Non-A Non-B Hepatitis and the Safety of Intravenous Immune
Globulin, pH 4.2: A Retrospective Survey

Rousell, Ralph H.; Good, Robert A.; Pirofsky, Bernard; Schiff, Richard I.

doi:10.1159/000461753

Cited by 5 publications

(14 citation statements)

References 21 publications

(26 reference statements)

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“…Thus, the trial confirmed that the study IVIG did not transmit hepatitis. The results agree with the outcome of some retrospective or prospective studies [9][10][11]. Our data corroborate the clinical experience with the IVIG prep aration based on this procedure (Central Laboratory of the Swiss Red Cross Blood Transfusion Service, Sandoglobulin) which is now in use for approximately 10 years.…”

Section: Resultssupporting

confidence: 90%

Safety of Intravenous Immunoglobulin Preparations: A Prospective Multicenter Study to Exclude the Risk of Non-A, Non-B Hepatitis

Imbach¹,

Perret²,

Babington³

et al. 1991

Vox Sanguinis

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The risk of non-A, non-B hepatitis transmission by an intravenous immunoglobulin (IVIG) preparation was assessed in a prospective multicenter trial in 68 patients with primary immunodeficiency disorders (40 children or adolescents and 28 adults). During the 4-week prestudy evaluation period the clinical examinations and liver function tests including alanine aminotransferase, aspartate aminotransferase, yglutamyl transpeptidase, alkaline phosphatase, and bilirubin were normal in all patients. The treatment consisted of three infusions of 200 mg IVIG (pH 4; pepsin procedure) per kilogram body weight at 2-week intervals. During the observation period of 24 weeks following the first infusion of the study IVIG, the patients were monitored at regular time intervals. No clinical and laboratory signs of hepatitis or liver dysfunction were noticed. All patients completed the study. In 5 patients, one isolated alanine aminotransferase value and in another patient one γ-glutamyl transpeptidase value were moderately elevated, but always below 2.5 times the upper limit of the reference range. Similar isolated and transient elevations were observed for aspartate aminotransferase and alkaline phosphatase. It was concluded that the IVIG preparation did not transmit non-A, non-B hepatitis or other viral liver diseases.

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Section: Resultssupporting

confidence: 90%

Safety of Intravenous Immunoglobulin Preparations: A Prospective Multicenter Study to Exclude the Risk of Non-A, Non-B Hepatitis

Imbach¹,

Perret²,

Babington³

et al. 1991

Vox Sanguinis

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show abstract

“…, we published our experiences in 41 sub jects receiving monthly infusions of a nonmodified IGIV, pH 4.25 (Cutter Biological) followed up to 15 months [5]. In this series of immunodeficient patients, evidence of NANBH was not found in any subject.…”

Section: In 1988 Based Upon Reports Of Transmission Of Non-a Non-b Hmentioning

confidence: 87%

“…All except 1 of the patients had participated in our previous studies. Details of the patient entry and exclusion criteria are contained in our previous paper [5],…”

Section: Patientsmentioning

confidence: 99%

“…The center and patient numbering conforms to the numbering used in our previous study [5], It may be seen that only 5 of the 18 patients had less than 6 months exposure to IGIV before evaluation of their hepatic status commenced. During this prospective study, patients were followed for periods ranging from 14 to 26 months.…”

Section: Patientsmentioning

confidence: 99%

“…Patients included in this study at center 1 continued into the investigation without interruption from the previously reported study [5]. Thus the evaluation period for center 1 extended from April 1985 until October 1986.…”

Section: Period Of Studymentioning

confidence: 99%

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Prospective Study on the Hepatitis Safety of Intravenous Immunoglobulin, pH 4.25

Rousell¹,

Budinger²,

Pirofsky³

et al. 1991

Vox Sanguinis

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Recent reports of transmission by intravenous γ-globulin preparations of non-A non-B hepatitis (NANBH), including several cases that progressed to severe liver damage and death, have raised concerns about the safety of intravenous γ-globulin. However, the problem does not seem to be widespread. To assess this issue, we previously reported the results of liver function tests monitored in 41 patients with primary immunodeficiency treated with intravenous immunoglobulin (IGIV), pH 4.25 over periods ranging from 6 to 15 months. Eighteen of these patients at two of the three centers have now had serial serum glutamic pyruvic transaminase (SGPT) levels performed regularly at intervals of 1-5 weeks while continuing monthly intravenous infusions of nonmodified IGIV, pH 4.25 for an additional 14- 26 months. The standard dosage was 400mg per kg body weight IGIV, pH 4.25. Six lots of IGIV, pH4.25 were used. Transient minor SGPT elevations were observed in 5 of the patients on a total of 8 occasions. None of the elevations was considered indicative of NANBH or of any chronic hepatic disease. All patients remained negative for hepatitis B surface antigen throughout the study.

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Biochemistry and safety of native intravenous gammaglobulin (IGIV, pH 4.25)

Schwartz

1988

J of Clinical Apheresis

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Non-A Non-B Hepatitis and the Safety of Intravenous Immune Globulin, pH 4.2: A Retrospective Survey

Cited by 5 publications

References 21 publications

Safety of Intravenous Immunoglobulin Preparations: A Prospective Multicenter Study to Exclude the Risk of Non-A, Non-B Hepatitis

Safety of Intravenous Immunoglobulin Preparations: A Prospective Multicenter Study to Exclude the Risk of Non-A, Non-B Hepatitis

Prospective Study on the Hepatitis Safety of Intravenous Immunoglobulin, pH 4.25

Biochemistry and safety of native intravenous gammaglobulin (IGIV, pH 4.25)

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