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NCT06938659: AFEEL
Low Dose Emicizumab vs Low Dose Factor VIII in Prophylaxis in Hemophilia A Patients
Phase 2, PHASE3 trial testing Emicizumab Injection in Hemophilia A in 20 participants. Not yet recruiting.
31 May 2026
Quick facts
| Lead sponsor | Dhaka Medical College |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 June 2025 |
| Primary completion | 31 May 2026 |
| Estimated completion | 31 July 2026 |
| Sites | 1 location across Bangladesh |
Drugs / interventions tested
- Emicizumab Injection — full drug profile →
- Factor VIII (FVIII) — full drug profile →
Conditions studied
- Hemophilia A — all drugs for Hemophilia A →
Sponsor
Dhaka Medical College
Who can join
Eligibility, any sex, with Hemophilia A. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Low dose factor VIII prophylaxis is practiced around the world. Role of standard dose Emicizumab prophylaxis is well established. Emicizumab is an expensive drug. Standard dose Emicizumab prophylaxis is very expensive for hemophilia A patients and troublesome for government to ensure continuous supply. This study intends to compare low dose Factor VIII prophylaxis with low dose Emicizumab prophylaxis and compare whether low dose Emicizumab is as effective as low dose Factor VIII prophylaxis. So, it is possible to continue prophylaxis program in hemophilia A patients with a cost-effective way in our country without risking the patient health. Moreover, Emicizumab prophylaxis reduces the chance of developing inhibitor to Factor VIII and it is convenient for administration due to less frequent and subcutaneous administration. 20 severe hemophilia A patients will be selected randomly from interested patients for this study. 6 patients with inhibitor will be randomized in Low dose Emicizumab with Inhibitor group (I) and rest 14 will be randomized by block randomization in Low dose Emicizumab (without inhibitor-WI) and low dose Factor VIII group at 4:10 ratio. Initial loading dose will be given and the participants will be followed up for 6 months. At the end of the study Annualized bleeding rate (ABR), Annualized joint bleeding rate (AJBR), Annualized spontaneous bleeding rate (ASBR), APTT will be compared among the groups. Inhibitor to factor VIII will also be evaluated after six months in Factor VIII group.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06938659
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Emicizumab Injection
Trials testing the same drug.
- NCT04188639 — Emicizumab in Acquired Hemophilia A · Phase 2 · completed
Other recruiting trials for Hemophilia A
Currently open trials in the same condition.
- NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
- NCT07416604 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A · Phase 3 · recruiting
- NCT07523399 — Joint Health, Balance and Quality of Life in Adults With Hemophilia A · recruiting
- NCT06833983 — To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A · Phase 3 · recruiting
- NCT06579144 — Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A · Phase 1 · recruiting
Other Dhaka Medical College trials
Trials by the same sponsor.
- NCT07381426 — Ferric Citrate in Iron Deficiency Anemia During Pregnancy · Phase 3 · not yet recruiting
- NCT04527562 — Colchicine in Moderate Symptomatic COVID-19 Patients · NA · completed
- NCT04874792 — Clinical Characteristics of Deceased With COVID-19 · completed
- NCT04523831 — Clinical Trial of Ivermectin Plus Doxycycline for the Treatment of Confirmed Covid-19 Infection · Phase 3 · completed
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 NCT06938659 (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 Dhaka Medical College
- Last refreshed: 22 April 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/NCT06938659.
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