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Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis

Study acronym: Cellgram-LC
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 3 months later Aug 2, 2027 → Dec 1, 2029
See other at-risk trials from Pharmicell Co., Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 2, 2027 to Dec 1, 2029 Show 7 more changesShow less
    • Start date: Mar 2, 2021 to Apr 19, 2021
    • Trial sites expanded: 11 → 15 locations
    • Study completion pushed from Jan 2, 2028 to Dec 1, 2029
    • Interventions modified
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: details revised at 7 of 8 entries
    • Study description shortened, about 21 words
  2. Primary completion date: Mar 2, 2026 to Aug 2, 2027
    • Study completion date: Mar 2, 2026 to Jan 2, 2028
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Mar 2, 2021 to Mar 2, 2026
    • Study sites: 10 to 11
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to evaluate the efficacy and safety of Cellgram-LC in patients with alcoholic cirrhosis. The main questions it aims to answer are: * Is Cellgram-LC superior to best supportive care (BSC) in patients with alcoholic cirrhosis? * What medical problems do participants have after receiving Cellgram-LC compared with BSC? Participants will: * Receive a single dose of Cellgram-LC at Week 0 or receive best supportive care according to their assigned study group. * Attend clinic visits for scheduled assessments at Week 4 and Months 3, 6, 9, 12, 18, and 24. * Complete scheduled telephone follow-up at Months 2, 4, 5, 7, 8, 10, 11, 15, 21, 27, 30, 33, and 36. * Be followed for transplant-free survival and other study outcomes.
Trial Details
NCT Number NCT04689152
Lead Sponsor Pharmicell Co., Ltd.
Conditions
(from sponsor)		 Alcoholic Cirrhosis
Related terms Liver Cirrhosis, Liver Cirrhosis, Alcoholic
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov