Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07404891 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Primary completion date changed from estimate of Jul 31, 2026 to Sep 17, 2026 · Completion pushed from Dec 31, 2026 to Mar 31, 2027 · Eligibility criteria expanded, about 29 words · 2 more Show 5 more changesShow less
    • Primary completion date changed from estimate of Jul 31, 2026 to Sep 17, 2026
    • Completion pushed from Dec 31, 2026 to Mar 31, 2027
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  3. Start date: Jan 31, 2026 to Mar 18, 2026 Study sites: 0 to 1 · Secondary endpoints: 3 to 4v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Secondary endpoints: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This clinical trial will focus on the core efficacy endpoints including relief of pain intensity, improvement of joint motor function and enhancement of quality of life in patients. Meanwhile, it will strictly monitor key safety indicators such as the occurrence of various adverse events after medication, the severity and duration of adverse reactions, and conduct a multi-dimensional and multi-level comprehensive assessment. The study aims to clarify the clinical benefit profile and safety risks of the investigational product ALT001, and provide scientific, detailed and reliable evidence-based medical data to support the optimization of clinical treatment guidelines and the formulation of individualized treatment regimens for knee osteoarthritis. Patients enrolled in the trial will receive investigational product treatment on the basis of conventional therapy. They will be randomly assigned to the placebo group, low-dose group and high-dose group at a ratio of 1:1:1. For each treatment course, patients in all groups will receive an injection of 2 vials of the investigational product into a single knee joint (for bilateral knee osteoarthritis, both knees may be injected, with one fixed knee joint selected for subsequent assessments). The injection will be administered once every 2 weeks for a total of 6 administrations.
Trial Details
NCT Number NCT07404891
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Osteoarthritis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov