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Specific anti-hepatitis B immunoglobulin

Phase 3

Hepatitis B, Chronic | Small molecule | Infectious Disease |Grifols, S.A.|Last Updated: Feb 6, 2009

Target and mechanism

ModalitySmall molecule

Also known as Specific intravenous anti-hepatitis B immunoglobulin

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Specific anti-hepatitis B immunoglobulin · 1 trial · 1 indication

Phase 3 1
NCT00838071Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver TransplantationHepatitis B, Chronic
COMPLETED20 Analytics
PHASE3COMPLETED
Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation
Hepatitis B, Chronic
NCT0083807120
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
IGIV-HB GrifolsEXPERIMENTAL -

Interventions

NameTypeDescription
Specific intravenous anti-hepatitis B immunoglobulinDRUGMonthly doses of 5000 IU administered intravenously during 6 consecutive months
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. 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. 2. Patients who have required treatment with HBIG, or are receiving it at present. 3. Patie...

Countries:Spain
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