Last reviewed · How we verify
NCT05248919
Therapy for Hepatitis C Virus (HCV) in Primary Treatment Failure in Pakistan
NA trial testing Epclusa (nucleotide HCV NS5B polymerase inhibitors). in Hepatitis C in 318 participants. Enrolling by invitation.
1 September 2027
Quick facts
| Lead sponsor | Queen Mary University of London |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 318 |
| Start date | 1 June 2023 |
| Primary completion | 1 September 2027 |
| Estimated completion | 1 September 2027 |
| Sites | 1 location across Pakistan |
Drugs / interventions tested
- Epclusa (nucleotide HCV NS5B polymerase inhibitors). — full drug profile →
Conditions studied
- Hepatitis C — all drugs for Hepatitis C →
Sponsor
Queen Mary University of London
Who can join
Adults 18 to 100, any sex, with Hepatitis C. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Determine sustained virological response rate (SVR)
Time frame: 36+/- 2 weeks from the point of randomisation
Sustained virological response (SVR) defined as proportion of patients who are HCV RNA negative with a sensitive molecular test (sensitivity \<100 IU/ml) 36 +/- 2 weeks from the time of randomisation. 2\. To determine the proportion of people with decompensated cirrhosis who achieve a sustained virological response (SVR) 36 weeks (+/-2 weeks) after first dose of medication (sofosbuvir/velpatasvir
Sponsor's own description
This trial is linked to a largescale observational study determining the efficacy of sofosbuvir/daclatasvir in people in Pakistan (involving a separate protocol). The observational study will identify a cohort of patients who have not responded to first-line antiviral therapy (sofosbuvir plus daclatasvir) and the optimal treatment for these patients is unclear. This trial will address this issue by comparing two second-line treatment regimens to determine the preferred treatment option.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05248919
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepatitis C
Currently open trials in the same condition.
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- NCT06367465 — Feasibility and Acceptability of HCV Treatment in Pregnancy · recruiting
- NCT05668780 — Buprenorphine Integration Research and Community Health · NA · active not recruiting
- NCT05208697 — Tele-Harm Reduction · NA · active not recruiting
Other Queen Mary University of London trials
Trials by the same sponsor.
- NCT07246005 — LVT DURATION: Pilot Study of Anticoagulation Duration for Left Ventricular Thrombus · Phase 2 · not yet recruiting
- NCT07165678 — CTCA Prior to Invasive Angiography in Post-Bypass Patients (BYPASS CTCA 2) · NA · not yet recruiting
- NCT06937372 — Delivery and Implementation of a Randomised Crossover Trial on Thrombosis · NA · not yet recruiting
- NCT06600438 — Slow-SPEED UK: A Double-Blind Randomised Feasibility Trial · NA · not yet recruiting
- NCT06987045 — Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study · 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 NCT05248919 (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 Queen Mary University of London
- Last refreshed: 20 November 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/NCT05248919.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing