deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT05249374

Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects

A Randomized, Double-blind, Active Drug-controlled, Dose-escalation Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of r-HSA in Patients With Cirrhosis and Ascites

Sponsor: Protgen Ltd

Conditions Hepatic Ascites
Interventions Human serum albumin Recombinant Human Serum Albumin
Updated 5 times since 2022 Last updated: Mar 8, 2026 Started: Oct 14, 2021 Primary completion: May 16, 2022 Completion: May 16, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Hepatic Ascites, this trial is completed. The trial is conducted by Protgen Ltd and has accumulated 5 data snapshots since 2021. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Mar 2022 – ~Feb 2023 · 11 months · monthly snapshotRecruiting~Feb 2023 – ~Jul 2024 · 17 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Mar 2026 · 18 months · monthly snapshotCompleted~Mar 2026 – present · 5 months · monthly snapshotCompleted

Change History

5 versions recorded

  1. Mar 2026 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Mar 2026 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Feb 2023 — Jul 2024 [monthly]

    Completed PHASE1

    Status: Recruiting → Completed

  5. Mar 2022 — Feb 2023 [monthly]

    Recruiting PHASE1

    First recorded

Oct 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Protgen Ltd
Data source: Protgen Ltd

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations