Hepatitis B, ChronicPhase 3Nabi-HB-SCNCT00800787
Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation
A Phase 3 study testing Nabi-HB in people with Hepatitis B, Chronic, run by Biotest Pharmaceuticals Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Nabi-HB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Sep 2010
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Nabi-HB
- Keywords
- Chronic hepatitis B liver disease
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nabi-HBBiological
Also called Hepatitis B Immune Globulin (Human)
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
| Study group | Role | What they receive |
|---|---|---|
| Arm One: Nabi-HB | Experimental | All subjects will be administered Nabi HB Subcutaneously Receives: Biological: Nabi-HB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 weeks
Secondary outcomes (1)
To evaluate the safety of Nabi-HB administered subcutaneously weekly for a total of 14 weeks.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startApr 2010
- Primary completionAug 2010 (estimated)
- Study completionSep 2010 (estimated)
Why it stopped: New sponsor's existing product under evaluation for this indication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotest Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shailesh Chavan, MD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800787
- Sponsor's protocol ID
- 4210
- Acronym
- Nabi-HB-SC
- Status last verified
- Jun 2010
- First submitted
- 26 Nov 2008
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00800787
- Acronym / sponsor ID
- Nabi-HB-SC / 4210
- Conditions
- Hepatitis B, Chronic
- Keywords
- Chronic hepatitis B liver disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: New sponsor's existing product under evaluation for this indication
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biotest Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 2 Dec 2008 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm One: Nabi-HB | Experimental | Biological: Nabi-HBAll subjects will be administered Nabi HB Subcutaneously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| Nabi-HBAlso: Hepatitis B Immune Globulin (Human)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 | Biological | Arm One: Nabi-HB |
Primary outcome
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
1 secondary outcome
To evaluate the safety of Nabi-HB administered subcutaneously weekly for a total of 14 weeks.
Time frame: 14 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
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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.
Shailesh Chavan, MD study director
Sponsor GmbH
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nabi-HB in people with Hepatitis B, Chronic, run by Biotest Pharmaceuticals Corporation.
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 15 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: withdrawn, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
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 18 Jan 2016.