Last reviewed · How we verify
NCT01875874
An Open-Label, Multicenter, Historically-Controlled Study to Assess Safety and Efficacy of ELAD in Subjects With Acute Liver Failure (ALF)
Phase 2 trial testing ELAD in Acute Liver Failure in 8 participants. Terminated before completion.
1 September 2015
Quick facts
| Lead sponsor | Vital Therapies, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 1 October 2014 |
| Primary completion | 1 September 2015 |
| Estimated completion | 1 September 2018 |
| Sites | 18 locations across United States |
Drugs / interventions tested
- ELAD — full drug profile →
Conditions studied
- Acute Liver Failure — all drugs for Acute Liver Failure →
- Fulminant Hepatic Failure — all drugs for Fulminant Hepatic Failure →
- Primary Graft Non-Function — all drugs for Primary Graft Non-Function →
- Surgically-Induced Liver Failure — all drugs for Surgically-Induced Liver Failure →
Sponsor
Vital Therapies, Inc. — full company profile →
Who can join
18 and older, any sex, with Acute Liver Failure or Fulminant Hepatic Failure. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Overall Survival (OS) of ALF Subjects
Time frame: Study Day 1 through Study Day 28
Sponsor's own description
This phase 2 study is developed to evaluate the effect of ELAD on overall survival (OS) in subjects with acute liver failure (ALF) compared to matched historical controls.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01875874
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Liver Failure
Currently open trials in the same condition.
- NCT06831643 — Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure · NA · recruiting
- NCT06872372 — Role of N-Acetylcysteine in Non-Acetaminophen-Induced Acute Liver Failure · NA · active not recruiting
- NCT07329036 — ALSS - DPMAS and Therapeutic Plasma Exchange (TPE), Its Effect on Primary Coagulation, Inflammation and the Function of · NA · recruiting
- NCT05689645 — F573 for Injection for the Treatment of Liver Injury/Failure · Phase 2 · recruiting
- NCT05413083 — Evaluation of Cardiac Function in Acutely Decompensated Cirrhosis · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01875874 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vital Therapies, Inc.
- Last refreshed: 22 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01875874.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing