrating Tumor Genomics and Urinary Exosomal Proteomics to Establish a Multi-Layer Biomarker Framework for Early Risk · not yet recruiting
- NCT07317310 — The NTU JO-SMART Study · NA · not yet recruiting
- NCT07382024 — Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation · NA · not yet 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 NCT03250910 (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 Taiwan University Hospital
- Last refreshed: 8 December 2017
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/NCT03250910.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing