Emicizumab in Hemophilia A: CTRI/2024/01/061593 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 4
Clinical phase
Completed
Recruitment status
30
Planned enrollment
2026-05-27
Primary-completion proxy
Executive view
CTRI/2024/01/061593 evaluates Emicizumab in Hemophilia A. The disclosed sponsor is Sponsor not reported, the design is Interventional, and the geographic footprint is India. The first listed primary endpoint is not reported, assessed over an unreported time frame.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for CTRI/2024/01/061593 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Hemophilia A landscape. Drug & Asset MCP drug_fetch was queried for Emicizumab, while Company & Deal Intelligence MCP organization_fetch was queried for Sponsor not reported.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| CTRI/2024/01/061593 | Emicizumab | Phase 4 / Completed | Sponsor not reported | India | 2026-05-27 | |
| NCT06238908 | NGGT-003 | Early Phase 1 / Recruiting | Suzhou Nuojiebei Biotechnology Co., Ltd. | China | Adverse events (AEs) and serious adverse events (SAEs) 52 weeks | 2026-01-31 |
| NCT06224907 | Valoctocogene roxaparvovec | Phase 3 / Active, not recruiting | BioMarin Pharmaceutical, Inc. | Japan | Change in the human coagulation factor VIII (hFVIII) activity, as measured by chromogenic substrate assay, during Weeks… 52 Weeks | 2025-04-16 |
| NCT06155955 | Emicizumab | Phase 2/3 / Unknown status | Sponsor not reported | Thailand | spontaneous and traumatic bleeding rate 6 months after start low dose emicizumab as secondary prophylaxis tre… | 2024-03-21 |
| NCT06145373 | Emicizumab | Phase 4 / Recruiting | Sanofi | United States, Taiwan Province | Number of participants with Adverse events (AEs) during the fitusiran treatment From Day 1 up to Month 4 | 2028-05-28 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
CTRI/2024/01/061593 is a Phase 4, completed study with 30 planned participants. Allocation is not reported, masking is not reported, and the intervention model is not reported.
The primary endpoint is “not reported” over “not reported.” The retrieved endpoint description is: Annual Bleed Rate, Annual Joint Bleed Rate, target joint and laboratory dataTimepoint: 9 months prior starting low or standard dose emicizumab, baseline and during emicizumab prophylaxis: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks. Post emicizumab prophylaxis: 4 weeks.
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 30 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Hemophilia A. These records do not establish direct evidence for CTRI/2024/01/061593 unless the registration number matches.
Cardiovascular risk and disease in haemophilia a patients: the comor-HA cohort study
Not Applicable; n=105; Arterial hypertension = 70.4 % Source: https://esc365.escardio.org/presentation/330994
A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inh…
Phase 3; n=2; No numerical result field reported Source: https://clinicaltrials.gov/ct2/show/results/NCT05695391
Comparative effectiveness of standard and lower dose emicizumab prophylaxis across age groups in severe hemophilia A: Multi-center data from India
Not Applicable; n=703; AE = There were no thrombotic events, and adverse events were rare and mild ; AE = There were no thrombotic events, and adverse events were rare and mild Source: https://academy.isth.org/isth/2026/isth-congress/4226219/rucha.patil.comparative.effectiveness.of.standard.and.lower.dose.emicizumab.html?f=menu%3D6%2Abrowseby%3D8%2Asortby%3D2%2Ace_id%3D3079%2Aot_id%3D116680%2Amarker%3D6727
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Emicizumab is indexed as Bispecific antibody with F10 x factor IXa biology and a global stage of Approved. The asset profile lists Chugai Pharmaceutical Co., Ltd. as an originator or developer.
No exact Company & Deal Intelligence profile was returned for Sponsor not reported. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Emicizumab is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: CTRI/2024/01/061593
Protocol source: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=97535
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 28 September 2026.
Emicizumab in Hemophilia A is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes the primary endpoint and 2026-05-27 the leading decision points.
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