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The purpose of this study is to determine the immunologic and overall safety associated with long-term use of Alphanate in subjects diagnosed with severe hemophilia A (Factor VIII:C less than 0.01 IU/ml), who have been previously treated with plasma-derived Factor VIII products other than Alphanate and who have no history of developing either antibody inhibitors to Factor VIII or nonspecific inhibitors of coagulation.
This is a Phase IV, non-randomized, multicenter study of at least 50 evaluable subjects diagnosed with severe hemophilia A. Enrolled subjects will be treated at home and with in-clinic therapy exclusively with Alphanate as their sole source of Factor VIII concentrate for prophylaxis and treatment of all bleeding episodes and surgical procedures. Subjects will be treated for at least 2 years and a minimum of 50 exposure days, or if 50 exposure days are not reached, for a maximum of 30 months and in accordance with the subject's usual pre-study treatment regimen. Subjects will continue treatment as above or until they develop inhibitors to Factor VIII at a titer greater than or equal to 5 Bethesda units (BU/ml); Factor VIII becomes ineffective at providing hemostasis, or the subject exhibits severe or serious adverse events that prevent completion of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coagulation factor VIII (Human) | Experimental | Anti-Hemophilic coagulation factor VIII (Human) Alphanate SD/HT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alphanate SD/HT | Drug | Plasma-derived preparation of Factor VIII |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Factor VIII (FVIII) Inhibitor Development | Incidence of FVIII inhibitor development was defined as any result determined positive at a central laboratory (inhibitor titer of greater than 0.6 modified Bethesda Units/milliliters [BU/mL]) using Nijmegen modification of the Bethesda assay. | Up to Month 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product or study treatment, and which did not necessarily have a causal relationship with this administration. Here end of study is defined as completion/discontinuation visit. | Up to Month 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Ken Woodward | Instituto Grifols SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oddzial Chorob Wewnetrznych i Hematologii | Poznan | Szkolna | Poland | |||
| Katedra i Klinika Hematologii Collegium Medicum UJ |
Male participants diagnosed with severe hemophilia A who have been previously treated with Factor VIII concentrates, cryoprecipitate, or whole blood for a total of 150 cumulative exposure were enrolled. A total of 51 participants were enrolled out of which, 50 participants received the treatment. A total of 45 participants completed the study.
This study was conducted in Poland at 2 centers from April 8, 2003 to December 14, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alphanate | Participants were treated at home and with in-clinic therapy exclusively with Alphanate as their sole source of Factor VIII (FVIII) concentrate for prophylaxis and treatment of all bleeding episodes and surgical procedures for a period of at least two years and a minimum of 50 exposure days, or, if 50 exposure days were not reached, for a maximum of 30 months. An exposure day was defined as any day on which a participant received one or more infusions of any FVIII containing product. Alphanate was administered intravascularly in accordance with the participant's usual pre-study treatment regimen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who received at least one infusion of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alphanate | Participants were treated at home and with in-clinic therapy exclusively with Alphanate as their sole source of Factor VIII (FVIII) concentrate for prophylaxis and treatment of all bleeding episodes and surgical procedures for a period of at least two years and a minimum of 50 exposure days, or, if 50 exposure days were not reached, for a maximum of 30 months. An exposure day was defined as any day on which a participant received one or more infusions of any FVIII containing product. Alphanate was administered intravascularly in accordance with the participant's usual pre-study treatment regimen. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Factor VIII (FVIII) Inhibitor Development | Incidence of FVIII inhibitor development was defined as any result determined positive at a central laboratory (inhibitor titer of greater than 0.6 modified Bethesda Units/milliliters [BU/mL]) using Nijmegen modification of the Bethesda assay. | Safety population included all participants who received at least one infusion of study medication. | Posted | Count of Participants | Participants | Up to Month 30 |
|
Up to Month 30
Safety population included all participants who received at least one infusion of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alphanate | Participants were treated at home and with in-clinic therapy exclusively with Alphanate as their sole source of Factor VIII (FVIII) concentrate for prophylaxis and treatment of all bleeding episodes and surgical procedures for a period of at least two years and a minimum of 50 exposure days, or, if 50 exposure days were not reached, for a maximum of 30 months. An exposure day was defined as any day on which a participant received one or more infusions of any FVIII containing product. Alphanate was administered intravascularly in accordance with the participant's usual pre-study treatment regimen. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rhonda Griffin | Grifols | 919-316-6693 | rhonda.griffin@grifols.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 10, 2007 | Mar 18, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2010 | Mar 18, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Change From Baseline in Alkaline Phosphatase | The Baseline value was the last non-missing value before study drug was taken and end of study was defined as completion/discontinuation visit. Change from Baseline was calculated by subtracting Baseline value from the post-infusion visit value. | Baseline and Quarterly Visit 1 (Month 3), 2 (Month 6), 3 (Month 9), 4 (Month 12), 5 (Month 15), 6 (Month 18), 7 (Month 21), 8 (Month 24), 9 (Month 27) and 10 (Month 30) |
| Change From Baseline in Alanine Aminotransferase | The Baseline value was the last non-missing value before study drug was taken and end of study was defined as completion/discontinuation visit. Change from Baseline was calculated by subtracting Baseline value from the post-infusion visit value. | Baseline and Quarterly Visit 1 (Month 3), 2 (Month 6), 3 (Month 9), 4 (Month 12), 5 (Month 15), 6 (Month 18), 7 (Month 21), 8 (Month 24), 9 (Month 27) and 10 (Month 30) |
| Change From Baseline in Aspartate Aminotransferase | The Baseline value was the last non-missing value before study drug was taken and end of study was defined as completion/discontinuation visit. Change from Baseline was calculated by subtracting Baseline value from the post-infusion visit value. | Baseline and Quarterly Visit 1 (Month 3), 2 (Month 6), 3 (Month 9), 4 (Month 12), 5 (Month 15), 6 (Month 18), 7 (Month 21), 8 (Month 24), 9 (Month 27) and 10 (Month 30) |
| Change From Baseline in Lactate Dehydrogenase | The Baseline value was the last non-missing value before study drug was taken and end of study was defined as completion/discontinuation visit. Change from Baseline was calculated by subtracting Baseline value from the post-infusion visit value. | Baseline and Quarterly Visit 1 (Month 3), 2 (Month 6), 3 (Month 9), 4 (Month 12), 5 (Month 15), 6 (Month 18), 7 (Month 21), 8 (Month 24), 9 (Month 27) and 10 (Month 30) |
| Change From Baseline in Bilirubin | The Baseline value was the last non-missing value before study drug was taken and end of study was defined as completion/discontinuation visit. Change from Baseline was calculated by subtracting Baseline value from the post-infusion visit value. | Baseline and Quarterly Visit 1 (Month 3), 2 (Month 6), 3 (Month 9), 4 (Month 12), 5 (Month 15), 6 (Month 18), 7 (Month 21), 8 (Month 24), 9 (Month 27) and 10 (Month 30) |
| Change From Baseline in Blood Urea Nitrogen | The Baseline value was the last non-missing value before study drug was taken and end of study was defined as completion/discontinuation visit. Change from Baseline was calculated by subtracting Baseline value from the post-infusion visit value. | Baseline and Quarterly Visit 1 (Month 3), 2 (Month 6), 3 (Month 9), 4 (Month 12), 5 (Month 15), 6 (Month 18), 7 (Month 21), 8 (Month 24), 9 (Month 27) and 10 (Month 30) |
| Change From Baseline in Creatinine | The Baseline value was the last non-missing value before study drug was taken and end of study was defined as completion/discontinuation visit. Change from Baseline was calculated by subtracting Baseline value from the post-infusion visit value. | Baseline and Quarterly Visit 1 (Month 3), 2 (Month 6), 3 (Month 9), 4 (Month 12), 5 (Month 15), 6 (Month 18), 7 (Month 21), 8 (Month 24), 9 (Month 27) and 10 (Month 30) |
| Number of Participants Human Immunodeficiency Virus Type 1 and 2 (HIV-1/HIV-2), Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Parvovirus B19 -Negative at Baseline Who Are Seropositive for Any of These Viruses | Seroconversion based on Enzyme-linked Immunosorbent Assay (ELISA). Seronegative defined as non-reactive in an ELISA test for antibody to the virus in question. Seropositive defined as reactive in an ELISA test for antibody to the virus in question. | Up to Month 30 |
| Krakow |
| Poland |
| Missing |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Subjects with antibody inhibitors to FVIII | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Adverse Events (AE) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product or study treatment, and which did not necessarily have a causal relationship with this administration. Here end of study is defined as completion/discontinuation visit. | Safety population included all participants who received at least one infusion of study medication. | Posted | Count of Participants | Participants | Up to Month 30 |
|
|
|
| Secondary | Change From Baseline in Alkaline Phosphatase | The Baseline value was the last non-missing value before study drug was taken and end of study was defined as completion/discontinuation visit. Change from Baseline was calculated by subtracting Baseline value from the post-infusion visit value. | Safety population included all participants who received at least one infusion of study medication. Number analyzed signifies number of participants evaluable at each specified timepoint. | Posted | Mean | Standard Deviation | microkatal per liter (μkat/L) | Baseline and Quarterly Visit 1 (Month 3), 2 (Month 6), 3 (Month 9), 4 (Month 12), 5 (Month 15), 6 (Month 18), 7 (Month 21), 8 (Month 24), 9 (Month 27) and 10 (Month 30) |
|
|
|
| Secondary | Change From Baseline in Alanine Aminotransferase | The Baseline value was the last non-missing value before study drug was taken and end of study was defined as completion/discontinuation visit. Change from Baseline was calculated by subtracting Baseline value from the post-infusion visit value. | Safety population included all participants who received at least one infusion of study medication. Number analyzed signifies number of participants evaluable at each specified timepoint | Posted | Mean | Standard Deviation | μkat/L | Baseline and Quarterly Visit 1 (Month 3), 2 (Month 6), 3 (Month 9), 4 (Month 12), 5 (Month 15), 6 (Month 18), 7 (Month 21), 8 (Month 24), 9 (Month 27) and 10 (Month 30) |
|
|
|
| Secondary | Change From Baseline in Aspartate Aminotransferase | The Baseline value was the last non-missing value before study drug was taken and end of study was defined as completion/discontinuation visit. Change from Baseline was calculated by subtracting Baseline value from the post-infusion visit value. | Safety population included all participants who received at least one infusion of study medication. Number analyzed signifies number of participants evaluable at each specified timepoint. | Posted | Mean | Standard Deviation | μkat/L | Baseline and Quarterly Visit 1 (Month 3), 2 (Month 6), 3 (Month 9), 4 (Month 12), 5 (Month 15), 6 (Month 18), 7 (Month 21), 8 (Month 24), 9 (Month 27) and 10 (Month 30) |
|
|
|
| Secondary | Change From Baseline in Lactate Dehydrogenase | The Baseline value was the last non-missing value before study drug was taken and end of study was defined as completion/discontinuation visit. Change from Baseline was calculated by subtracting Baseline value from the post-infusion visit value. | Safety population included all participants who received at least one infusion of study medication. Number analyzed signifies number of participants evaluable at each specified timepoint. | Posted | Mean | Standard Deviation | μkat/L | Baseline and Quarterly Visit 1 (Month 3), 2 (Month 6), 3 (Month 9), 4 (Month 12), 5 (Month 15), 6 (Month 18), 7 (Month 21), 8 (Month 24), 9 (Month 27) and 10 (Month 30) |
|
|
|
| Secondary | Change From Baseline in Bilirubin | The Baseline value was the last non-missing value before study drug was taken and end of study was defined as completion/discontinuation visit. Change from Baseline was calculated by subtracting Baseline value from the post-infusion visit value. | Safety population included all participants who received at least one infusion of study medication. Number analyzed signifies number of participants evaluable at each specified timepoint. | Posted | Mean | Standard Deviation | micromole per liter (μmol/L) | Baseline and Quarterly Visit 1 (Month 3), 2 (Month 6), 3 (Month 9), 4 (Month 12), 5 (Month 15), 6 (Month 18), 7 (Month 21), 8 (Month 24), 9 (Month 27) and 10 (Month 30) |
|
|
|
| Secondary | Change From Baseline in Blood Urea Nitrogen | The Baseline value was the last non-missing value before study drug was taken and end of study was defined as completion/discontinuation visit. Change from Baseline was calculated by subtracting Baseline value from the post-infusion visit value. | Safety population included all participants who received at least one infusion of study medication. Number analyzed signifies number of participants evaluable at each specified timepoint. | Posted | Mean | Standard Deviation | millimole per liter (mmol/L) | Baseline and Quarterly Visit 1 (Month 3), 2 (Month 6), 3 (Month 9), 4 (Month 12), 5 (Month 15), 6 (Month 18), 7 (Month 21), 8 (Month 24), 9 (Month 27) and 10 (Month 30) |
|
|
|
| Secondary | Change From Baseline in Creatinine | The Baseline value was the last non-missing value before study drug was taken and end of study was defined as completion/discontinuation visit. Change from Baseline was calculated by subtracting Baseline value from the post-infusion visit value. | Safety population included all participants who received at least one infusion of study medication.Number analyzed signifies number of participants evaluable at each specified timepoint. | Posted | Mean | Standard Deviation | micromole per liter (μmol/L) | Baseline and Quarterly Visit 1 (Month 3), 2 (Month 6), 3 (Month 9), 4 (Month 12), 5 (Month 15), 6 (Month 18), 7 (Month 21), 8 (Month 24), 9 (Month 27) and 10 (Month 30) |
|
|
|
| Secondary | Number of Participants Human Immunodeficiency Virus Type 1 and 2 (HIV-1/HIV-2), Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Parvovirus B19 -Negative at Baseline Who Are Seropositive for Any of These Viruses | Seroconversion based on Enzyme-linked Immunosorbent Assay (ELISA). Seronegative defined as non-reactive in an ELISA test for antibody to the virus in question. Seropositive defined as reactive in an ELISA test for antibody to the virus in question. | Safety population included all participants who received at least one infusion of study medication. | Posted | Count of Participants | Participants | Up to Month 30 |
|
|
|
| 0 |
| 50 |
| 4 |
| 50 |
| 22 |
| 50 |
| Device Malfunction | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Post Procedural Discharge | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Skin Abrasion | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| Headche | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
Site may publish results from the Study, after providing Sponsor thirty days' notice prior to submitting a manuscript or other materials related to the Study to any outside party. At Sponsors' request, Site will remove any Confidential Information (other than Study results), and Site will upon Sponsors' request, delay publication or presentation for a period of up to one hundred twenty days to allow Sponsor to protect its interests in any Sponsor Inventions.
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011498 |
| Protein Precursors |
| D001685 | Biological Factors |
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| Change at Quarterly Visit 2 (Month 6) |
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| Change at Quarterly Visit 3 (Month 9) |
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| Change at Quarterly Visit 4 (Month 12) |
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| Change at Quarterly Visit 5 (Month 15) |
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| Change at Quarterly Visit 6 (Month 18) |
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| Change at Quarterly Visit 7 (Month 21) |
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| Change at Quarterly Visit 8 (Month 24) |
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| Change at Quarterly Visit 9 (Month 27) |
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| Change at Quarterly Visit 10 (Month 30) |
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| Change at Quarterly Visit 2 (Month 6) |
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| Change at Quarterly Visit 3 (Month 9) |
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| Change at Quarterly Visit 4 (Month 12) |
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| Change at Quarterly Visit 5 (Month 15) |
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| Change at Quarterly Visit 6 (Month 18) |
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| Change at Quarterly Visit 7 (Month 21) |
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| Change at Quarterly Visit 8 (Month 24) |
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| Change at Quarterly Visit 9 (Month 27) |
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| Change at Quarterly Visit 10 (Month 30) |
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| Change at Quarterly Visit 2 (Month 6) |
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| Change at Quarterly Visit 3 (Month 9) |
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| Change at Quarterly Visit 4 (Month 12) |
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| Change at Quarterly Visit 5 (Month 15) |
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| Change at Quarterly Visit 6 (Month 18) |
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| Change at Quarterly Visit 7 (Month 21) |
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| Change at Quarterly Visit 8 (Month 24) |
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| Change at Quarterly Visit 9 (Month 27) |
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| Change at Quarterly Visit 10 (Month 30) |
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| Change at Quarterly Visit 2 (Month 6) |
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| Change at Quarterly Visit 3 (Month 9) |
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| Change at Quarterly Visit 4 (Month 12) |
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| Change at Quarterly Visit 5 (Month 15) |
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| Change at Quarterly Visit 6 (Month 18) |
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| Change at Quarterly Visit 7 (Month 21) |
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| Change at Quarterly Visit 8 (Month 24) |
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| Change at Quarterly Visit 9 (Month 27) |
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| Change at Quarterly Visit 10 (Month 30) |
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| Change at Quarterly Visit 2 (Month 6) |
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| Change at Quarterly Visit 3 (Month 9) |
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| Change at Quarterly Visit 4 (Month 12) |
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| Change at Quarterly Visit 5 (Month 15) |
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| Change at Quarterly Visit 6 (Month 18) |
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| Change at Quarterly Visit 7 (Month 21) |
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| Change at Quarterly Visit 8 (Month 24) |
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| Change at Quarterly Visit 9 (Month 27) |
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| Change at Quarterly Visit 10 (Month 30) |
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| Change at Quarterly Visit 2 (Month 6) |
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| Change at Quarterly Visit 3 (Month 9) |
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| Change at Quarterly Visit 4 (Month 12) |
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| Change at Quarterly Visit 5 (Month 15) |
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| Change at Quarterly Visit 6 (Month 18) |
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| Change at Quarterly Visit 7 (Month 21) |
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| Change at Quarterly Visit 8 (Month 24) |
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| Change at Quarterly Visit 9 (Month 27) |
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| Change at Quarterly Visit 10 (Month 30) |
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| Change at Quarterly Visit 2 (Month 6) |
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| Change at Quarterly Visit 3 (Month 9) |
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| Change at Quarterly Visit 4 (Month 12) |
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| Change at Quarterly Visit 5 (Month 15) |
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| Change at Quarterly Visit 6 (Month 18) |
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| Change at Quarterly Visit 7 (Month 21) |
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| Change at Quarterly Visit 8 (Month 24) |
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| Change at Quarterly Visit 9 (Month 27) |
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| Change at Quarterly Visit 10 (Month 30) |
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| Hepatitis B Virus (HBsAg) |
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| Hepatitis B Virus (HBsAb) |
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| Hepatitis C Virus |
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| Parvovirus B19 |
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