Hepatitis BPhase 2NCT00228592
HepeX-B in Post Hepatic Allografts for Treatment of End Stage Liver Disease Due to Hepatitis B Infection
A Phase 2 study testing HepeX-B and Hepatitis B Immune Globulin (HBIg) in people with Hepatitis B and Liver Transplantation, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 20 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Liver Transplantation
- What is being tested?
- HepeX-B and Hepatitis B Immune Globulin (HBIg)
- How many people
- Not given
- Where
- 20 sitesin 7 countries
- Study dates
- Start not givento Aug 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 7 countries.
20 sites in 7 countries
United States12 sites
University of North Carolina
Chapel Hill, North Carolina
University of Virginia
Charlottesville, Virginia
University of Cincinnati Medical Center
Cincinnati, Ohio
Metropolitan Liver Diseases/Gastroenterology Center
Fairfax, Virginia
UCLA
Los Angeles, California
Mt. Sinai
New York, New York
University of Nebraska
Omaha, Nebraska
University of Pennsylvania Health System
Philadelphia, Pennsylvania
Virginia Commonwealth University Health System
Richmond, Virginia
Mayo Clinic
Rochester, Minnesota
California Pacific Medical Center
San Francisco, California
UCSF
San Francisco, California
Israel3 sites
Hadassah University Hospital
Jerusalem
Rabin Medical Center
Petah Tikva
Tel-Aviv Sourasky Medical Center
Tel Aviv
Germany1 site
Humbolt University Virchow Clinic Dept. Viceral and Transplant Surgery
Berlin
About this study
Official 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
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.
- Conditions
- Hepatitis B, Liver Transplantation
- Being tested
- HepeX-B, Hepatitis B Immune Globulin (HBIg)
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepeX-BDrug
Hepatitis B Immune Globulin (HBIg)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Vinod Rustgi, MD, Principal investigator, Metropolitan Liver Diseases/ Gastroenterology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228592
- Sponsor's protocol ID
- HepeX-B 2003-12
- Status last verified
- Feb 2007
- First submitted
- 27 Sep 2005
- Last updated
- 13 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00228592
- Acronym / sponsor ID
- HepeX-B 2003-12
- Conditions
- Hepatitis B, Liver Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study completion
- Aug 2005
- First posted
- 29 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepeX-B | Drug | – |
| Hepatitis B Immune Globulin (HBIg) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinod Rustgi, MD principal investigator
Metropolitan Liver Diseases/ Gastroenterology Center
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HepeX-B and Hepatitis B Immune Globulin (HBIg) in people with Hepatitis B and Liver Transplantation, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 20 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Israel, France, Germany, New Zealand and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2007.