NCT01856413 (ZEUS) is a Phase 3 clinical trial of Zutectra in Hepatitis B, sponsored by Biotest.

Who is sponsoring NCT01856413?

NCT01856413 is sponsored by Biotest.

What drugs are being tested in NCT01856413?

Interventions in NCT01856413: Zutectra.

What condition does NCT01856413 study?

NCT01856413 studies Hepatitis B.

Is NCT01856413 still recruiting?

NCT01856413 is currently completed. Last updated 24 March 2015.

Last reviewed 2015-03-24 · How we verify

NCT01856413: ZEUS

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

An Open, Prospective, Single Arm Study Investigating Efficacy and Safety of Human Hepatitis B Immunoglobulin Zutectra in Liver Transplanted Patients - the ZEUS Study

Completed Phase 3 Last updated 24 March 2015

What this trial tests

Phase 3 trial testing Zutectra in Hepatitis B in 49 participants. Completed in 1 September 2014.

Timeline

1 December 2012

Primary endpoint
1 September 2014

1 September 2014

Quick facts

Lead sponsor	Biotest
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	49
Start date	1 December 2012
Primary completion	1 September 2014
Estimated completion	1 September 2014
Sites	16 locations across France, Italy, Spain, United Kingdom

Drugs / interventions tested

Zutectra — full drug profile →

Conditions studied

Hepatitis B — all drugs for Hepatitis B →

Sponsor

Biotest — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatitis B. 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.

Trough levels of serum anti-HBs antibody concentrations
Time frame: 24 weeks

Sponsor's own description

Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure require longterm therapy to prevent HBV reinfection of the transplanted liver. The approved preventative treatment is a combination of antihepatitis B immunoglobulin (HBIg) and oral antiviral medication. In the first 6 months after liver transplantation, patients receive treatment with intravenous HBIg to maintain blood antihepatitis B (antiHBs)antibody concentrations above 100 IU/L, the level considered safe for preventing hepatitis B reinfection. Zutectra is an HBIg preparation for subcutaneous injection that is approved in the EU for the 'prevention of HBV reinfection in HBV DNA negative patients ≥ 6 months after liver transplantation for hepatitis B induced liver failure'. The purpose of this study is to show that earlier subcutaneous HBIg treatment with Zutectra after liver transplantation can prevent hepatitis B reinfection. Treatment with subcutaneous HBIg (Zutectra) at home is manageable for the majority of patients and is more convenient for patients compared to intravenous treatment that must take place in the hospital setting. Fourty patients will take part in the study at approximately 19 centres in UK, France, Italy and Spain. Patients who are eligible for the study will receive treatment with Zutectra for 24 weeks. During the study, the safety and effectiveness of Zutectra will be assessed by checking for symptoms of hepatitis B related infection, as well as monitoring blood levels of antiHBs antibodies and hepatitis B surface antigen (HBsAg).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Hepatitis B

Currently open trials in the same condition.

NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B · Phase 1 · recruiting
NCT07168356 — A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease · Phase 1 · recruiting
NCT06947356 — Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads · NA · recruiting
NCT06537414 — A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living Wit · Phase 2 · active not recruiting
NCT06623071 — Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384 · recruiting

Other Biotest trials

Trials by the same sponsor.

NCT05722938 — Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) · Phase 3 · recruiting
NCT05531149 — Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia · Phase 3 · terminated
NCT05170269 — Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion) · Phase 3 · terminated
NCT04576728 — Efficacy and Safety of Trimodulin in Subjects With Severe COVID-19 · Phase 2 · completed
NCT03444324 — Adjusted Fibrinogen Replacement Strategy · Phase 3 · completed

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 NCT01856413 (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 Biotest
Last refreshed: 24 March 2015

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/NCT01856413.

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