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NCT06119659
Safety and Efficacy Clinical Study of Severe Hemophilia B Treatment With KL001
EARLY_PHASE1 trial testing Low dose KL001 in Hemophilia B Without Inhibitor in 9 participants. Status unknown.
30 June 2024
Quick facts
| Lead sponsor | Zhejiang University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 20 November 2023 |
| Primary completion | 30 June 2024 |
| Estimated completion | 10 July 2025 |
Drugs / interventions tested
- Low dose KL001 — full drug profile →
- Middle dose KL001 — full drug profile →
- High dose KL001 — full drug profile →
Conditions studied
- Hemophilia B Without Inhibitor — all drugs for Hemophilia B Without Inhibitor →
Sponsor
Zhejiang University
Who can join
18 and older, male only, with Hemophilia B Without Inhibitor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL001 injection solution in hemophilia B subjects with ≤2 IU/dl residual FIX levels.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06119659
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Low dose KL001
Trials testing the same drug.
- NCT06125756 — Safety and Efficacy Clinical Study of Severe Hemophilia B Treatment With KL001 · EARLY_PHASE1 · unknown
Other recruiting trials for Hemophilia B Without Inhibitor
Currently open trials in the same condition.
- NCT06569108 — Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B Without Inhibitors · Phase 3 · active not recruiting
Other Zhejiang University trials
Trials by the same sponsor.
- NCT07487402 — Safety and Efficacy of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients With Unresectable Recurr · EARLY_PHASE1 · not yet recruiting
- NCT07480044 — A Phase II Clinical Two-Stage Study of Transcranial Magnetic Stimulation in Preventing Postoperative Delirium in Elderly · NA · not yet recruiting
- NCT07467005 — Video Double-Lumen Tube for Secondary Pulmonary Resection · NA · not yet recruiting
- NCT07429461 — Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia · EARLY_PHASE1 · recruiting
- NCT07240766 — HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation · Phase 2 · 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 NCT06119659 (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 Zhejiang University
- Last refreshed: 7 November 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/NCT06119659.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing