NCT01785082 is a Phase 3 clinical trial of 13-C-Methacetin in Liver Failure, sponsored by Humedics GmbH.

Who is sponsoring NCT01785082?

NCT01785082 is sponsored by Humedics GmbH.

What drugs are being tested in NCT01785082?

Interventions in NCT01785082: 13-C-Methacetin.

What condition does NCT01785082 study?

NCT01785082 studies Liver Failure.

Is NCT01785082 still recruiting?

NCT01785082 is currently completed. Last updated 23 October 2018.

Last reviewed 2018-10-23 · How we verify

NCT01785082

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Prospective, Randomized, Controlled, Multi-centric, Phase III Study for the Early Identification of Low-risk Patients After Partial Liver Resection by the LiMAx-test

Completed Phase 3 Last updated 23 October 2018

What this trial tests

Phase 3 trial testing 13-C-Methacetin in Liver Failure in 149 participants. Completed in 1 September 2015.

Timeline

1 January 2013

Primary endpoint
1 September 2015

1 September 2015

Quick facts

Lead sponsor	Humedics GmbH
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	149
Start date	1 January 2013
Primary completion	1 September 2015
Estimated completion	1 September 2015
Sites	4 locations across Germany

Drugs / interventions tested

13-C-Methacetin — full drug profile →

Conditions studied

Liver Failure — all drugs for Liver Failure →

Sponsor

Humedics GmbH — full company profile →

Who can join

18 and older, any sex, with Liver 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.

number of correctly determined positive patients in each trial group
Time frame: no later than day 30 after surgery
Correctly determined positive patients are patients which are transferred to general ward after surgery because of the result of the LiMAx-test (LiMAx-group) or general diagnosis (control group). Patients have to stay at general ward until discharge no later than day 30 after surgery.

Sponsor's own description

The purpose of this study is to investigate safety and efficacy of intravenously injected 0.4% 13-C-Methacetin solution for the determination of liver function with the LiMAx-test on patients with partial liver resection. The LiMAx-test is compared with an untreated control group and post-surgical management of both groups is investigated.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Randomized clinical trial comparing liver resection with and without perioperative assessment of liver function.
Stockmann M, Vondran FWR, Fahrner R, Tautenhahn HM, et al · · 2018 · cited 17× · PMID 30263981 · DOI 10.1002/bjs5.81
Spanish translation section
· 2018

Verify or expand the search:

Other recruiting trials for Liver Failure

Currently open trials in the same condition.

NCT07312864 — Safety and Tolerability Study of a Novel Bioartificial Liver in Liver Failure and Small-for-Size Syndrome · Phase 1, PHASE2 · recruiting
NCT06871111 — The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) Trial · Phase 1 · recruiting
NCT07053488 — CRISPR-Edited HLA Donor Liver Transplant to Reduce Rejection · Phase 1, PHASE2 · recruiting
NCT06908746 — Efficacy and Safety of Citrate Anticoagulation in CRRT for Patients With Liver Failure/DysfuncTION, the CAUTION Trial! A · recruiting
NCT06224023 — Predictive Values of Presepsin Levels in ASciteS in Patients With Chronic Liver Failure · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01785082 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Humedics GmbH
Last refreshed: 23 October 2018

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/NCT01785082.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing