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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00228592




Registration number
NCT00228592
Ethics application status
Date submitted
27/09/2005
Date registered
29/09/2005
Date last updated
13/02/2007

Titles & IDs
Public title
HepeX-B in Post Hepatic Allografts for Treatment of End Stage Liver Disease Due to Hepatitis B Infection
Scientific title
A Phase II, Multicenter, Randomized, Open-Label, Dose-Ranging, Parallel Group Study to Compare the Anti-Viral Effects, Pharmacokinetics and Safety of HepeX-Bä, a Mixture of Two Monoclonal Antibodies, as Compared to Hepatitis B Immune Globulin in Patients Who Have Received Hepatic Allografts for Treatment of End-Stage Liver Disease Due to Hepatitis B Virus Infection
Secondary ID [1] 0 0
HepeX-B 2003-12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 0 0
Liver Transplantation 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HepeX-B
Treatment: Drugs - Hepatitis B Immune Globulin (HBIg)

Treatment: Drugs: HepeX-B


Treatment: Drugs: Hepatitis B Immune Globulin (HBIg)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Male and female patients who are 18 years of age or older,

- Patients who are at least 6 months post first orthotopic liver transplantation (living
or cadaveric donor) for treatment of end-stage liver disease due to HBV infection,

- Patients who have received HBIg since transplantation and are on a stable regimen
(i.e., same dose and frequency) for at least the 3 months immediately preceding study
entry (Day 1),

- Patients who have received treatment with an inhibitor of HBV polymerase for at least
the 3 months immediately preceding study entry (Day 1),

- Patients with undetectable HBsAg and HBV DNA concentrations on two consecutive tests
at least 1 week apart during the screening period,

- Female patients who are of childbearing potential, and males whose partners are women
of childbearing potential, are required to use adequate contraception, and

- Patients who are able to provide written informed consent.

- Patients who successfully complete the initial 20-week treatment in the core trial are
eligible for the 52-week extension phase.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women who are pregnant or breastfeeding,

- Patients who have received another organ transplant that requires immunosuppression,

- Patients who are co-infected with hepatitis delta virus (HDV), hepatitis C virus (HCV)
and/or human immunodeficiency virus (HIV),

- Patients with clinical conditions or diseases, which, in the judgment of the
investigator, would place the patient at undue risk, interfere with study
participation, or confound the results of the study, and/or

- Patients who have participated in clinical studies in the 3 months prior to study
entry.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Nebraska
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Israel
State/province [11] 0 0
Jerusalem
Country [12] 0 0
Israel
State/province [12] 0 0
Petach Tikva
Country [13] 0 0
Israel
State/province [13] 0 0
Tel Aviv
Country [14] 0 0
New Zealand
State/province [14] 0 0
Auckland
Country [15] 0 0
Spain
State/province [15] 0 0
Valencia
Country [16] 0 0
United Kingdom
State/province [16] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the use of HepeX-B versus HBIg, two anti-viral drugs,
in patients who have received liver transplants due to liver failure caused by Hepatitis B
infection. Patients will be evaluated over a 6 month to 1.5 year period to evaluate whether
or not the drugs prevent the Hepatitis B virus from infecting the new liver.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00228592
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vinod Rustgi, MD
Address 0 0
Metropolitan Liver Diseases/ Gastroenterology Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00228592