A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients

S

SK chemicals

Status and phase

Completed
Phase 3

Conditions

Hepatitis B

Treatments

Drug: Hepabulin IV

Study type

Interventional

Funder types

Industry

Identifiers

NCT01513850
Hepabulin IV_LT_lll_2011

Details and patient eligibility

About

The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.

Full description

A 52-week, Multi-center, Open label, Single arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg positive Liver Transplantation recipients

Enrollment

87 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • HBsAg Positive candidate for HBV-related liver transplant
  • Primary, single organ recipients
  • written informed consent

Exclusion criteria

  • acute renal failure, Serum creatinin >1.5*ULN
  • severe cardiac disease or other significant disease
  • HAV, HCV or HIV positive
  • Immunoglobulin A deficiency.
  • History of hypersensitivity to Human Immunoglobulin.
  • History of cancer within 5 years. (without HCC)
  • History of alcohol or/and drug abuse.
  • History organ transplantation.
  • Within 30 days, participation in another clinical trial and use of an investigational product.
  • Subject suffer from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that, may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of study result.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

87 participants in 1 patient group

Hepabulin IV
Experimental group
Treatment:
Drug: Hepabulin IV

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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