Recombinant Coagulation Factor VIIa(rEVO Biologics) in Hemophilia A: ACTRN12620001152910 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: 16 October 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Completed
Recruitment status
not reported
Planned enrollment
2021-08-27
Primary-completion proxy
Executive view
ACTRN12620001152910 evaluates Recombinant Coagulation Factor VIIa(rEVO Biologics) in Hemophilia A. The disclosed sponsor is LFB USA, Inc., the design is Interventional, and the geographic footprint is New Zealand, South Africa, Ukraine. 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 ACTRN12620001152910 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 Recombinant Coagulation Factor VIIa(rEVO Biologics), while Company & Deal Intelligence MCP organization_fetch was queried for LFB USA, Inc..
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 |
|---|---|---|---|---|---|---|
| ACTRN12620001152910 | Recombinant Coagulation Factor VIIa(rEVO Biologics) | Phase 1 / Completed | LFB USA, Inc. | New Zealand, South Africa, Ukraine | 2021-08-27 | |
| NCT05441553 | VGB-R04 | Phase 1/2 / Unknown status | Shanghai Vitalgen Biopharma Co., Ltd. | China | Incidence of adverse events Baseline up to Week 52 | 2025-01-01 |
| NCT05421429 | Armocibart | Phase 2 / Completed | Suzhou Alphamab Co., Ltd. | China | Frequency and severity of treatment emergent adverse events(TEAEs) Day 1 up to Day 85 | 2024-01-17 |
| NCT05365217 | Nonacog beta pegol | Phase 3 / Completed | Novo Nordisk A/S | China | Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes During on Demand and Prophylaxis… From start of treatment (week 0) until end of treatment (up to week 5… | 2024-04-11 |
| NCT05306418 | Denecimig | Phase 3 / Completed | Novo Nordisk A/S | United States, Japan, United Kingdom, Switzerland, Portugal, Spain, Russia, India, Canada, South Korea, Netherlands, China, Taiwan Province, Poland, South Africa, Italy, Israel, Lithuania, Germany | Number of treatment emergent adverse events From treatment initiation to follow up visit (week 0 to week 72) | 2024-11-13 |
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
ACTRN12620001152910 is a Phase 1, completed study with not reported planned participants. Allocation is Randomised controlled trial, masking is Open (masking not used), and the intervention model is not reported.
The primary endpoint is “not reported” over “not reported.” The retrieved endpoint description is: The primary objective of this study is to evaluate the single-dose PK of LR769 at 75 and 225 µg/kg in subjects with hemophilia A, with and without inhibitors to FVIII. FVIIa concentrations will be determined using a validated activity assay. Noncompartmental and compartmental PK analysis will be performed, and the following PK parameters will be calculated: - Maximum plasma concentration (Cmax) - Area under the plasma concentration-time curve from Time 0 (dosing) to the time of the last measurable concentration (AUC0-last) - Area under the plasma concentration-time curve from Time 0 (dosing) extrapolated to infi….
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 not reported 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
0 recent result records were selected as contextual evidence for Hemophilia A. These records do not establish direct evidence for ACTRN12620001152910 unless the registration number matches.
Indexed evidence status
No directly comparable result record was retrieved for this disease query. This is a monitoring gap, not evidence of absence.
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
Recombinant Coagulation Factor VIIa(rEVO Biologics) is indexed as Recombinant coagulation factor with target not reported biology and a global stage of Pending. The asset profile lists rEVO Biologics, Inc. as an originator or developer.
LFB USA, Inc. is indexed in an unreported country with the website http://www.lfb-usa.com. LFB USA is a biotechnology company in the Boston, Massachusetts. The record lists 1 development-stage drug assets.
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 Recombinant Coagulation Factor VIIa(rEVO Biologics) 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: ACTRN12620001152910
Protocol source: https://anzctr.org.au/ACTRN12620001152910.aspx
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: 16 October 2026.
Recombinant Coagulation Factor VIIa(rEVO Biologics) 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 2021-08-27 the leading decision points.
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