CTR20261330 UREA, C-14 Helicobacter pylori infection Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines CTR20261330 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 13 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why CTR20261330 is a hot trial to watch
Helicobacter pylori infection is being segmented by mechanism, treatment setting, geography and endpoint architecture. CTR20261330 is notable because it evaluates UREA, C-14 in a Phase 3 design sponsored by Shenzhen Freekang Biotechnology Co., Ltd.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | CTR20261330 |
| Official title | 尿素[14C]胶囊用于诊断 Hp 感染的随机、开放、交叉、自身对照、多中心临床研究 |
| Phase / status | Phase 3 / 已完成 |
| Intervention | UREA, C-14 |
| Sponsor | Shenzhen Freekang Biotechnology Co., Ltd. |
| Geography | China |
| Enrollment | [object Object] |
| Primary endpoint | |
| Endpoint time frame | 所有受试者出组后6个月内 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The indexed record describes a Phase 3 study of UREA, C-14 in Helicobacter pylori infection.
Allocation is 随机化, masking is 开放, and the intervention model is 交叉设计. Planned enrollment of [object Object] participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Primary endpoint (所有受试者出组后6个月内) — 灵敏度：比较受试制剂和参比制剂诊断幽门螺杆菌感染的灵敏度
- Primary endpoint (所有受试者出组后6个月内) — 特异度：比较受试制剂和参比制剂诊断幽门螺杆菌感染的特异度
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: UREA, C-14 is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Shenzhen Freekang Biotechnology Co., Ltd. is resolved to a normalized organization record in Shenzhen, China. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
CTR20261330 provides a focused lens on Helicobacter pylori infection development. Its value will be determined by whether UREA, C-14 can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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