Back to resultsNabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation (Nabi-HB-SC)
Primary Purpose
Hepatitis B, Chronic
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Nabi-HB
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Chronic hepatitis B liver disease
Eligibility Criteria
Inclusion Criteria:
- Male or female patients 18 years old or older as of visit one.
- If female is not trying to conserve, not lactating, and has a negative serum pregnancy test and use an acceptable method of contraception or be at least one year post-menopausal or surgically sterile.
- Able to provide written informed consent.
- First time liver transplant recipient.
- Primary, single organ recipient (deceased donor <65 years old).
- receive regular long-term HBIG prophylaxis with stabilized HBIG dosage and administration intervals.
- Have negative quantifiable HBV-DNA and HBsAg results prior to dosing at visit 2.
- Following the last IV administration of HBIG, have a baseline serum anti-HBs level of >150 IU/ML prior to dosing at visit 2.
Exclusion Criteria
- Positive HCV or HIV test results.
- Unexplained elevated liver function tests.
- Serum creatinine level >2.0 times the upper limit of normal.
- life expectancy <6 months.
- liver transplantation with ongoing acute rejection episode. Donor liver that was from a hepatitis Bor C positive donor. Underwent a liver transplant <12 months prior to visit 1.
- Know history of cancer, suspected cancer, or cancer therapy within 12 months.
- History of autoimmune disease.
- History/current evidence of coagulation disorder, severe cardiac disease, unhealed gastric or duodenal ulcer, or other significant disease.
- Evidence of any other unresolved infection and any unresolved opportunistic infection requiring treatment.
- Known immunoglobulin A deficiency.
- History of use of immunosupressive or immunomodulatory drug within 3 month prior to visit 1. (except low dose glucocorticoid therapy, <10 mg of prednisone or equivalent per day.)
- received and investigational drug 30 days prior to visit 1.
- use of plasma preparations or other immunoglobulins during the study.
- Know intolerance to proteins of human origin, immunoglobulin, or comparable products.
- Evidence of alcohol and/or drug abuse within 6 month of visit 2 or inability/unwillingness to abstain from alcohol for the duration of the study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm One: Nabi-HB
Arm Description
All subjects will be administered Nabi HB Subcutaneously
Outcomes
Primary Outcome Measures
To evaluate the efficacy of Nabi-HB administered subcutaneously weekly for a total of 14 weeks in patients who previously underwent a liver transplant. Levels will provide evidence if effective anti-HB levels >150 IU/ML can be maintained.
Secondary Outcome Measures
To evaluate the safety of Nabi-HB administered subcutaneously weekly for a total of 14 weeks.
Full Information
NCT ID
NCT00800787
First Posted
November 26, 2008
Last Updated
January 15, 2016
Sponsor
Biotest Pharmaceuticals Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00800787
Brief Title
Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation
Acronym
Nabi-HB-SC
Official Title
A Phase 3, Multicenter, Open Label Study to Assess the Safety and Efficacy of Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Associated Liver Disease Who Underwent Liver Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Withdrawn
Why Stopped
New sponsor's existing product under evaluation for this indication
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotest Pharmaceuticals Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A phase 3, multicenter, open label study to assess the safety and efficacy of Nabi-HB, administered subcutaneously in patients with Hepatitis B Virus Associated Liver Disease who underwent liver transplantation.
Detailed Description
This is a phase 3 prospective, single arm open label study to be conducted t approximately 4 study sited located in th e USA. Approximately 25 HBV DNA negative patients who underwent liver transplant at least one year prior, due to chronic hepatitis B infection will bwe eligible for study participation. The study consist of a total of 16 study visit and the duration of participation will be 20 weeks for each patients. Patients will be converted from the intravenous standard HBIG to Nabi-HB subcutaneous administration according to the individual scheduled dosing interval.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Chronic hepatitis B liver disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm One: Nabi-HB
Arm Type
Experimental
Arm Description
All subjects will be administered Nabi HB Subcutaneously
Intervention Type
Biological
Intervention Name(s)
Nabi-HB
Other Intervention Name(s)
Hepatitis B Immune Globulin (Human)
Intervention Description
Hepatitis b Immune Globulin (Human)(Nabi-HB) 312 IU/L per dose administered subcutaneously.
Dosage will be according to each patients body weight, as follow:
< 75 kg: 500 IU weekly ( may be increase to 1,000 IU weekly if anti-HBs levels are <150 IU/ML > 75 Kg: 1,000 IU weekly
Primary Outcome Measure Information:
Title
To evaluate the efficacy of Nabi-HB administered subcutaneously weekly for a total of 14 weeks in patients who previously underwent a liver transplant. Levels will provide evidence if effective anti-HB levels >150 IU/ML can be maintained.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
To evaluate the safety of Nabi-HB administered subcutaneously weekly for a total of 14 weeks.
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients 18 years old or older as of visit one.
If female is not trying to conserve, not lactating, and has a negative serum pregnancy test and use an acceptable method of contraception or be at least one year post-menopausal or surgically sterile.
Able to provide written informed consent.
First time liver transplant recipient.
Primary, single organ recipient (deceased donor <65 years old).
receive regular long-term HBIG prophylaxis with stabilized HBIG dosage and administration intervals.
Have negative quantifiable HBV-DNA and HBsAg results prior to dosing at visit 2.
Following the last IV administration of HBIG, have a baseline serum anti-HBs level of >150 IU/ML prior to dosing at visit 2.
Exclusion Criteria
Positive HCV or HIV test results.
Unexplained elevated liver function tests.
Serum creatinine level >2.0 times the upper limit of normal.
life expectancy <6 months.
liver transplantation with ongoing acute rejection episode. Donor liver that was from a hepatitis Bor C positive donor. Underwent a liver transplant <12 months prior to visit 1.
Know history of cancer, suspected cancer, or cancer therapy within 12 months.
History of autoimmune disease.
History/current evidence of coagulation disorder, severe cardiac disease, unhealed gastric or duodenal ulcer, or other significant disease.
Evidence of any other unresolved infection and any unresolved opportunistic infection requiring treatment.
Known immunoglobulin A deficiency.
History of use of immunosupressive or immunomodulatory drug within 3 month prior to visit 1. (except low dose glucocorticoid therapy, <10 mg of prednisone or equivalent per day.)
received and investigational drug 30 days prior to visit 1.
use of plasma preparations or other immunoglobulins during the study.
Know intolerance to proteins of human origin, immunoglobulin, or comparable products.
Evidence of alcohol and/or drug abuse within 6 month of visit 2 or inability/unwillingness to abstain from alcohol for the duration of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shailesh Chavan, MD
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation
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