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intramuscular hepatitis B virus immune globulin

Phase 2

Hepatitis B, Chronic | Small molecule | Infectious Disease |Grifols, S.A.|Last Updated: May 8, 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

intramuscular hepatitis B virus immune globulin · 1 trial · 1 indication

Phase 2 1
NCT00895713Efficacy and Safety of Intramuscular HBIG Grifols for the Prevention of Recurrence After Liver TransplantationHepatitis B, Chronic
COMPLETED18 Analytics
PHASE2COMPLETED
Efficacy and Safety of Intramuscular HBIG Grifols for the Prevention of Recurrence After Liver Transplantation
Hepatitis B, Chronic
NCT0089571318
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Study Endpoints

Primary Endpoints

Mean trough serum HBsAg Ab titer
Months 4-6

Secondary Endpoints

HBV recurrence percentage in long-term OLT recipients during i.m. HBIG Grifols treatment period
Week 2 - 7 months
Mean trough HBsAg Ab titer
4 months
Individualised trough HBsAg Ab titer
Week 2 - 7 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
im HBIG GrifolsEXPERIMENTAL -

Interventions

NameTypeDescription
intramuscular hepatitis B virus immune globulinDRUGBiweekly intramuscular doses of 2000 IU administered during 6 consecutive months
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Male or female. 2. Age \> 18 years and \< 70 years. 3. OLT recipient for HBV infection-related disease for \> 18 months before inclusion in the clinical trial. 4. Serum HBsAg-positive within 3 months before transplantation. 5. Serum HBsAg-negative just before inclusion in the...

Countries:Italy
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Frequently asked questions about intramuscular hepatitis B virus immune globulin

What is intramuscular hepatitis B virus immune globulin used for?

Intramuscular hepatitis B virus immune globulin is used for chronic hepatitis B, specifically to prevent recurrence of the infection after liver transplantation. It is an investigational therapy being developed by Grifols, S.A. and is currently in Phase 2 clinical development.

Who makes intramuscular hepatitis B virus immune globulin?

Grifols, S.A. (ticker: GRFS) is developing intramuscular hepatitis B virus immune globulin. The company is conducting clinical trials to evaluate its efficacy and safety for preventing recurrence of chronic hepatitis B after liver transplantation.

What phase is intramuscular hepatitis B virus immune globulin in?

Intramuscular hepatitis B virus immune globulin is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed to assess its use in preventing hepatitis B recurrence after liver transplantation.

What clinical trials is intramuscular hepatitis B virus immune globulin in?

Intramuscular hepatitis B virus immune globulin has one completed Phase 2 trial, NCT00895713, titled 'Efficacy and Safety of Intramuscular HBIG Grifols for the Prevention of Recurrence After Liver Transplantation.' The trial enrolled 18 participants with chronic hepatitis B in Italy and was not randomized or blinded.

How does intramuscular hepatitis B virus immune globulin work?

Intramuscular hepatitis B virus immune globulin is a small molecule therapy. It is designed to provide passive immunity against hepatitis B virus, helping to prevent recurrence of infection in patients who have undergone liver transplantation for chronic hepatitis B.