Recombinant coagulation factor VIII(Chia Tai-Tianqing) NCT04060836…

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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

Unknown status

Recruitment status

not reported

Planned enrollment

2020-03-01

Primary-completion proxy

Executive view

NCT04060836 evaluates Recombinant coagulation factor VIII(Chia Tai-Tianqing) in Hemophilia A. The disclosed sponsor is Chia Tai Tianqing Pharmaceutical Group Co., Ltd., the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Pharmacokinetic parameters between test preparation and reference preparation, peak plasma concentration (Cmax), assessed over Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4..

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 NCT04060836 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 VIII(Chia Tai-Tianqing), while Company & Deal Intelligence MCP organization_fetch was queried for Chia Tai Tianqing Pharmaceutical Group Co., Ltd..

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
NCT04060836	Recombinant coagulation factor VIII(Chia Tai-Tianqing)	Phase 1 / Unknown status	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	China	Pharmacokinetic parameters between test preparation and reference preparation, peak plasma concentration (Cmax) Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h…	2020-03-01
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

NCT04060836 is a Phase 1, unknown status study with not reported planned participants. Allocation is Randomized, masking is None (Open Label), and the intervention model is Crossover Assignment.

The primary endpoint is “Pharmacokinetic parameters between test preparation and reference preparation, peak plasma concentration (Cmax)” over “Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4..” The retrieved endpoint description is: Cmax is the maximum plasma concentration of Recombinant Coagulation Factor VIII or metabolite(s)..

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 NCT04060836 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 VIII(Chia Tai-Tianqing) is indexed as Recombinant coagulation factor with F10 biology and a global stage of Approved. The asset profile lists Chia Tai Tianqing Pharmaceutical Group Co., Ltd. as an originator or developer.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is indexed in an unreported country with the website http://www.cttq.com. Manufactures pharmaceutical products The record lists 147 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 VIII(Chia Tai-Tianqing) 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: NCT04060836
Protocol source: https://clinicaltrials.gov/study/NCT04060836
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 VIII(Chia Tai-Tianqing) in Hemophilia A is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Pharmacokinetic parameters between test preparation and reference preparation, peak plasma concentration (Cmax) and 2020-03-01 the leading decision points.

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