Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)

Completed · Phase 4

Conditions studied: Anti-Hepatitis A Antibody Levels in Heathy Subjects

In brief

This was a single center, open-label, single-arm study in which approximately 28 Hepatitis A virus (HAV)-seronegative healthy subjects were enrolled. There was a screening period of up to 28 days during which subjects were screened for enrollment in the study. Healthy subjects received a single intramuscular (IM) dose of GamaSTAN (0.2 mL/kg), followed by a pharmacokinetic (PK) sampling period of 150 days (approximately 5 half-lives). The protective levels of anti-HAV antibodies were assessed up to 60 days after the administration of GamaSTAN. A PK curve was obtained during the PK sampling period.

Key facts

Study ID

NCT03351933

Run by

Grifols Therapeutics LLC

People needed

28

Starts

2017-10-31

Expected to finish

2018-07-19

Last updated by the study team

2019-07-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male subjects from 18 to 55 years of age, inclusive, or female subjects from 18 to 65 years of age, inclusive
• Subjects with a body mass index (BMI) of 18.5 to 29.9 kg/m2
• Body weight greater than or equal to 50 kg at screening
• Subjects willing and able to provide written informed consent
• Subjects in good health in the judgment of the Investigator, as determined by medical history, physical examination, vital signs, ECG and laboratory assessments
• A female study subject must meet one of the following criteria:
• If a female of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to study treatment administration and during the entire study duration. An acceptable method of contraception includes one of the following:
• Abstinence from heterosexual intercourse (i.e. when abstinence is the preferred and usual lifestyle of the subject; periodic abstinence is not acceptable)
• Non-estrogen containing hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
• Intrauterine device without hormones
• Condom with spermicide
• Diaphragm or cervical cap with spermicide
• Vasectomized partner (minimum 6 months since vasectomy prior to study treatment administration)
• If a female of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses prior to study treatment administration)
• A male study subject must agree to use one of the accepted contraceptive regimens during the entire study duration;
• Abstinence from heterosexual intercourse
• Female partner with condom with spermicide used by male study subject
• Female partner of non-childbearing potential
• Male sterilization (if proof of sterilization is not provided, the subject must agree to use one of the above accepted contraceptive methods)
• A male study subject must agree not to impregnate a female or donate sperm during the entire study duration

You may not qualify if…

• Subject vaccinated against HAV, as documented the in medical history at the screening visit
• Subject with positive anti-HAV antibodies in blood sample at the screening visit
• Subject who previously received any type of IG, including HAV IG within the past 12 months prior to study treatment administration
• Subject with prolonged International Normalized Ratio (INR) or activated partial thromboplastin time (aPTT) at the screening visit
• Subject with a platelet count below 100×109/L at the screening visit
• Subject suffering from some acute or chronic medical, surgical or psychiatric significant condition or laboratory abnormality at the screening visit or prior to study treatment administration that, according to Investigator judgement, may increase the risk associated with study participation or study treatment administration, or may interfere with the successful completion or interpretation of the study results
• Subject with a history of the following: angioedema, cardiac arrhythmia, angina pectoris, myocardial infarction, cerebrovascular accident, cardiac failure, thrombotic events, embolism, coagulopathy, diabetes mellitus, hyperlipidaemia, nephrotic syndrome, acute renal injury, chronic obstructive pulmonary disease, asthma, hepatic disease, reticuloendothelial system dysfunction, or nervous system disorder
• Subject with known personal or family history of abnormal bleeding episodes
• Subject not willing to receive study treatment via IM route of administration or unable to receive study treatment via IM route of administration
• Subject with cardiovascular risk factors based on medical history: active tobacco smoking and/or ongoing diabetes mellitus at the screening visit
• Subject with thrombosis risk factors: prolonged immobilization within 2 months prior to the screening visit, history of venous or arterial thrombosis, use of estrogens (30 days prior to the study drug administration), indwelling central vascular catheters and hyperviscosity or hypercoagulable states
• Subject with known history of hypersensitivity/allergic reaction to blood/plasma products
• Subject with known selective IgA deficiency (with or without antibodies to IgA)
• Subject who received any plasma-derived product infusion within 12 months prior to study treatment administration
• Subject who received a blood or plasma transfusion within 12 months prior to study treatment administration
• Subject with systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg at the screening visit and prior to treatment administration
• Subject with anemia (hemoglobin <12 g/dL in women and 13 g/dL in men) at the screening visit
• Subjects with proteinuria (>1+ on urine dipstick), blood urea nitrogen (BUN) or creatinine greater than the upper limit of normal at the screening visit
• Subject with liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT] and gamma-glutamyl transferase [GGT]) levels greater than the upper limit of normal at screening visit
• Subject who received any dose of parenteral, oral, or inhaled corticosteroids, immunosuppressants, or immunomodulators within 6 weeks prior to the screening visit
• Subject who received any live virus vaccine within five months prior to the screening visit
• Subject not willing to postpone receiving any live virus vaccines until 6 months after receiving IP
• Currently receiving any anti-viral treatment, regardless of the route of administration
• Subject with virus safety laboratory results (serology and/or nucleic acid amplification technology [NAT]) indicative of a current infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or parvovirus B19 (B19V) at the screening visit
• Participated in another clinical trial within 30 days prior to the screening visit or has received any IPs within 3 months prior to the screening visit

Where it is running

• Vince & Associates Clinical Research, Inc. — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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