NCT00838071

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

9 months

First QC Date

February 5, 2009

Last Update Submit

February 5, 2009

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis BHBVAnti-hepatitis B antibodiesImmunoglobulinsliver transplantationProtective levelsRecurrenceIntravenous

Outcome Measures

Primary Outcomes (1)

  • 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.

    At months 4, 5, and 6

Secondary Outcomes (5)

  • To determine the in vivo recovery of 6 consecutive doses of HB-IVIG Grifols and demonstrate that it remains constant for each dose.

    At months 1, 2, 3, 4, 5, and 6

  • To determine various pharmacokinetic parameters after 6 administrations of HB-IVIG Grifols

    At months 1, 2, 3, 4, 5, and 6

  • To determine the incidence of recurrences during the treatment

    At months 1, 2, 3, 4, 5, and 6

  • To evaluate tolerance to the administration of HB-IVIG Grifols

    At months 1, 2, 3, 4, 5, and 6

  • To confirm the viral safety of the product supervising viral markers

    At months 1, 2, 3, 4, 5, and 6

Study Arms (1)

IGIV-HB Grifols

EXPERIMENTAL
Drug: Specific intravenous anti-hepatitis B immunoglobulin

Interventions

Specific intravenous anti-hepatitis B immunoglobulinDRUG

Monthly doses of 5000 IU administered intravenously during 6 consecutive months

Also known as: Niuliva
IGIV-HB Grifols

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08035, Spain

Location

Hospital Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis BRecurrence

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Antoni Mas, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 6, 2009

Study Start

October 1, 2003

Primary Completion

July 1, 2004

Study Completion

August 1, 2004

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations

ES(4)