Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation
This study has been completed.
Sponsor:
Instituto Grifols, S.A.
Information provided by:
Grifols Biologicals Inc.
ClinicalTrials.gov Identifier:
NCT00838071
First received: February 5, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine whether protective anti-HB serum levels are maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific hepatitis B immune globulin, in patients having previously undergone liver transplantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B, Chronic |
Drug: Specific intravenous anti-hepatitis B immunoglobulin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Evaluation of Anti-Hepatitis B Antibodies Levels in Serum After the Intravenous Administration of Specific Anti-Hepatitis B Immunoglobulin (IGIV-HB Grifols) in Patients Having Previously Undergone Liver Transplantation |
Resource links provided by NLM:
Drug Information available for:
Recombinant Hepatitis B vaccine
Hepatitis B immunoglobulins
Hepatitis A Vaccines
U.S. FDA Resources
Further study details as provided by Grifols Biologicals Inc.:
Primary Outcome Measures:
- To determine if after 4 months of continuous monthly administration of HB-IVIG Grifols, the anti-hepatitis B antibodies contained in the product reach levels considered as protective, and to assess if these levels are kept constant during 2 more months. [ Time Frame: At months 4, 5, and 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine the in vivo recovery of 6 consecutive doses of HB-IVIG Grifols and demonstrate that it remains constant for each dose. [ Time Frame: At months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
- To determine various pharmacokinetic parameters after 6 administrations of HB-IVIG Grifols [ Time Frame: At months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
- To determine the incidence of recurrences during the treatment [ Time Frame: At months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
- To evaluate tolerance to the administration of HB-IVIG Grifols [ Time Frame: At months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: Yes ]
- To confirm the viral safety of the product supervising viral markers [ Time Frame: At months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: Yes ]
| Enrollment: | 20 |
| Study Start Date: | October 2003 |
| Study Completion Date: | August 2004 |
| Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: IGIV-HB Grifols |
Drug: Specific intravenous anti-hepatitis B immunoglobulin
Monthly doses of 5000 IU administered intravenously during 6 consecutive months
Other Name: Niuliva
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients having undergone a liver transplantation due to liver disease associated with hepatitis B virus, at least 1 year before and no more than 5 years before inclusion in the study.
- Patients who have required treatment with HBIG, or are receiving it at present.
- Patients from 18 to 70 years of age.
- The patient agrees to participate and comply with all aspects of the protocol, including the planned blood sample collection, and has signed the informed consent form.
Exclusion Criteria:
- Presence of HBV DNA or HBeAg indicating virus replication.
- Patients with known allergies to some component of HB-IVIG, such as sorbitol (e.g. patients presenting intolerance to fructose).
- Patients with a known background of severe or frequent reactions to products derived from plasma.
- Patients presenting arterial hypertension that is not clinically controlled.
- Patients presenting a creatinine value >2 mg/dl, nephrotic syndrome or renal failure.
- Patients presenting anaemia (haemoglobin < 11 g/dl).
- Patients being treated with interferon.
- The patient suffers some acute or chronic medical condition that the investigator believes may interfere with the development or interpretation of the study.
- The patient is known to abuse of alcohol, opiates, psychotropic agents or other drugs or chemical substances; or has done so in the past 12 months.
- Pregnant women at the time of inclusion or that may be pregnant in the next 7 months or breast-feeding women.
- Patients participating in another clinical study, or who have received another investigational product in the last 3 months.
- Possibility that the patient may be treated with other products containing immunoglobulins in a period of 7 months.
- Suspicion of conditions that may affect the patient's compliance, including an expected survival of less than 1 year.
- Any patient that does not have a frozen serum sample previous to the first study medication infusion.
- Patients with selective IgA deficiency.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838071
Locations
| Spain | |
| Hospital Clínic de Barcelona | |
| Barcelona, Spain, 08035 | |
| Hospital Vall d'Hebron | |
| Barcelona, Spain, 08035 | |
| Hospital Universitario 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital Virgen del Rocío | |
| Sevilla, Spain, 41013 | |
Sponsors and Collaborators
Instituto Grifols, S.A.
Investigators
| Principal Investigator: | Antoni Mas, MD | Hospital Clínic de Barcelona |
More Information
No publications provided
| Responsible Party: | Antonio Páez, MD, Instituto Grifols |
| ClinicalTrials.gov Identifier: | NCT00838071 History of Changes |
| Other Study ID Numbers: | IG301 |
| Study First Received: | February 5, 2009 |
| Last Updated: | February 5, 2009 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Grifols Biologicals Inc.:
|
Hepatitis B HBV Anti-hepatitis B antibodies Immunoglobulins |
liver transplantation Protective levels Recurrence Intravenous |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Hepatitis, Chronic Antibodies Hepatitis B Antibodies Immunoglobulins Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013